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For peer review only
The effectiveness of the Baby Friendly Community Initiative
in Italy: a non-randomised controlled study
Journal: BMJ Open
Manuscript ID bmjopen-2015-010232
Article Type: Research
Date Submitted by the Author: 09-Oct-2015
Complete List of Authors: Cattaneo, Adriano; Institute for Maternal and Child Health IRCCS Burlo Garofolo, Health Services Research and International Health Bettinelli, Maria; Local Health Authority, Maternal and Child Health Unit, Department of Primary Care Chapin, Elise; Italian Committee for UNICEF, Baby Friendly Initiatives Macaluso, Anna; Institute for Maternal and Child Health IRCCS Burlo Garofolo, Health Services Research and International Health Córdova do Espírito Santo, Lílian; National Council for Technological and Scientific Development Murante, Anna Maria; Scuola Superiore Sant'Anna, Istituto di MAnagement - Laboratorio Management e sanità Montico, Marcella; Institute for Maternal and Child Health IRCCS Burlo Garofolo, Epidemiology and Biostatistics
<b>Primary Subject Heading</b>:
Health services research
Secondary Subject Heading: Paediatrics
Keywords: Breastfeeding, Baby-Friendly Initiatives, Italy
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The effectiveness of the Baby Friendly Community Initiative in Italy: a non-randomised controlled
study
Running title: Baby-Friendly Community Initiative
Adriano Cattaneo, Maria Enrica Bettinelli, Elise Chapin, Anna Macaluso, Lílian Córdova do
Espírito Santo, Anna Maria Murante, Marcella Montico, on behalf of the BFCI Study Group
Health Services Research and International Health, Institute for Maternal and Child Health IRCCS
Burlo Garofolo, Via dell’Istria 65/1, 34137 Trieste, Italy (Adriano Cattaneo, Anna Macaluso),
Maternal and Child Health Unit, Department of Primary Care, Local Health Authority, 20122
Milan, Italy (Maria Enrica Bettinelli), Baby Friendly Initiatives, Italian Committee for UNICEF,
00185 Rome, Italy (Elise M. Chapin), Grant recipient, National Council for Technological and
Scientific Development, Porto Alegre, Brazil (Lílian Córdova do Espírito Santo), Management and
Health Laboratory, Institute of Management, Scuola Superiore Sant’Anna, 56127 Pisa, Italy (Anna
Maria Murante), Epidemiology and Biostatistics, Institute for Maternal and Child Health IRCCS
Burlo Garofolo, 34137 Trieste, Italy (Marcella Montico).
Correspondence to: [email protected]; mobile +393206797647
Keywords: breastfeeding, Baby Friendly Initiatives, Italy
Word count (text): 4389
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Abstract
Objective. To assess the effectiveness of the Baby Friendly Community Initiative (BFCI) on
exclusive breastfeeding to six months.
Design. Controlled, non-randomised trial.
Setting. 18 Local Health Authorities in 9 regions of Italy.
Participants. 5094 mother/infant dyads in three cohorts followed-up to 12 months after birth in three
rounds of data collection: at baseline, after implementation of the intervention in the early
intervention group, and after implementation in the late intervention group. 689 (14%) dyads did
not complete the study.
Intervention. Implementation of the 7 Steps of the BFCI.
Main outcome measures. The rate of exclusive breastfeeding at 6 months was the primary outcome;
breastfeeding at discharge, 3 and 12 months were also measured.
Results. The crude rates of exclusive breastfeeding at discharge, 3 and 6 months, and of any
breastfeeding at 6 and 12 months increased at each round of data collection after baseline in both
the early and late intervention groups. At the end of the project, 10% of infants were exclusively
breastfed at 6 months and 38% were continuing to breastfeed at 12 months. However, the
comparison by adjusted rates and logistic regression failed to show statistically significant
differences between groups and rounds of data collection in the intention-to-treat analysis, but also
when compliance with the intervention and training coverage were taken into account.
Conclusions. The study failed to demonstrate an effect of the BFCI on the rates of breastfeeding.
This may be due to, among other factors, to the time needed to observe an effect on breastfeeding
following this complex intervention.
Word count: 254
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Strengths and limitations of this study
• Implementation of a complex multisectoral intervention for the protection, promotion and
support of breastfeeding, with synergistic engagement of many different actors.
• Controlled, non-randomised trial with possible effect measured in three rounds of data
collection, before and after a phased implementation of the intervention.
• Rates of breastfeeding compared between groups of local health authorities by intention to
treat, compliance with the intervention and training coverage.
• Rates of breastfeeding increased during the four years of the study, but this may not have had
the power to identify small differences as significant.
• The effects of a complex intervention such as the Baby Friendly Community Initiative may
need more than the four years of the study to be observed.
What is already known on this subject
• The Baby Friendly Hospital Initiative (BFHI) is an evidence-based effective intervention that
contributes to increasing the initiation, exclusivity and duration of breastfeeding.
• The BFHI alone, however, does not help achieve exclusive breastfeeding to six months and
continuation, with adequate complementary foods, up to two years and beyond.
• Interventions at the community level are needed to improve breastfeeding exclusivity to six
months and continuation well into the second year of life.
What this study adds
• An intervention based on the Baby Friendly Community Initiative (BFCI) failed to
demonstrate an effect on the rates of breastfeeding up to 12 months.
• This may be due, among other factors, to the time needed to observe an effect, probably
longer than the duration of this study.
• This study did not allow to determine that the BFCI is effective, but paved the way for better
practices in the study and other areas.
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Introduction
The Baby Friendly Hospital Initiative (BFHI) is an evidence-based effective intervention that
contributes to increasing the initiation, exclusivity and duration of breastfeeding.1,2 Alone, however,
it cannot achieve the goals recommended by WHO, UNICEF and many national and professional
policies, i.e. exclusive breastfeeding (EBF) for six months and continued breastfeeding, with
adequate complementary foods, up to two years and beyond.3-6 Worldwide, rates of EBF to 6
months fall short of those recommended;7-9 interventions at the community level, in addition to the
hospital-based ones, are needed to improve them.10 Several community interventions, such as
primary-care-based educational programmes,11,12 competent professional support at home or in
health facilities,13 home visits by trained professionals,
14 home-based peer counselling,
15 or the
involvement of fathers,16,17 have been shown to be effective. In some countries, these interventions
have been integrated into Baby Friendly Community Initiatives (BFCI),18-20 generally considered as
an appropriate framework.21
The Italian Committee for UNICEF, which promotes and coordinates the BFHI in Italy, established
a working group to adapt and develop the BFCI for the national health system, in collaboration with
the Local Health Authority (LHA) of Milan, where it was initially piloted and later launched in
2007. The BFCI is based on the Seven Point Plan used in the UK and ew Zealand, and includes
tools for planning, implementation, monitoring and evaluation described in a companion paper.22
Briefly, the 7 Steps of the BFCI (Table 1) are supposed to be implemented in all the non-hospital-
based health facilities of a LHA. These include health centres, mother and child health clinics,
family health centres, public and private medical, obstetric and paediatric practices, day care
centres, and, where present, public pharmacies. All the health and social workers of these facilities
have to be trained, in courses of different duration, to implement a policy previously developed by a
multidisciplinary team and approved by the LHA management. Health professionals are trained to
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help breastfeeding as well as formula-feeding mothers when and where they ask for support.
Moreover, the LHA is required to create breastfeeding-friendly environments not only in its
premises and facilities, but also in other community and public places, such as workplaces and
shops, environments where nursing mothers feel welcome and breastfeeding is considered a natural
act that can be done in public. Health and social centres are encouraged to collaborate with other
services and groups that offer support for infant feeding, including mother-to-mother and peer
support groups that are not part of the health care system. Finally, the LHA is required to abide by
the International Code of Marketing of Breast-Milk Substitutes.
Table 1. The Seven Steps of the Baby Friendly Community Initiative
1. Have a written breastfeeding policy that is routinely communicated to all staff.
2. Train all staff to implement the breastfeeding policy.
3. Inform all pregnant women and their families about the benefits and management of
breastfeeding.
4. Support mothers to initiate and sustain breastfeeding.
5. Encourage exclusive breastfeeding up to 6 months of age, the introduction of appropriate
complementary foods after 6 months, and continued breastfeeding.
6. Provide a welcoming atmosphere for breastfeeding families.
7. Promote cooperation between health care staff, breastfeeding support groups, and the local
community.
In 2009, 18 LHAs, which had expressed an interest in the BFCI, accepted the invitation from the
Italian Committee for UNICEF of working towards BFCI accreditation. This was an opportunity to
set up a research project to look at the effectiveness of the BFCI in terms of rates and duration of
EBF to six months, a recognized research priority.23 The methods and some baseline data of this
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project have already been reported in a second companion paper.24 This third paper reports the final
results.
Methods
The methods of this research project have already been described.24 Briefly, this non-randomised
controlled trial involved 18 LHAs in 9 regions of northern and central Italy. The study design
(Figure 1) demanded that 9 LHAs started implementing the 7 Steps after baseline data collection
(early intervention group), while the remaining 9 would start about 12 months later, after a second
round of data collection (late intervention group); a third round of data collection would be carried
out about 12 months after implementing the intervention in the latter group. Some LHAs, however,
had already started implementing BFCI activities before the study was designed: Milan because it
had a leading role in developing the materials and tools and pilot testing them; others because they
had been part of the working group that adapted the BFCI for Italy, or had previously worked on
developing draft policies, or had conducted some limited staff training, especially where there was a
Baby Friendly Hospital (BFH). For these reasons, it was impossible to randomize the 18 LHAs into
early and late intervention groups. They were instead paired based on the reported rate of EBF at
around 5 months of age, on their population, and on their setting and population density (i.e.
whether the LHA was mostly urban or rural). Within each pair, LHAs were then assigned to the
early or late intervention groups based on whether they had already implemented some activity or
not.
The rate of EBF at 6 months was the primary outcome of the study. To compare these rates between
groups and within them over time, data were gathered in three rounds. At each round of data
collection, starting in the fall of 2009, cohorts of infants were followed from birth to 12 months,
with interviews at discharge and at 3, 6 and 12 months, in each of the three rounds. Mothers were
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recruited consecutively in the hospitals serving the 18 LHAs, until the intended sample size was
attained. After obtaining informed consent, the first interview with the mother was conducted face-
to-face just before discharge using a 36-item questionnaire that included three questions on feeding
both within the previous 24 hours and from birth (Has the baby had breastmilk? Has the baby had
formula? Has the baby had other fluids, and if so what?), questions on potential confounders, as
well as basic information used to identify the subject. If, for any reason, it was impossible to
interview the mother during hospital stay, the interview was carried out by telephone within one
week of giving birth; this occurred with 212 (12%) mothers. These interviews were performed by
the staff in charge of the BFCI in each LHA. The interviews at 3, 6 and 12 months included five
yes/no questions on foods and fluids taken in the previous 24 hours (breastmilk, formula, animal
milks, non-nutritive fluids, and solids or semisolids), plus an additional question for infants fed only
breastmilk on other foods and fluids taken in the previous 7 days, to compensate for the well-known
overestimate of EBF using a 24-hour recall.25,26 These questions, complemented in the interview at
12 months by questions on breastfeeding problems and ways they were solved or not, were
administered by researchers of the Management and Health Laboratory at Scuola Superiore
Sant’Anna, Pisa, specialized in conducting surveys using Computer-Assisted Telephone
Interviewing (CATI) methods. These interviewers were unaware of the assignment to the early or
late intervention groups. The different categories of feeding were automatically derived from the
different combinations of answers.27,28 All infants were followed up to 12 months of age
irrespective of their feeding status. The interviews at 12 months in the third round of data collection
were concluded in March of 2012.
The sample size for each cohort was established on the assumption that the BFCI could result in a
10% increase in the rate of EBF at 6 months, from the baseline 25% estimate, as a weighted and
adjusted average of the range from 10% to 60% reported for 2007 or 2008 by the 18 LHAs at
around 5 months of age. These reports were based on data gathered most often at immunization or,
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less often, during small cross-sectional or longitudinal surveys, with questionnaires, definitions of
feeding categories and recall periods that were not standardized, and on samples that might have not
represented the population. Based on the above assumption, the sample size for a controlled trial
with a precision of 5% and a power of 80% would amount to 348 subjects per study arm. Due to the
cluster design of the study, this number was doubled to 1392 subjects, 696 per study arm,
considering a possible and conservative design effect of 2. The final sample size of 1740 mother-
infant pairs per round of data collection takes into account a possible 20% loss to follow up. This
sample size was then distributed among the 18 LHAs in proportion to their estimated number of
annual births. Exclusion criteria were a birth weight lower than 2000 g, any post-partum condition
that required admission into a neonatal intensive care unit, the practical impossibility of conducting
the interview (mother or relative unable to understand Italian, English, French or Spanish), and
residence outside the area covered by the LHA. Twins were recruited as separate subjects. As
described in the first companion paper,22 data collection included a self-assessment questionnaire
completed by the 18 LHAs on the progress made in implementing the 7 Steps, each step having a
set of 3 to 11 criteria based on the same model used for the self-assessment of the BFHI.29 In
addition, each LHA was supposed to develop annual action plans and to report on the degree of
implementation.
After a phase of planning and pilot testing of the tools,22 baseline data collection started in
September 2009 and was successfully completed; the second and third rounds were completed as
planned. Data from face-to-face interviews were manually inputted into customized EpiData Files,
and later exported to MS Excel, by the research assistants in each of the 18 sites. Those from the
CATI system (at 3, 6 and 12 months) were recorded answer-by-answer in real time and
automatically saved into a separate relational database, one for each round of data collection, and
were then extracted to MS Excel files. Finally, all the data from each round were integrated into a
single MS Excel file in Trieste, using the individual ID codes for record linkage. Data were then
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checked for completeness, consistency and accuracy, and research assistants at the 18 sites were
notified of possible mistakes for correction after comparison with the original paper records. Data
analysis was carried out using Stata 13. Differences in baseline characteristics were analysed with
Chi squared test or t-test as appropriate. Differences in rates of breastfeeding between early and late
intervention groups at different time points were assessed with logistic regression models using a
backward stepwise selection approach that retained only the variables associated with breastfeeding
at the 0.05 level of significance and took into account the effect of the cluster design (cluster
command in Stata 13). The tested variables were: maternal age, nationality, education, paid
occupation, living with a partner, smoking before and during pregnancy, maternal pre-pregnancy
BMI, gestational diabetes, parity, twin pregnancy, attending an antenatal course, birth in a BFH,
type of delivery, analgesia or anaesthesia in labour, intention to breastfeed, gestational age, birth
weight, timing of the first breastfeed, rooming-in, baby-led feeding, use of bottle and/or pacifier
during hospital stay. The results of the logistic regression models were used to obtain adjusted
breastfeeding rates at different ages, with 95% confidence intervals adjusted for the effect of the
cluster design.
Results
Table A1 in appendix shows the number of subjects enrolled and followed up to 12 months by LHA
in the early and late intervention groups and by round of data collection. The final database includes
5094 records of enrolled mother-baby dyads, including 107 twins (2%), 126 dyads less than the
intended overall sample size due to the failure of two LHAs, both in the late intervention group, to
participate in one of the data collection rounds. For the analysis at three months, 4704 dyads are
available, a loss of 7.7%; at six months, data are available on 4572 dyads, a further 2.8% loss; at 12
months, 4405 dyads completed the series of interviews, for a total loss to follow up of 13.5% (range
of 9% to 20% among LHAs, no significant differences by intervention group and by round of data
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collection), less than the 20% predicted when the sample size was calculated. A total of 281 eligible
mothers declined to be enrolled for various reasons; there were no significant differences between
participant and non-participant mothers except for nationality, the proportion of foreign women
being higher among the latter. Table 2 shows the characteristics of the mothers and infants included
in the analysis, by study group. The demographic characteristics of the sample were similar to
national averages in terms of age and education, while the percentage of women with a paid
employment was slightly higher.30 More women in the sample attended antenatal classes than do on
average throughout the country (44% vs. 35%).31 It is also worth noting that the rate of caesarean
delivery (27-29%) was well below the national average of 38%, although slightly fewer women had
term births (90-92% vs. 93%). There were several statistically significant differences between early
and late intervention groups; these differences were accounted for in the multivariate analysis. The
significantly better perinatal care practices reported by mothers in the early intervention group are
probably due to the higher percentage of births in BFHs.
Table 2. Characteristics of the mothers and infants included in the analysis, by study group.
Early intervention Late intervention p-value
Mean (sd) age (years) 32 (5) 32 (5) 0.121
Mean (sd) education (years) 14 (4) 13 (4) <0.001
Employment: paid occupation 76% 78% 0.095
Italian 85% 85% 0.535
Living with the partner 97% 96% 0.004
Smoking before pregnancy 29% 27% 0.109
during pregnancy 11% 8% 0.003
Referred BMI <25 80% 79% 0.436
25-29.9 14% 15%
>=30 6% 6%
Gestational diabetes 7% 8% 0.021
Primiparae 57% 54% 0.053
Attendance to antenatal classes 44% 44% 0.716
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At least one session on BF 82% 87% 0.002
Delivery at term (38-41 weeks) 92% 90% 0.003
Caesarean section rate 27% 29% 0.058
Anaesthesia or analgesia during
labour/delivery (including C-section)
55% 60% <0.001
Mean (sd) birth weight (g) 3304 (443) 3283 (443) 0.092
Previous breastfeeding experience 41% 44% 0.126
Of which <6 months 31% 37% 0.034
6-12 months 45% 42%
13-24 months 20% 18%
>24 months 4% 3%
Intention to breastfeed current baby 99% 98% 0.126
exclusively for at least 6 m 82% 80% 0.184
Birth in a Baby Friendly Hospital 32% 27% <0.001
Baby latched on within 1 hour 61% 67% <0.001
Rooming-in (24h/day, all infants) 77% 80% 0.080
Baby-led BF (breastfed infants) 90% 89% 0.246
Baby used bottle (all infants) 20% 18% 0.001
Baby used pacifier (all infants) 19% 26% <0.001
Figures 2-6 show the crude rates of EBF at discharge (recall from birth) and at three and six months
(recall 7 days), and the crude rates of any breastfeeding at six and 12 months (recall 24 hours). By
the end of the project, almost 70% of infants were exclusively breastfed at discharge, with an
increasing trend between rounds 1 and 3 of data collection, and with great variation among sites
(range: 26% to 93%). Both the upward trend between the first and the third round of data collection,
and the variation among sites, are present at 3, 6 and 12 months, for both exclusive and any
breastfeeding. At the third round of data collection, the rates of EBF were fairly high at three
months (54% at round 3, range 36% to 66%), but dropped to 8% (range 1% to 23%) at six months.
These rates were lower than expected, even when considering the figures for the 24-hour recall:
10% (range 3% to 23%). At the end of the project, almost 38% of infants were continuing to
breastfeed at 12 months.
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Crude rates, however, cannot be used for comparisons, as this was not a randomised trial and
confounding has to be considered. Table 3 shows the adjusted rates of exclusive and any
breastfeeding at different ages and with different recall periods by intervention group and round of
data collection. Though there was a clear pattern of higher rates in the early intervention group,
there were no statistically significant differences between groups and rounds of data collection as
far as adjusted rates at discharge (not shown) are concerned. The lack of a statistically significant
difference between groups had already been noted at baseline,24 when it was in fact expected
because sites were paired by breastfeeding rates, and persisted through the second and third round
of data collection. Table 3 shows an upward trend of the adjusted rates of breastfeeding between
rounds of data collection, with the exception of EBF and ABF at six months in the early
intervention group. Yet none of the differences between and within groups is statistically
significant. The removal of twins from the dataset did not change the results.
Table 3. Adjusted rates (%) of exclusive (EBF) and any (ABF) breastfeeding at different ages and
with different recall periods by intervention group and round of data collection.
Breastfeeding
indicators
Early intervention group Late intervention group
Round n % (95% CI) n % (95% CI)
EBF at 3 m
(recall 24 h)
1 852 58.1 (52.1 – 64.1) 746 52.8 (47.3 – 58.4)
2 845 57.5 (54.4 – 60.7) 645 53.6 (45.7 – 61.6)
3 867 62.3 (59.8 – 64.7) 633 57.9 (53.8 – 62.1)
EBF at 3 m
(recall 7 d)
1 852 49.6 (43.5 – 55.7) 746 43.4 (38.3 – 48.5)
2 845 52.9 (48.7 – 57.2) 645 50.0 (41.5 – 58.4)
3 867 55.9 (52.3 – 59.4) 633 51.1 (47.5 – 54.6)
EBF at 6 m
(recall 24 h)
1 822 9.0 (6.2 – 11.9) 726 7.1 (3.9 – 10.2)
2 835 7.7 (5.4 – 9.9) 636 8.4 (4.7 – 12.2)
3 842 7.6 (4.9 – 10.3) 599 9.6 (7.2 – 12.1)
EBF at 6 m 1 822 5.5 (3.8 – 7.2) 726 5.3 (2.8 – 7.7)
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(recall 7 d) 2 835 5.6 (3.7 – 7.4) 636 6.7 (3.7 – 9.8)
3 842 5.4 (2.7 – 8.0) 599 7.6 (5.6 – 9.6)
ABF at 6 m
(recall 24 h)
1 822 67.6 (62.5 – 72.7) 726 62.4 (55.8 – 69.0)
2 835 66.7 (63.5 – 69.9) 636 63.4 (59.4 – 67.3)
3 842 69.0 (66.2 – 71.8) 599 65.4 (61.4 – 69.5)
ABF at 12 m
(recall 24 h)
1 777 32.4 (26.6 – 38.2) 683 28.6 (24.1 – 33.2)
2 820 34.9 (32.4 – 37.5) 611 30.8 (24.0 – 37.6)
3 817 36.2 (32.4 – 40.1) 592 34.9 (30.9 – 39.0)
As the periodic self-assessments had revealed that some of the study sites were making progress in
the implementation of the 7 Steps, while others were lagging behind, we carried out a comparison
by compliance with the intervention, in addition to the analysis by intention to treat. Table 4 shows
the same adjusted rates of breastfeeding of Table 3 after re-grouping the 18 LHAs by compliance
with the intervention. This comparison shows some statistically significant differences between
groups (EBF at three months in rounds 1 and 3, and ABF at six months in rounds 2 and 3) and
between rounds (EBF at three months between rounds 1 and 3 in the non-compliance group), but it
does not show an effect of the intervention. We repeated the same statistical analysis using staff
training to re-group the 18 LHAs into groups with higher and lower training coverage; results (not
shown but available on request) and interpretation did not change. It is interesting to note, however,
that, despite the apparent lack of effect of the intervention and despite similar adjusted rates of
initiation (between 65% and 72% in both groups), the LHAs in the compliance and higher training
coverage groups presented consistently higher rates of breastfeeding throughout the first year of
life. Once again, the removal of twins did not change the results.
Table 4. Adjusted rates (%) of exclusive (EBF) and any (ABF) breastfeeding at different ages and
with different recall periods by compliance with the intervention and round of data collection.
Breastfeeding Compliance group Non-compliance group
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indicators Round n % (95% CI) n % (95% CI)
EBF at 3 m
(recall 24 h)
1 978 60.6 (56.2 – 65.0)§ 620 47.6 (43.6 – 51.6)§*
2 979 58.4 (54.9 – 61.9) 511 51.0 (42.8 – 59.1)
3 993 63.5 (61.4 – 65.7)§ 507 54.5 (51.7 – 57.3)§*
EBF at 3 m
(recall 7 d)
1 978 51.1 (46.1 – 56.1)§ 620 39.7 (35.6 – 43.8)§*
2 979 53.9 (49.6 – 58.3) 511 47.3 (38.7 – 55.9)
3 993 56.8 (53.7 – 59.9)§ 507 48.1 (45.1 – 51.2)§*
EBF at 6 m
(recall 24 h)
1 947 9.8 (7.0 – 12.6) 601 5.6 (2.5 – 8.7)
2 956 8.3 (5.5 – 11.1) 515 7.5 (4.1 – 10.9)
3 951 9.4 (6.8 – 12.1) 490 6.5 (3.5 – 9.5)
EBF at 6 m
(recall 7 d)
1 947 6.3 (4.6 – 7.9) 601 4.2 (1.7 – 6.8)
2 956 6.4 (4.0 – 8.8) 515 5.6 (3.1 – 8.1)
3 951 7.0 (4.1 – 9.9) 490 4.7 (2.6 – 6.8)
ABF at 6 m
(recall 24 h)
1 947 68.9 (64.4 – 73.3) 601 59.1 (53.2 – 65.0)
2 956 67.4 (65.2 – 69.6)§ 515 61.1 (57.3 – 65.0)§
3 951 70.3 (67.6 – 73.1)§ 490 62.1 (59.6 – 64.6)§
ABF at 12 m
(recall 24 h)
1 890 33.5 (28.5 – 38.5) 570 26.2 (21.7 – 30.7)
2 931 35.3 (32.2 – 38.4) 500 29.3 (22.3 – 36.3)
3 930 37.6 (34.3 – 40.9) 479 32.1 (28.0 – 36.1)
§ p<0.05 between groups; * p<0.05 between rounds.
We carried out also a logistic regression analysis including all the variables used to adjust the rates
of breastfeeding, plus the rates of EBF at discharge (recall from birth). Tables A2 and A3 in
appendix show the adjusted rates of breastfeeding and the odd ratios, with their respective 95%
confidence intervals, by early and late intervention and by compliance and non-compliance,
respectively, and by round of data collection, using the rates of the late intervention and non-
compliance groups at round 1 as comparators. Using this logistic regression model, a small number
of odd ratios result in statistically significant differences. These differences, however, do not
indicate a clear association between the BFCI intervention, or compliance with it, and increased
rates of breastfeeding.
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Finally, we analysed the answers mothers gave at the 12-month interview when asked if they had
had problems with breastfeeding, where they had looked for help, and whether they thought that
those providing help had solved their problems or not. Overall, the 5094 mothers reported 1082
problems, mainly breast and nipple complaints (39%), not enough milk (32%) and difficulties
latching the baby on (20%), with no statistically significant differences between groups and rounds
of data collection. There were no differences also in the percentage of mothers who sought help for
these problems either. Some relevant statistically significant differences (p<0.05) were found when
mothers were asked to evaluate on a Likert scale the help received by level of usefulness in solving
their problems. Mothers in the early intervention group classified this help as useful or very useful
in 72%, 78% and 82% of cases in rounds 1, 2 and 3, respectively, compared to 63%, 72% and 73%
of mothers in the late intervention group.
Discussion
The protection, promotion and support of breastfeeding in a community is a complex, challenging
and multisectoral set of interventions that need synergistic engagement by a number of different
actors.32 Our non-randomised controlled study measured the effect of the BFCI on the breastfeeding
rates of a community, not only among infants served by health services. It failed to demonstrate a
statistically significant effect, in particular on the rates of EBF at six months, the primary outcome
under scrutiny. Failure to demonstrate an effect does not necessarily mean that there was no effect.
As shown by our figures and tables, the rates of breastfeeding went up during the project, which
lasted approximately four years. These increases, however, occurred in the LHAs of both groups,
whether they were early or late implementers of the 7 Steps, whether they complied with them to a
greater or lesser extent, and whether they achieved a higher or lower training coverage. None of the
differences was statistically significant. There are many possible explanations for this.
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First, the study may not have had the power to identify small differences as significant. The sample
size, in fact, was established on the assumption that the baseline rate of EBF at six months would be
around 25% and that we would be able to detect an increase of 10%. To our surprise, the baseline
rate of EBF at six months was around 10%,24 and it went up by only 1-2% in four years. The
initially presumed 25% rate was probably the result of inaccurate local statistics. Also, there was a
large drop in EBF between three and six months, most likely due to recommendations by the
majority of paediatrician to introduce solids between four and six months, given the lack of
significant differences by maternal occupation and return to work. Second, the lag time between the
implementation of the 7 Steps and their effects on the rates of breastfeeding may be longer than the
duration of the project. So far, six LHAs, all in the early intervention group, were accredited as
Baby Friendly after passing three phases of external evaluation: two in 2012, close to the end of the
research project, three in 2014 and one in 2015, two and three years after the end of the research
project; other LHAs are still working toward accreditation. Third, the 18 LHAs that volunteered to
participate in the study were already highly committed to the promotion of breastfeeding, compared
to other LHAs nationwide, as shown by the presence of accredited BFHs in one third of the study
areas. The implementation of the 7 Steps might have occurred at a time when breastfeeding was
already on the rise. Lastly, the baseline rates of breastfeeding at 3, 6 and 12 months of our 18 LHAs
were higher than those commonly reported in Italy,8,33 partly due to the above mentioned
commitment to the promotion of breastfeeding, partly because they are located in northern and
central Italy, where rates of breastfeeding are usually higher than in southern regions.34 It may be
harder to increase breastfeeding rates starting from a higher than from a lower level.
A comparison with the trends in the rates of breastfeeding in the same regions where the 18
participating LHAs are located, and during approximately the same period, may help understand if
the small increases reported were associated with BFCI activities or not. This is possible only for
three regions: Lombardia (5 out of its 15 LHAs were included in the BFCI project), Emilia
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Romagna (3 of 11), and Friuli Venezia Giulia (2 of 6). In Lombardia, the rate of EBF at the first
immunization (2-3 months of age) was 38% in 2006 and 47% in 2012; at the second (around five
months of age), it went up from 19% to 27% in the same period.35 In Emilia Romagna, the rates of
EBF at the first and second immunization went up from 47% to 48% and down from 41% to 30%,
respectively, between 2008 and 2011.36 In Friuli Venezia Giulia, the rate of EBF at the second
immunization was 38% in 2004,37 and it went down to 34% in 2011.
38 Our data, however, are very
accurate; the age of the infant, for example, is the exact age plus or minus a week. Instead, the data
from the three regions above refer to infants whose ages may be within a range of one or two
months. They may also be less standardized, and perhaps biased, because they are gathered by
professionals in their own LHA, while our data were collected by independent interviewers. The
samples used in routine surveillance systems may also be less representative than in our sample.
More recently, the National Institute of Statistics published a preliminary report of a survey on
pregnancy, childbirth and breastfeeding carried out in 2013 on a nationally representative sample.39
The results, which are not yet broken down by region, show that between 2005 and 2013 the
initiation of breastfeeding went up from 81.4% to 85.5%, while the median duration increased from
7.3 to 8.3 months, with small differences between macroregions. The survey indicates that there is a
general upward trend, but unfortunately it does not allow to gauge the effect of the BFCI, because it
does not report trends in the rates of EBF.
Our study has some limitations. As it was impossible to randomise the 18 LHAs, the results may be
biased by some residual confounding, despite our efforts to adjust data for well-known confounders
before any comparison between groups. As already mentioned, our study might not have the power
to identify small statistically significant improvements in breastfeeding rates. In addition, it may
have been too short: the effects of the BFCI may become evident over a longer period. Finally, our
study was carried out in a real-life situation. This means that the actual implementation of the
intervention did not necessarily follow the timing and mode proposed by the research protocol, and
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was instead adapted to each reality and tailored to the local situation.21 For example, the
development and approval of a written policy (Step 1) may take different amounts of time in
different LHAs, because of factors such as the continuity and commitment of decision makers, as
well as the complexity of the organization. Some of the 18 LHAs are small and compact, whereas
others are large and located in cities like Rome, Milan and Bologna, where the number of actors is
much higher. This has a bearing on the implementation of Step 2; it is easier to conduct courses
where the number of health professionals is small and stable, while it is much more difficult to
achieve a high coverage with large numbers of professionals and a high turnover. Similar
considerations are relevant for the other steps, and particularly for Step 6, the provision of a
welcoming atmosphere for breastfeeding families, and Step 7, the promotion of co-operation
between healthcare staff, breastfeeding support groups and the local community, which are closely
related. With such a heterogeneous and continuously changing group of study units, it was difficult
to decide what to compare with what, making the interpretation of results very problematic.
To conclude, the BFCI is a complex intervention carried out in socially and geographically different
areas.22 Implementing the 7 Steps requires years of hard work geared toward sustainable changes by
policy and decision makers, all categories of health professionals, public and private health
organizations, mother-to-mother support groups, volunteer organizations and local administrators.
The challenge is to modify the practices of health care professionals and achieve organizational
changes, an objective that is hard to achieve even in the BFHI,32,40 a much less complex initiative,
but also to shape and activate mutually supportive networks. It was encouraging to see all the
coordinated efforts being made in a coordinated way in the 18 LHAs that volunteered to participate
in this project. But complex interventions are not only difficult to implement, it is difficult to assess
their effects in real life.41 The design and methods used in this study are far from perfect, but it
would be difficult to measure the effect of the BFCI, if any, using the rigorous methods of a
randomized controlled trial. The project is already bringing about changes in the way breastfeeding
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is protected, promoted and supported in the 18 LHAs. This study does not allow to determine that
the BFCI is effective nor that it is ineffective, but it has paved the way for better practices in the 18
LHAs and hopefully in other regions of Italy and in other countries.
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Acknowledgements
This work was supported by a financial contribution from the Institute for Maternal and Child
Health IRCCS Burlo Garofolo, Trieste, Italy (research grant n. 32/08), and by funds made available
by the Italian Committee for UNICEF and by each of the participating LHAs for local activities.
The study could not have been carried out without the commitment of dozens of dedicated health
professionals in the 18 study sites, too many to name individually, and the dedication of the
interviewers based at the School of Management and Health in Pisa, Italy. Special thanks to
Leonardo Speri, former coordinator of the BFHI/BFCI Task Force of the Italian Committee for
UNICEF, who strongly supported the idea of setting up this research project.
The study was approved by the Ethics Committees of the Institute for Maternal and Child Health
IRCCS Burlo Garofolo in Trieste and of the 18 participating Local Health Authorities: Bassano del
Grappa, Biella, Bologna, Cesena, Forlì, Friuli Occidentale, Mantova, Marche, Massa Carrara,
Milano, Milano 1, Milano 2, Oristano, Roma B, Sondrio, Trieste, Verbania and Verona.
The following are members of the BFCI Study Group, in addition to the main authors: Alessandra
Knowles, Paola Pani, Claudia Carletti (Institute for Maternal and Child Health IRCCS Burlo
Garofolo, Trieste); Annacatia Miola, Stefania Battocchio, Paola Dal Zotto (Local Health Authority,
Bassano del Grappa); Emiliana Mosca, Angelo Penna, Antonella Tedesco (Local Health Authority,
Biella); Franco Garofalo, Anna Perona (Department of Paediatrics, Biella Hospital); Paola Lenzi,
Marilina Colombo, Cledemaria Garavini (Local Health Authority, Bologna); Massimo Farneti,
Marcella Lombardi (Local Health Authority, Cesena); Anna Maria Baldoni, Laura Borghesi, Paola
Dalla Casa, Enrico Marchiani, Claudia Zoli (Local Health Authority, Forlì); Federica Braida,
Oriana Raminelli, Anna Furlan (Local Health Authority, Pordenone); Fiorella Talassi, Loretta
Grossi, Gabriele Gianella, Paola Mussini (Local Health Authority, Mantova); Rita Gatti, Grazia
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Pompilio (Maternal and Child Health Centre, Loreto); Marco Morbidoni (Department of
Epidemiology, Ancona); Mauro Tiriduzzi, Nadia Liberatore, Susi Campanari, Paola Catena
(Department of Obstetrics and Gynaecology, Osimo Hospital); Laura Polenta, Roberta Freddara
(Salesi Hospital, Ancona); Fabiola Salvetti, Cinzia Luzi, Romana Prosperi Porta (Department of
Pediatrics, Massa Carrara Hospital); Rita Mascheroni, Miriam Lelli, Graziella Cattaneo, Raffaella
Gennaretti, Antonia Tomaselli (Local Health Authority, Milan); Maria Elena Pirola, Domenico
Arensi, Giovanni Beghi, Gigliola Ronchi, Piera Ceresa, Silvano Santucci (Local Health Authority,
Milan 1); Luigi Acerbi, Maura Franzetti, Roberto Lucchini, Giuseppina De Gasperi (Local Health
Authority, Milan 2); Maria Antonietta Grimaldi (Local Health Authority, Oristano); Patrizia
Auriemma, Patrizia Proietti, Elisa Lazzaro (Local Health Authority, Rome B); Eloisa Del Curto,
Patrizia Sossi, Livia Tabacchi, Paola Abbiati (Local Health Authority, Sondrio); Maria Vittoria Sola
(Local Health Authority, Trieste); Andrea Guala, Raffaella Visentin, Luigina Boscardini, Elena
Ferzetti, Laura Cantalupi (Local Health Authority, Verbano-Cusio-Ossola); Emanuela Battisti,
Daniela Dainese, Francesca Lazzari, Elisa Pastorelli (Local Health Authority, Verona).
Contributors: AC designed and coordinated the study, participated in data analysis and
interpretation, and drafted and revised the paper. He acts as guarantor. MEB and EMC pilot tested
and developed the BFCI tools used in the study, were in charge of monitoring the implementation
of BFCI activities by gathering and analysing periodic reports from the study sites, and contributed
to the interpretation of results. AM and LCES centralized and checked all the data gathered in the
three rounds of data collection in a continuous feedback with the study sites, were in charge of
making the datasets ready for analysis, and contributed to the interpretation of results. AMM was
responsible for all the CATI interviews and prepared the relative datasets. MM carried out the
statistical analysis. All the members of the BFCI Study group participated in the implementation of
BFCI activities and in the collection of data for the first interview. All co-authors, including the
members of the BFCI Study Group, approved the final version of the manuscript.
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The manuscript’s guarantor affirms that this manuscript is an honest, accurate, and transparent
account of the study being reported; that no important aspects of the study have been omitted; and
that any discrepancies from the study as planned (and, if relevant, registered) have been explained.
Data sharing: the full dataset is available on reasonable request from the corresponding author at
[email protected]. Consent for data sharing was not obtained, but the presented data
are anonymised and risk of identification is low.
Competing interests: none declared.
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26 Bland RM, Rollins NC, Solarsh G, et al. Maternal recall of exclusive breast feeding duration.
Arch Dis Child 2003;88:778-83
27 World Health Organization. Indicators for assessing infant and young child feeding practices:
Part 1 definitions. WHO, Geneva, 2009
28 World Health Organization. Indicators for assessing infant and young child feeding practices:
Part 2 measurement. WHO, Geneva, 2010
29 UNICEF, WHO. Baby Friendly Hospital Initiative. Revised, updated and expanded for
integrated care. Section 4: hospital self-appraisal and monitoring. UNICEF, New York, 2009
30 ISTAT. Essere madri in Italia. ISTAT, Rome, 2007
31 ISTAT. Natalità e fecondità della popolazione residente nel 2011. ISTAT, Rome, 2012
32 Semenic S, Childerhose JE, Lauziere J, et al. Barriers, facilitators, and recommendations related
to implementing the Baby-Friendly Initiative (BFI): an integrative review. J Hum Lact
2012;28:317-34
33 Giovannini M, Riva E, Banderali G, et al. Feeding practices of infants through the first year of
life in Italy. Acta Paediatr 2004;93:492-7
34 Giovannini M, Banderali G, Agostoni C, et al. Epidemiology of breastfeeding in Italy. Acta
Paediatr Suppl 1999;88:19-22
35 Pirola ME, Bettinelli ME, Bonfanti M, et al. Prevalenza, esclusività e durata dell'allattamento al
seno in Regione Lombardia. Regione Lombardia, Milano,
36 Marchetti F. Prevalenza dell'allattamento al seno e altri interventi preventivi in Emilia Romagna.
Medico e Bambino 2013;32:223-5
37 Cattaneo A, Giuliani C. Breastfeeding in Friuli Venezia Giulia. Eur J Public Health 2006;16:111
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38 Cuoghi C, Di Mario S, Borgini B, et al. Prevalenza dell'allattamento al seno e altri interventi
preventivi in Emilia-Romagna. Regione Emilia Romagna, Bologna, 2011
39 ISTAT. Gravidanza, parto e allattamento al seno, anno 2013. ISTAT, Rome, 2014
40 Schmied V, Gribble K, Sheehan A, et al. Ten steps or climbing a mountain: a study of Australian
health professionals' perceptions of implementing the baby friendly health initiative to protect,
promote and support breastfeeding. BMC Health Serv Res 2011;11:208
41 Campbell NC, Murray E, Darbyshire J, et al. Designing and evaluating complex interventions to
improve health care. BMJ 2007;334:455-9
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Figures’ titles
Figure 1. A sketch of the study design.
Figure 2. Rates of exclusive breastfeeding at discharge (recall from birth) by site, group and round
of data collection.
Figure 3. Rates of exclusive breastfeeding at three months (recall 7 days) by site, group and round
of data collection.
Figure 4. Rates of exclusive breastfeeding at six months (recall 7 days) by site, group and round of
data collection.
Figure 5. Rates of any breastfeeding at six months (recall 24 hours) by site, group and round of data
collection.
Figure 6. Rates of any breastfeeding at 12 months (recall 24 hours) by site, group and round of data
collection.
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Figure 1. A sketch of the study design. 264x200mm (96 x 96 DPI)
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Figure 2. Rates of exclusive breastfeeding at discharge (recall from birth) by site, group and round of data collection.
169x112mm (96 x 96 DPI)
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Figure 3. Rates of exclusive breastfeeding at three months (recall 7 days) by site, group and round of data collection.
169x112mm (96 x 96 DPI)
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Figure 4. Rates of exclusive breastfeeding at six months (recall 7 days) by site, group and round of data collection.
169x112mm (96 x 96 DPI)
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Figure 5. Rates of any breastfeeding at six months (recall 24 hours) by site, group and round of data collection.
169x112mm (96 x 96 DPI)
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Figure 6. Rates of any breastfeeding at 12 months (recall 24 hours) by site, group and round of data collection.
169x112mm (96 x 96 DPI)
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Appendix
Table A1. Subjects enrolled and followed up to 12 months by LHA in the early and late intervention groups and by round of data collection
Group LHA Assigned
sample
size
Round 1
(01/09/09-31/03/10)
Round 2
(01/09/10-31/03/11)
Round 3
(01/09/11-31/03/12)
Total
Enrolled F-up
12 m
Loss Enrolled F-up
12 m
Loss Enrolled F-up
12 m
Loss Enrolled F-up
12 m
Loss
Early
interv
ention
5 124 124 103 17% 126 115 9% 129 116 10% 379 334 12%
6 48 48 38 21% 47 43 9% 47 42 11% 142 123 13%
8 54 56 52 7% 61 55 10% 58 50 14% 175 157 10%
9 121 122 99 19% 122 93 23% 123 105 15% 367 297 19%
10 109 109 91 17% 112 105 5% 113 99 12% 334 295 12%
14 122 120 96 20% 117 102 13% 122 109 11% 359 307 14%
15 126 126 117 7% 127 111 13% 126 107 15% 379 335 12%
16 134 134 121 10% 135 122 10% 134 119 11% 403 362 10%
18 103 103 81 21% 103 94 9% 103 89 14% 309 264 15%
Total 942 942 798 15% 949 840 11% 955 836 12% 2846 2474 13%
Late in
tervention
1 136 139 117 16% 142 125 12% 140 122 13% 421 364 14%
2 85 94 77 18% 101 92 9% 100 88 12% 295 257 13%
3 50 51 37 27% 49 42 14% 47 40 15% 147 119 19%
4 143 147 131 11% 142 133 6% - - - 289 264 9%
7 115 129 101 22% - - - 130 118 9% 259 219 15%
11 62 61 54 11% 61 49 20% 62 53 15% 184 156 15%
12 68 68 56 18% 67 52 22% 69 55 20% 204 163 20%
13 43 53 50 6% 53 43 19% 51 43 16% 157 136 13%
17 97 97 89 8% 98 80 18% 97 84 13% 292 253 13%
Total 799 839 712 15% 713 616 14% 696 603 13% 2248 1931 14%
Grand total 1741 1781 1510 15% 1662 1456 12% 1651 1439 13% 5094 4405 14%
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Table A2. Adjusted rates of breastfeeding (AR) and odd ratios (OR), with their respective 95% confidence intervals (95% CI), by early and late
intervention groups and round of data collection. Late intervention group at round 1 of data collection as comparator. Statistically significand
differences (p<0.05) in bold.
Breastfeeding
indicators
Round of
data
collection
Early intervention group Late intervention group
AR
(%)
95% CI
(%)
OR 95% CI AR
(%)
95% CI
(%)
OR 95% CI
EBF at
discharge
(recall 24 h)
1 87.2 83.4-91.1 1.03 0.62-1.70 86.9 82.7-91.1 1 -
2 88.4 84.8-92.1 1.15 0.69-1.91 85.6 80.9-90.2 0.89 0.61-1.31
3 87.4 83.5-91.3 1.04 0.63-1.74 86.4 82.0-90.8 0.96 0.65-1.40
EBF at
discharge
(from birth)
1 72.2 62.0-82.5 1.36 0.66-2.76 65.7 54.0-77.5 1 -
2 73.6 63.6-83.6 1.45 0.71-2.96 70.2 59.1-81.2 1.23 0.90-1.67
3 73.1 63.0-83.2 1.41 0.69-2.89 73.5 63.3-83.8 1.45 1.05-1.99
EBF at 3
months
(recall 24 h)
1 57.7 52.6-62.8 1.13 0.86-1.49 54.7 49.2-60.2 1 -
2 57.1 51.9-62.3 1.10 0.83-1.45 54.5 48.8-60.2 0.99 0.79-1.25
3 61.8 56.8-66.9 1.34 1.01-1.77 58.1 52.4-63.7 1.15 0.90-1.46
EBF at 3
months
(recall 7 d)
1 48.6 42.9-54.3 1.13 0.82-1.55 45.6 39.7-51.6 1 -
2 52.0 46.3-57.7 1.29 0.94-1.78 51.4 45.2-57.6 1.26 1.00-1.58
3 54.9 49.2-60.6 1.45 1.05-2.00 51.4 45.1-57.6 1.26 0.99-1.59
EBF at 6
months
(recall 24 h)
1 8.6 5.6-11.7 1.17 0.67-2.05 7.4 4.6-10.3 1 -
2 7.3 4.6-9.9 0.98 0.55-1.71 8.3 5.1-11.5 1.13 0.77-1.65
3 7.3 4.6-9.9 0.97 0.55-1.71 9.3 5.8-12.8 1.27 0.86-1.87
EBF at 6
months
(recall 7 d)
1 5.2 3.0-7.3 0.93 0.50-1.73 5.5 3.2-7.9 1 -
2 5.2 3.1-7.3 0.93 0.50-1.72 6.7 3.9-9.5 1.22 0.80-1.84
3 5.0 2.9-7.1 0.90 0.49-1.66 7.1 4.1-10.0 1.30 0.85-1.98
ABF at 6
months
(recall 24 h)
1 67.8 63.1-72.6 1.18 0.94-1.48 64.1 58.9-69.3 1 -
2 66.9 62.1-71.7 1.13 0.90-1.42 63.7 58.3-69.1 0.98 0.77-1.24
3 69.1 64.4-73.8 1.25 0.99-1.57 66.5 61.2-71.9 1.11 0.87-1.42
ABF at 12
months
(recall 24 h)
1 32.0 27.2-36.8 1.12 0.86-1.45 29.7 24.8-34.5 1 -
2 34.8 29.9-39.6 1.26 0.98-1.63 31.1 26.0-36.2 1.07 0.84-1.37
3 35.9 31.0-40.9 1.33 1.03-1.72 34.8 29.4-40.1 1.26 0.98-1.62
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Table A3. Adjusted rates of breastfeeding (AR) and odd ratios (OR), with their respective 95% confidence intervals (95% CI), by compliance with the
intervention and round of data collection. Non-compliance group at round 1 of data collection as comparator. Statistically significand differences
(p<0.05) in bold.
Breastfeeding
indicators
Round of
data
collection
Compliance group Non-compliance group
AR
(%)
95% CI
(%)
OR 95% CI AR
(%)
95% CI
(%)
OR 95% CI
EBF at
discharge
(recall 24 h)
1 87.2 83.5-90.8 1.02 0.60-1.75 86.9 82.1-91.8 1 -
2 86.9 83.2-90.6 0.99 0.58-1.70 88.0 83.3-92.7 1.10 0.71-1.71
3 87.9 84.4-91.4 1.09 0.64-1.88 84.9 79.5-90.3 0.85 0.55-1.30
EBF at
discharge
(from birth)
1 70.3 60.4-80.2 1.16 0.53-2.50 67.2 53.9-80.5 1 -
2 69.6 59.6-79.6 1.12 0.52-2.41 76.2 64.9-87.4 1.56 1.09-2.23
3 72.2 62.7-81.7 1.27 0.59-2.75 74.5 62.9-86.0 1.42 1.00-2.04
EBF at 3
months
(recall 24 h)
1 60.5 56.9-64.2 1.64 1.26-2.13 48.3 43.3-53.4 1 -
2 58.3 54.6-62.0 1.49 1.15-1.93 51.4 46.1-56.7 1.13 0.88-1.46
3 63.4 59.9-67.0 1.85 1.43-2.41 54.6 49.4-59.8 1.28 0.99-1.67
EBF at 3
months
(recall 7 d)
1 50.4 45.7-55.1 1.42 1.03-1.95 41.8 35.8-47.8 1 -
2 53.4 48.7-58.0 1.60 1.16-2.19 48.8 42.4-55.2 1.33 1.03-1.72
3 56.2 51.6-60.9 1.79 1.30-2.46 48.5 42.1-54.8 1.31 1.01-1.71
EBF at 6
months
(recall 24 h)
1 9.6 6.6-12.5 1.67 0.93-3.01 5.9 3.3-8.6 1 -
2 8.1 5.5-10.6 1.38 0.77-2.49 7.7 4.3-11.0 1.31 0.83-2.08
3 9.2 6.3-12.0 1.60 0.89-2.88 6.4 3.5-9.3 1.08 0.66-1.76
EBF at 6
months
(recall 7 d)
1 6.1 3.8-8.3 1.39 0.72-2.67 4.4 2.2-6.7 1 -
2 6.1 3.8-8.3 1.39 0.73-2.67 5.8 2.9-8.7 1.32 0.80-2.19
3 6.7 4.3-9.2 1.55 0.81-2.98 4.5 2.1-6.8 1.01 0.59-1.73
ABF at 6
months
(recall 24 h)
1 68.7 64.5-72.9 1.40 1.07-1.84 61.0 55.4-66.6 1 -
2 67.3 63.0-71.5 1.31 1.01-1.71 61.7 55.9-67.5 1.03 0.79-1.34
3 70.1 66.0-74.3 1.50 1.15-1.97 64.0 58.4-69.6 1.14 0.87-1.48
ABF at 12
months
(recall 24 h)
1 33.0 28.6-37.4 1.31 0.97-1.76 27.3 22.2-32.5 1 -
2 35.0 30.5-39.4 1.43 1.07-1.92 29.8 24.3-35.4 1.13 0.86-1.50
3 37.2 32.6-41.7 1.57 1.17-2.11 32.5 26.9-38.2 1.28 0.96-1.71
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The effectiveness of the Baby Friendly Community Initiative
in Italy: a non-randomised controlled study
Journal: BMJ Open
Manuscript ID bmjopen-2015-010232.R1
Article Type: Research
Date Submitted by the Author: 04-Feb-2016
Complete List of Authors: Cattaneo, Adriano; Institute for Maternal and Child Health IRCCS Burlo Garofolo, Health Services Research and International Health Bettinelli, Maria; Local Health Authority, Maternal and Child Health Unit, Department of Primary Care Chapin, Elise; Italian Committee for UNICEF, Baby Friendly Initiatives Macaluso, Anna; Institute for Maternal and Child Health IRCCS Burlo Garofolo, Health Services Research and International Health Córdova do Espírito Santo, Lílian; National Council for Technological and Scientific Development Murante, Anna Maria; Scuola Superiore Sant'Anna, Istituto di MAnagement - Laboratorio Management e sanità Montico, Marcella; Institute for Maternal and Child Health IRCCS Burlo Garofolo, Epidemiology and Biostatistics
<b>Primary Subject Heading</b>:
Health services research
Secondary Subject Heading: Paediatrics
Keywords: Breastfeeding, Baby-Friendly Initiatives, Italy
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1
The effectiveness of the Baby Friendly Community Initiative in Italy: a non-randomised controlled
study
Running title: Baby-Friendly Community Initiative
Adriano Cattaneo, Maria Enrica Bettinelli, Elise Chapin, Anna Macaluso, Lílian Córdova do
Espírito Santo, Anna Maria Murante, Marcella Montico, on behalf of the BFCI Study Group
Health Services Research and International Health, Institute for Maternal and Child Health IRCCS
Burlo Garofolo, Via dell’Istria 65/1, 34137 Trieste, Italy (Adriano Cattaneo, Anna Macaluso),
Maternal and Child Health Unit, Department of Primary Care, Local Health Authority, 20122
Milan, Italy (Maria Enrica Bettinelli), Baby Friendly Initiatives, Italian Committee for UNICEF,
00185 Rome, Italy (Elise M. Chapin), Grant recipient, National Council for Technological and
Scientific Development, Porto Alegre, Brazil (Lílian Córdova do Espírito Santo), Management and
Health Laboratory, Institute of Management, Scuola Superiore Sant’Anna, 56127 Pisa, Italy (Anna
Maria Murante), Epidemiology and Biostatistics, Institute for Maternal and Child Health IRCCS
Burlo Garofolo, 34137 Trieste, Italy (Marcella Montico).
Correspondence to: [email protected]; mobile +393206797647
Keywords: breastfeeding, Baby Friendly Initiatives, Italy
Word count (text): 4553
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Abstract
Objective. To assess the effectiveness of the Baby Friendly Community Initiative (BFCI) on
exclusive breastfeeding to six months.
Design. Controlled, non-randomised trial.
Setting. 18 Local Health Authorities in 9 regions of Italy.
Participants. 5094 mother/infant dyads in three cohorts followed-up to 12 months after birth in three
rounds of data collection: at baseline, after implementation of the intervention in the early
intervention group, and after implementation in the late intervention group. 689 (14%) dyads did
not complete the study.
Intervention. Implementation of the 7 Steps of the BFCI.
Main outcome measures. The rate of exclusive breastfeeding at 6 months was the primary outcome;
breastfeeding at discharge, 3 and 12 months were also measured.
Results. The crude rates of exclusive breastfeeding at discharge, 3 and 6 months, and of any
breastfeeding at 6 and 12 months increased at each round of data collection after baseline in both
the early and late intervention groups. At the end of the project, 10% of infants were exclusively
breastfed at 6 months and 38% were continuing to breastfeed at 12 months. However, the
comparison by adjusted rates and logistic regression failed to show statistically significant
differences between groups and rounds of data collection in the intention-to-treat analysis, but also
when compliance with the intervention and training coverage were taken into account.
Conclusions. The study failed to demonstrate an effect of the BFCI on the rates of breastfeeding.
This may be due to, among other factors, to the time needed to observe an effect on breastfeeding
following this complex intervention.
Word count: 254
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Strengths and limitations of this study
• Implementation of a complex multisectoral intervention for the protection, promotion and
support of breastfeeding, with synergistic engagement of many different actors.
• Controlled, though non-randomised, trial with possible effect measured in three rounds of
data collection, at baseline and before and after a phased implementation of the intervention.
• Rates of breastfeeding compared between groups of local health authorities by intention to
treat, compliance with the intervention and training coverage.
• Rates of breastfeeding increased overall during the four years of the study, but this may not
have had the power to identify small differences as significant.
• The effects of a complex intervention such as the Baby Friendly Community Initiative may
need more than the four years of the study to be observed.
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Introduction
The Baby Friendly Hospital Initiative (BFHI) is an evidence-based effective intervention that
contributes to increasing the initiation, exclusivity and duration of breastfeeding.1,2 Alone, however,
it cannot achieve the goals recommended by WHO, UNICEF and many national and professional
policies, i.e. exclusive breastfeeding (EBF) for six months and continued breastfeeding, with
adequate complementary foods, up to two years and beyond.3-6 Worldwide, rates of EBF to 6
months fall short of those recommended;7-9 interventions at the community level, in addition to the
hospital-based ones, are needed to improve them.10 Several community interventions, such as
primary-care-based educational programmes,11,12 competent professional support at home or in
health facilities,13 home visits by trained professionals,
14 home-based peer counselling,
15 or the
involvement of fathers,16,17 have been shown to be effective. In some countries, these interventions
have been integrated into Baby Friendly Community Initiatives (BFCI),18-20 generally considered as
an appropriate framework.21
The Italian Committee for UNICEF, which promotes and coordinates the BFHI in Italy, established
a working group to adapt and develop the BFCI for the national health system, in collaboration with
the Local Health Authority (LHA) of Milan, where it was initially piloted and later launched in
2007. The BFCI is based on the Seven Point Plan used in the UK and New Zealand, and includes
tools for planning, implementation, monitoring and evaluation described in a companion paper.22
Briefly, the 7 Steps of the BFCI (Table 1) are supposed to be implemented in all the non-hospital-
based health facilities of a LHA. These include health centres, mother and child health clinics,
family health centres, public and private medical, obstetric and paediatric practices, day care
centres, and, where present, public pharmacies. All the health and social workers of these facilities
have to be trained, in courses of different duration, to implement a policy previously developed by a
multidisciplinary team and approved by the LHA management. Health professionals are trained to
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help breastfeeding as well as formula-feeding mothers when and where they ask for support.
Moreover, by implementing Step 6, the LHA is required to create breastfeeding-friendly
environments not only in its premises and facilities, but also in other community and public places.
So called “baby pit stops” are created in public locations or businesses (shops, libraries, pharmacies,
etc.) where nursing mother can feel welcome. These places are free, do not require any purchase,
and become part of a network promoted by UNICEF Italy, with a periodic review by a consumers’
group or volunteers. Other initiatives included in this step are breastfeeding-friendly day care and
workplaces which are designed so that breastfeeding can once again be considered an act that can
be done in public. The day care centres have guidelines for the use of mother’s milk and welcome
breastfeeding mothers who want to feed their children when they drop them off or pick them up.
Step 7 focuses on networking with other services and mother-to-mother and peer support groups
that are not part of the health system. In addition to these groups, support may be offered through a
breastfeeding helpline, local health clinics, hospitals, or baby-friendly physicians’ offices, or
breastfeeding-friendly pharmacies (BFF). The BFF is a separate programme that requires all staff to
complete a 15-hour course, to promote breastfeeding as the norm, to keep breastmilk substitutes,
bottles and teats behind the counter with prescription drugs, to sell them only upon specific request,
and to abide, like all health facilities and professionals in the LHA, by the International Code of
Marketing of Breast-Milk Substitutes.
Table 1. The Seven Steps of the Baby Friendly Community Initiative
1. Have a written breastfeeding policy that is routinely communicated to all staff.
2. Train all staff to implement the breastfeeding policy.
3. Inform all pregnant women and their families about the benefits and management of
breastfeeding.
4. Support mothers to initiate and sustain breastfeeding.
5. Encourage exclusive breastfeeding up to 6 months of age, the introduction of appropriate
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complementary foods after 6 months, and continued breastfeeding.
6. Provide a welcoming atmosphere for breastfeeding families.
7. Promote cooperation between health care staff, breastfeeding support groups, and the local
community.
In 2009, 18 LHAs, which had expressed an interest in the BFCI, accepted the invitation from the
Italian Committee for UNICEF of working towards BFCI accreditation. This was an opportunity to
set up a research project to look at the effectiveness of the BFCI in terms of rates and duration of
EBF to six months, a recognized research priority.23 The methods and some baseline data of this
project have already been reported in a second companion paper.24 This third paper reports the final
results.
Methods
The methods of this research project have already been described.24 Briefly, this controlled trial
involved 18 LHAs in 9 regions of northern and central Italy. Some of these LHAs, however, had
already started implementing BFCI activities before the study was designed: Milan because it had a
leading role in developing the materials and tools and pilot testing them; others because they had
been part of the working group that adapted the BFCI for Italy, or had previously worked on
developing draft policies, or had conducted some limited staff training, especially where there was a
Baby Friendly Hospital (BFH). For these reasons, it was impossible to randomize the 18 LHAs into
intervention and control groups. It was instead decided to implement the 7 Steps in a phased way,
first in an early intervention group of LHAs that had already implemented some BFCI activities
(LHAs 5, 6, 8, 9, 10, 14, 15, 16, 18), then, after about 12 months, in the remaining ones (LHAs 1, 2,
3, 4, 7, 11, 12, 13, 17). Assignment to the early or late intervention group was preceded by pairing
LHAs based on reported rates of EBF at around 5 months of age, size of the population, and setting
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and population density (i.e. whether the LHA was mostly urban or rural). Figure 1 shows the study
design and the sample size at each round of data collection, at baseline, after implementation of
activities in the early intervention group, and after implementation in the late intervention group.
The rate of EBF at 6 months was the primary outcome of the study. To compare these rates between
groups and within them over time, data were gathered in three rounds. At each round of data
collection, starting in the fall of 2009, cohorts of infants were followed from birth to 12 months,
with interviews at discharge and at 3, 6 and 12 months, in each of the three rounds. Mothers were
recruited consecutively in the hospitals serving the 18 LHAs, until the intended sample size was
attained. After obtaining informed consent, the first interview with the mother was conducted face-
to-face just before discharge using a 36-item questionnaire that included three questions on feeding
both within the previous 24 hours and from birth (Has the baby had breastmilk? Has the baby had
formula? Has the baby had other fluids, and if so what?), questions on potential confounders, as
well as basic information used to identify the subject. If, for any reason, it was impossible to
interview the mother during hospital stay, the interview was carried out by telephone within one
week of giving birth; this occurred with 212 (12%) mothers. These interviews were performed by
the staff in charge of the BFCI in each LHA. The interviews at 3, 6 and 12 months included five
yes/no questions on foods and fluids taken in the previous 24 hours (breastmilk, formula, animal
milks, non-nutritive fluids, and solids or semisolids), plus an additional question for infants fed only
breastmilk on other foods and fluids taken in the previous 7 days, to compensate for the well-known
overestimate of EBF using a 24-hour recall.25,26 These questions, complemented in the interview at
12 months by questions on breastfeeding problems and ways they were solved or not, were
administered by researchers of the Management and Health Laboratory at Scuola Superiore
Sant’Anna, Pisa, specialized in conducting surveys using Computer-Assisted Telephone
Interviewing (CATI) methods. These interviewers were unaware of the assignment to the early or
late intervention groups. The different categories of feeding were automatically derived from the
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different combinations of answers.27,28 All infants were followed up to 12 months of age
irrespective of their feeding status. The interviews at 12 months in the third round of data collection
were concluded in March of 2012.
The sample size for each cohort was established on the assumption that the BFCI could result in a
10% increase in the rate of EBF at 6 months, from the baseline 25% estimate, as a weighted and
adjusted average of the range from 10% to 60% reported for 2007 or 2008 by the 18 LHAs at
around 5 months of age. These reports were based on data gathered most often at immunization or,
less often, during small cross-sectional or longitudinal surveys, with questionnaires, definitions of
feeding categories and recall periods that were not standardized, and on samples that might have not
represented the population. Based on the above assumption, the sample size for a controlled trial
with a precision of 5% and a power of 80% would amount to 348 subjects per study arm. Due to the
cluster design of the study, this number was doubled to 1392 subjects, 696 per study arm,
considering a possible and conservative design effect of 2. The final sample size of 1740 mother-
infant pairs per round of data collection takes into account a possible 20% loss to follow up. This
sample size was then distributed among the 18 LHAs in proportion to their estimated number of
annual births. Exclusion criteria were a birth weight lower than 2000 g, any post-partum condition
that required admission into a neonatal intensive care unit, the practical impossibility of conducting
the interview (mother or relative unable to understand Italian, English, French or Spanish), and
residence outside the area covered by the LHA. Twins were recruited as separate subjects. As
described in the first companion paper,22 data collection included a self-assessment questionnaire
completed by the 18 LHAs on the progress made in implementing the 7 Steps, each step having a
set of 3 to 11 criteria based on the same model used for the self-assessment of the BFHI.29 In
addition, each LHA was supposed to develop annual action plans and to report on the degree of
implementation.
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After a phase of planning and pilot testing of the tools,22 baseline data collection started in
September 2009 and was successfully completed; the second and third rounds were completed as
planned. Data from face-to-face interviews were manually inputted into customized EpiData Files,
and later exported to MS Excel, by the research assistants in each of the 18 sites. Those from the
CATI system (at 3, 6 and 12 months) were recorded answer-by-answer in real time and
automatically saved into a separate relational database, one for each round of data collection, and
were then extracted to MS Excel files. Finally, all the data from each round were integrated into a
single MS Excel file in Trieste, using the individual ID codes for record linkage. Data were then
checked for completeness, consistency and accuracy, and research assistants at the 18 sites were
notified of possible mistakes for correction after comparison with the original paper records. Data
analysis was carried out using Stata 13. Differences in baseline characteristics were analysed with
Chi squared test or t-test as appropriate. Differences in rates of breastfeeding between early and late
intervention groups at different time points were assessed with logistic regression models using a
backward stepwise selection approach that retained only the variables associated with breastfeeding
at the 0.05 level of significance and took into account the effect of the cluster design (cluster
command in Stata 13). The tested variables were: maternal age, nationality, education, paid
occupation, living with a partner, smoking before and during pregnancy, maternal pre-pregnancy
BMI, gestational diabetes, parity, twin pregnancy, attending an antenatal course, birth in a BFH,
type of delivery, analgesia or anaesthesia in labour, intention to breastfeed, gestational age, birth
weight, timing of the first breastfeed, rooming-in, baby-led feeding, use of bottle and/or pacifier
during hospital stay. The results of the logistic regression models were used to obtain adjusted
breastfeeding rates at different ages, with 95% confidence intervals adjusted for the effect of the
cluster design.
Results
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Table A1 in appendix shows the number of subjects enrolled and followed up to 12 months by LHA
in the early and late intervention groups and by round of data collection. The final database includes
5094 records of enrolled mother-baby dyads, including 107 twins (2%), 126 dyads less than the
intended overall sample size due to the failure of two LHAs, both in the late intervention group, to
participate in one of the data collection rounds. For the analysis at three months, 4704 dyads are
available, a loss of 7.7%; at six months, data are available on 4572 dyads, a further 2.8% loss; at 12
months, 4405 dyads completed the series of interviews, for a total loss to follow up of 13.5% (range
of 9% to 20% among LHAs, no significant differences by intervention group and by round of data
collection), less than the 20% predicted when the sample size was calculated. A total of 281 eligible
mothers declined to be enrolled for various reasons; there were no significant differences between
participant and non-participant mothers except for nationality, the proportion of foreign women
being higher among the latter. Table 2 shows the characteristics of the mothers and infants included
in the analysis, by study group. The demographic characteristics of the sample were similar to
national averages in terms of age and education, while the percentage of women with a paid
employment was slightly higher.30 More women in the sample attended antenatal classes than do on
average throughout the country (44% vs. 35%).31 It is also worth noting that the rate of caesarean
delivery (27-29%) was well below the national average of 38%, although slightly fewer women had
term births (90-92% vs. 93%). There were several statistically significant differences between early
and late intervention groups; these differences were accounted for in the multivariate analysis. The
significantly better perinatal care practices reported by mothers in the early intervention group are
probably due to the higher percentage of births in BFHs.
Table 2. Characteristics of the mothers and infants included in the analysis, by study group.
Early intervention Late intervention p-value
Mean (sd) age (years) 32 (5) 32 (5) 0.121
Mean (sd) education (years) 14 (4) 13 (4) <0.001
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Employment: paid occupation 76% 78% 0.095
Italian 85% 85% 0.535
Living with the partner 97% 96% 0.004
Smoking before pregnancy 29% 27% 0.109
during pregnancy 11% 8% 0.003
Referred BMI <25 80% 79% 0.436
25-29.9 14% 15%
>=30 6% 6%
Gestational diabetes 7% 8% 0.021
Primiparae 57% 54% 0.053
Attendance to antenatal classes 44% 44% 0.716
At least one session on BF 82% 87% 0.002
Delivery at term (38-41 weeks) 92% 90% 0.003
Caesarean section rate 27% 29% 0.058
Anaesthesia or analgesia during
labour/delivery (including C-section)
55% 60% <0.001
Mean (sd) birth weight (g) 3304 (443) 3283 (443) 0.092
Previous breastfeeding experience 41% 44% 0.126
Of which <6 months 31% 37% 0.034
6-12 months 45% 42%
13-24 months 20% 18%
>24 months 4% 3%
Intention to breastfeed current baby 99% 98% 0.126
exclusively for at least 6 m 82% 80% 0.184
Birth in a Baby Friendly Hospital 32% 27% <0.001
Baby latched on within 1 hour 61% 67% <0.001
Rooming-in (24h/day, all infants) 77% 80% 0.080
Baby-led BF (breastfed infants) 90% 89% 0.246
Baby used bottle (all infants) 20% 18% 0.001
Baby used pacifier (all infants) 19% 26% <0.001
Figures 2-6 show the crude rates of EBF at discharge (recall from birth) and at three and six months
(recall 7 days), and the crude rates of any breastfeeding at six and 12 months (recall 24 hours). By
the end of the project, almost 70% of infants were exclusively breastfed at discharge, with an
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increasing trend between rounds 1 and 3 of data collection, and with great variation among sites
(range: 26% to 93%). Both the upward trend between the first and the third round of data collection,
and the variation among sites, are present at 3, 6 and 12 months, for both exclusive and any
breastfeeding. At the third round of data collection, the rates of EBF were fairly high at three
months (54% at round 3, range 36% to 66%), but dropped to 8% (range 1% to 23%) at six months.
These rates were lower than expected, even when considering the figures for the 24-hour recall:
10% (range 3% to 23%). At the end of the project, almost 38% of infants were continuing to
breastfeed at 12 months.
Crude rates, however, cannot be used for comparisons, as this was not a randomised trial and
confounding has to be considered. Table 3 shows the adjusted rates of exclusive and any
breastfeeding at different ages and with different recall periods by intervention group and round of
data collection. Though there was a clear pattern of higher rates in the early intervention group,
there were no statistically significant differences between groups and rounds of data collection as
far as adjusted rates at discharge (not shown) are concerned. The lack of a statistically significant
difference between groups had already been noted at baseline,24 when it was in fact expected
because sites were paired by breastfeeding rates, and persisted through the second and third round
of data collection. Table 3 shows an upward trend of the adjusted rates of breastfeeding between
rounds of data collection, with the exception of EBF and ABF at six months in the early
intervention group. Yet none of the differences between and within groups is statistically
significant. The removal of twins from the dataset did not change the results.
Table 3. Adjusted rates (%) of exclusive (EBF) and any (ABF) breastfeeding at different ages and
with different recall periods by intervention group and round of data collection.
Breastfeeding Early intervention group Late intervention group
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indicators Round n % (95% CI) n % (95% CI)
EBF at 3 m
(recall 24 h)
1 852 58.1 (52.1 – 64.1) 746 52.8 (47.3 – 58.4)
2 845 57.5 (54.4 – 60.7) 645 53.6 (45.7 – 61.6)
3 867 62.3 (59.8 – 64.7) 633 57.9 (53.8 – 62.1)
EBF at 3 m
(recall 7 d)
1 852 49.6 (43.5 – 55.7) 746 43.4 (38.3 – 48.5)
2 845 52.9 (48.7 – 57.2) 645 50.0 (41.5 – 58.4)
3 867 55.9 (52.3 – 59.4) 633 51.1 (47.5 – 54.6)
EBF at 6 m
(recall 24 h)
1 822 9.0 (6.2 – 11.9) 726 7.1 (3.9 – 10.2)
2 835 7.7 (5.4 – 9.9) 636 8.4 (4.7 – 12.2)
3 842 7.6 (4.9 – 10.3) 599 9.6 (7.2 – 12.1)
EBF at 6 m
(recall 7 d)
1 822 5.5 (3.8 – 7.2) 726 5.3 (2.8 – 7.7)
2 835 5.6 (3.7 – 7.4) 636 6.7 (3.7 – 9.8)
3 842 5.4 (2.7 – 8.0) 599 7.6 (5.6 – 9.6)
ABF at 6 m
(recall 24 h)
1 822 67.6 (62.5 – 72.7) 726 62.4 (55.8 – 69.0)
2 835 66.7 (63.5 – 69.9) 636 63.4 (59.4 – 67.3)
3 842 69.0 (66.2 – 71.8) 599 65.4 (61.4 – 69.5)
ABF at 12 m
(recall 24 h)
1 777 32.4 (26.6 – 38.2) 683 28.6 (24.1 – 33.2)
2 820 34.9 (32.4 – 37.5) 611 30.8 (24.0 – 37.6)
3 817 36.2 (32.4 – 40.1) 592 34.9 (30.9 – 39.0)
As the periodic self-assessments had revealed that some of the study sites were making progress in
the implementation of the 7 Steps, while others were lagging behind, we carried out a comparison
by compliance with the intervention, in addition to the analysis by intention to treat. Table 4 shows
the same adjusted rates of breastfeeding of Table 3 after re-grouping the 18 LHAs by compliance
with the intervention. This comparison shows some statistically significant differences between
groups (EBF at three months in rounds 1 and 3, and ABF at six months in rounds 2 and 3) and
between rounds (EBF at three months between rounds 1 and 3 in the non-compliance group), but it
does not show an effect of the intervention. We repeated the same statistical analysis using staff
training to re-group the 18 LHAs into groups with higher and lower training coverage; results (not
shown but available on request) and interpretation did not change. It is interesting to note, however,
that, despite the apparent lack of effect of the intervention and despite similar adjusted rates of
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initiation (between 65% and 72% in both groups), the LHAs in the compliance and higher training
coverage groups presented consistently higher rates of breastfeeding throughout the first year of
life. Once again, the removal of twins did not change the results.
Table 4. Adjusted rates (%) of exclusive (EBF) and any (ABF) breastfeeding at different ages and
with different recall periods by compliance with the intervention and round of data collection.
Breastfeeding
indicators
Compliance group Non-compliance group
Round n % (95% CI) n % (95% CI)
EBF at 3 m
(recall 24 h)
1 978 60.6 (56.2 – 65.0)§ 620 47.6 (43.6 – 51.6)§*
2 979 58.4 (54.9 – 61.9) 511 51.0 (42.8 – 59.1)
3 993 63.5 (61.4 – 65.7)§ 507 54.5 (51.7 – 57.3)§*
EBF at 3 m
(recall 7 d)
1 978 51.1 (46.1 – 56.1)§ 620 39.7 (35.6 – 43.8)§*
2 979 53.9 (49.6 – 58.3) 511 47.3 (38.7 – 55.9)
3 993 56.8 (53.7 – 59.9)§ 507 48.1 (45.1 – 51.2)§*
EBF at 6 m
(recall 24 h)
1 947 9.8 (7.0 – 12.6) 601 5.6 (2.5 – 8.7)
2 956 8.3 (5.5 – 11.1) 515 7.5 (4.1 – 10.9)
3 951 9.4 (6.8 – 12.1) 490 6.5 (3.5 – 9.5)
EBF at 6 m
(recall 7 d)
1 947 6.3 (4.6 – 7.9) 601 4.2 (1.7 – 6.8)
2 956 6.4 (4.0 – 8.8) 515 5.6 (3.1 – 8.1)
3 951 7.0 (4.1 – 9.9) 490 4.7 (2.6 – 6.8)
ABF at 6 m
(recall 24 h)
1 947 68.9 (64.4 – 73.3) 601 59.1 (53.2 – 65.0)
2 956 67.4 (65.2 – 69.6)§ 515 61.1 (57.3 – 65.0)§
3 951 70.3 (67.6 – 73.1)§ 490 62.1 (59.6 – 64.6)§
ABF at 12 m
(recall 24 h)
1 890 33.5 (28.5 – 38.5) 570 26.2 (21.7 – 30.7)
2 931 35.3 (32.2 – 38.4) 500 29.3 (22.3 – 36.3)
3 930 37.6 (34.3 – 40.9) 479 32.1 (28.0 – 36.1)
§ p<0.05 between groups; * p<0.05 between rounds.
We carried out also a logistic regression analysis including all the variables used to adjust the rates
of breastfeeding, plus the rates of EBF at discharge (recall from birth). Tables A2 and A3 in
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appendix show the adjusted rates of breastfeeding and the odd ratios, with their respective 95%
confidence intervals, by early and late intervention and by compliance and non-compliance,
respectively, and by round of data collection, using the rates of the late intervention and non-
compliance groups at round 1 as comparators. Using this logistic regression model, a small number
of odd ratios result in statistically significant differences. These differences, however, do not
indicate a clear association between the BFCI intervention, or compliance with it, and increased
rates of breastfeeding.
Finally, we analysed the answers mothers gave at the 12-month interview when asked if they had
had problems with breastfeeding, where they had looked for help, and whether they thought that
those providing help had solved their problems or not. Overall, the 5094 mothers reported 1082
problems, mainly breast and nipple complaints (39%), not enough milk (32%) and difficulties
latching the baby on (20%), with no statistically significant differences between groups and rounds
of data collection. There were no differences also in the percentage of mothers who sought help for
these problems either. Some relevant statistically significant differences (p<0.05) were found when
mothers were asked to evaluate on a Likert scale the help received by level of usefulness in solving
their problems. Mothers in the early intervention group classified this help as useful or very useful
in 72%, 78% and 82% of cases in rounds 1, 2 and 3, respectively, compared to 63%, 72% and 73%
of mothers in the late intervention group.
Discussion
The protection, promotion and support of breastfeeding in a community is a complex, challenging
and multisectoral set of interventions that need synergistic engagement by a number of different
actors.32 Our non-randomised controlled study measured the effect of the BFCI on the breastfeeding
rates of a community, not only among infants served by health services. It failed to demonstrate a
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statistically significant effect, in particular on the rates of EBF at six months, the primary outcome
under scrutiny. Failure to demonstrate an effect does not necessarily mean that there was no effect.
As shown by our figures and tables, the rates of breastfeeding went up during the project, which
lasted approximately four years. These increases, however, occurred in the LHAs of both groups,
whether they were early or late implementers of the 7 Steps, whether they complied with them to a
greater or lesser extent, and whether they achieved a higher or lower training coverage. None of the
differences was statistically significant. There are many possible explanations for this.
First, the study may not have had the power to identify small differences as significant. The sample
size, in fact, was established on the assumption that the baseline rate of EBF at six months would be
around 25% and that we would be able to detect an increase of 10%. To our surprise, the baseline
rate of EBF at six months was around 10%,24 and it went up by only 1-2% in four years. The
initially presumed 25% rate was probably the result of inaccurate local statistics. Also, there was a
large drop in EBF between three and six months, most likely due to recommendations by the
majority of paediatrician to introduce solids between four and six months, given the lack of
significant differences by maternal occupation and return to work. Second, the lag time between the
implementation of the 7 Steps and their effects on the rates of breastfeeding may be longer than the
duration of the project. So far, six LHAs, all in the early intervention group, were accredited as
Baby Friendly after passing three phases of external evaluation: two in 2012, close to the end of the
research project, three in 2014 and one in 2015, two and three years after the end of the research
project; other LHAs are still working toward accreditation. Third, the 18 LHAs that volunteered to
participate in the study were already highly committed to the promotion of breastfeeding, compared
to other LHAs nationwide, as shown by the presence of accredited BFHs in one third of the study
areas. The implementation of the 7 Steps might have occurred at a time when breastfeeding was
already on the rise. Lastly, the baseline rates of breastfeeding at 3, 6 and 12 months of our 18 LHAs
were higher than those commonly reported in Italy,8,33 partly due to the above mentioned
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commitment to the promotion of breastfeeding, partly because they are located in northern and
central Italy, where rates of breastfeeding are usually higher than in southern regions.34 It may be
harder to increase breastfeeding rates starting from a higher than from a lower level.
A comparison with the trends in the rates of breastfeeding in the same regions where the 18
participating LHAs are located, and during approximately the same period, may help understand if
the small increases reported were associated with BFCI activities or not. This is possible only for
three regions: Lombardia (5 out of its 15 LHAs were included in the BFCI project), Emilia
Romagna (3 of 11), and Friuli Venezia Giulia (2 of 6). In Lombardia, the rate of EBF at the first
immunization (2-3 months of age) was 38% in 2006 and 47% in 2012; at the second (around five
months of age), it went up from 19% to 27% in the same period.35 In Emilia Romagna, the rates of
EBF at the first and second immunization went up from 47% to 48% and down from 41% to 30%,
respectively, between 2008 and 2011.36 In Friuli Venezia Giulia, the rate of EBF at the second
immunization was 38% in 2004,37 and it went down to 34% in 2011.
38 Our data, however, are very
accurate; the age of the infant, for example, is the exact age plus or minus a week. Instead, the data
from the three regions above refer to infants whose ages may be within a range of one or two
months. They may also be less standardized, and perhaps biased, because they are gathered by
professionals in their own LHA, while our data were collected by independent interviewers. The
samples used in routine surveillance systems may also be less representative than in our sample.
More recently, the National Institute of Statistics published a preliminary report of a survey on
pregnancy, childbirth and breastfeeding carried out in 2013 on a nationally representative sample.39
The results, which are not yet broken down by region, show that between 2005 and 2013 the
initiation of breastfeeding went up from 81.4% to 85.5%, while the median duration increased from
7.3 to 8.3 months, with small differences between macroregions. The survey indicates that there is a
general upward trend, but unfortunately it does not allow to gauge the effect of the BFCI, because it
does not report trends in the rates of EBF.
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Our study has some limitations. As it was impossible to randomise the 18 LHAs, the results may be
biased by some residual confounding, despite our efforts to adjust data for well-known confounders
before any comparison between groups. As already mentioned, our study might not have the power
to identify small statistically significant improvements in breastfeeding rates. In addition, it may
have been too short: the effects of the BFCI may become evident over a longer period. Finally, our
study was carried out in a real-life situation. This means that the actual implementation of the
intervention did not necessarily follow the timing and mode proposed by the research protocol, and
was instead adapted to each reality and tailored to the local situation.21 For example, the
development and approval of a written policy (Step 1) may take different amounts of time in
different LHAs, because of factors such as the continuity and commitment of decision makers, as
well as the complexity of the organization. Some of the 18 LHAs are small and compact, whereas
others are large and located in cities like Rome, Milan and Bologna, where the number of actors is
much higher. This has a bearing on the implementation of Step 2; it is easier to conduct courses
where the number of health professionals is small and stable, while it is much more difficult to
achieve a high coverage with large numbers of professionals and a high turnover. Similar
considerations are relevant for the other steps, and particularly for Step 6, the provision of a
welcoming atmosphere for breastfeeding families, and Step 7, the promotion of co-operation
between healthcare staff, breastfeeding support groups and the local community, which are closely
related. With such a heterogeneous and continuously changing group of study units, it was difficult
to decide what to compare with what, making the interpretation of results very problematic.
To conclude, the BFCI is a complex intervention carried out in socially and geographically different
areas.22 Implementing the 7 Steps requires years of hard work geared toward sustainable changes by
policy and decision makers, all categories of health professionals, public and private health
organizations, mother-to-mother support groups, volunteer organizations and local administrators.
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The challenge is to modify the practices of health care professionals and achieve organizational
changes, an objective that is hard to achieve even in the BFHI,32,40 a much less complex initiative,
but also to shape and activate mutually supportive networks. It was encouraging to see all the
coordinated efforts being made in a coordinated way in the 18 LHAs that volunteered to participate
in this project. But complex interventions are not only difficult to implement, it is difficult to assess
their effects in real life.41 The design and methods used in this study are far from perfect, but it
would be difficult to measure the effect of the BFCI, if any, using the rigorous methods of a
randomized controlled trial. The project is already bringing about changes in the way breastfeeding
is protected, promoted and supported in the 18 LHAs. This study does not allow to determine that
the BFCI is effective nor that it is ineffective, but it has paved the way for better practices in the 18
LHAs and hopefully in other regions of Italy and in other countries.
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Acknowledgements
This work was supported by a financial contribution from the Institute for Maternal and Child
Health IRCCS Burlo Garofolo, Trieste, Italy (research grant n. 32/08), and by funds made available
by the Italian Committee for UNICEF and by each of the participating LHAs for local activities.
The study could not have been carried out without the commitment of dozens of dedicated health
professionals in the 18 study sites, too many to name individually, and the dedication of the
interviewers based at the School of Management and Health in Pisa, Italy. Special thanks to
Leonardo Speri, former coordinator of the BFHI/BFCI Task Force of the Italian Committee for
UNICEF, who strongly supported the idea of setting up this research project.
The study was approved by the Ethics Committees of the Institute for Maternal and Child Health
IRCCS Burlo Garofolo in Trieste and of the 18 participating Local Health Authorities: Bassano del
Grappa, Biella, Bologna, Cesena, Forlì, Friuli Occidentale, Mantova, Marche, Massa Carrara,
Milano, Milano 1, Milano 2, Oristano, Roma B, Sondrio, Trieste, Verbania and Verona.
The following are members of the BFCI Study Group, in addition to the main authors: Alessandra
Knowles, Paola Pani, Claudia Carletti (Institute for Maternal and Child Health IRCCS Burlo
Garofolo, Trieste); Annacatia Miola, Stefania Battocchio, Paola Dal Zotto (Local Health Authority,
Bassano del Grappa); Emiliana Mosca, Angelo Penna, Antonella Tedesco (Local Health Authority,
Biella); Franco Garofalo, Anna Perona (Department of Paediatrics, Biella Hospital); Paola Lenzi,
Marilina Colombo, Cledemaria Garavini (Local Health Authority, Bologna); Massimo Farneti,
Marcella Lombardi (Local Health Authority, Cesena); Anna Maria Baldoni, Laura Borghesi, Paola
Dalla Casa, Enrico Marchiani, Claudia Zoli (Local Health Authority, Forlì); Federica Braida,
Oriana Raminelli, Anna Furlan (Local Health Authority, Pordenone); Fiorella Talassi, Loretta
Grossi, Gabriele Gianella, Paola Mussini (Local Health Authority, Mantova); Rita Gatti, Grazia
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Pompilio (Maternal and Child Health Centre, Loreto); Marco Morbidoni (Department of
Epidemiology, Ancona); Mauro Tiriduzzi, Nadia Liberatore, Susi Campanari, Paola Catena
(Department of Obstetrics and Gynaecology, Osimo Hospital); Laura Polenta, Roberta Freddara
(Salesi Hospital, Ancona); Fabiola Salvetti, Cinzia Luzi, Romana Prosperi Porta (Department of
Pediatrics, Massa Carrara Hospital); Rita Mascheroni, Miriam Lelli, Graziella Cattaneo, Raffaella
Gennaretti, Antonia Tomaselli (Local Health Authority, Milan); Maria Elena Pirola, Domenico
Arensi, Giovanni Beghi, Gigliola Ronchi, Piera Ceresa, Silvano Santucci (Local Health Authority,
Milan 1); Luigi Acerbi, Maura Franzetti, Roberto Lucchini, Giuseppina De Gasperi (Local Health
Authority, Milan 2); Maria Antonietta Grimaldi (Local Health Authority, Oristano); Patrizia
Auriemma, Patrizia Proietti, Elisa Lazzaro (Local Health Authority, Rome B); Eloisa Del Curto,
Patrizia Sossi, Livia Tabacchi, Paola Abbiati (Local Health Authority, Sondrio); Maria Vittoria Sola
(Local Health Authority, Trieste); Andrea Guala, Raffaella Visentin, Luigina Boscardini, Elena
Ferzetti, Laura Cantalupi (Local Health Authority, Verbano-Cusio-Ossola); Emanuela Battisti,
Daniela Dainese, Francesca Lazzari, Elisa Pastorelli (Local Health Authority, Verona).
Contributors: AC designed and coordinated the study, participated in data analysis and
interpretation, and drafted and revised the paper. He acts as guarantor. MEB and EMC pilot tested
and developed the BFCI tools used in the study, were in charge of monitoring the implementation
of BFCI activities by gathering and analysing periodic reports from the study sites, and contributed
to the interpretation of results. AM and LCES centralized and checked all the data gathered in the
three rounds of data collection in a continuous feedback with the study sites, were in charge of
making the datasets ready for analysis, and contributed to the interpretation of results. AMM was
responsible for all the CATI interviews and prepared the relative datasets. MM carried out the
statistical analysis. All the members of the BFCI Study group participated in the implementation of
BFCI activities and in the collection of data for the first interview. All co-authors, including the
members of the BFCI Study Group, approved the final version of the manuscript.
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The manuscript’s guarantor affirms that this manuscript is an honest, accurate, and transparent
account of the study being reported; that no important aspects of the study have been omitted; and
that any discrepancies from the study as planned (and, if relevant, registered) have been explained.
Data sharing: the full dataset is available on reasonable request from the corresponding author at
[email protected]. Consent for data sharing was not obtained, but the presented data
are anonymised and risk of identification is low.
Competing interests: none declared.
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Figures’ titles
Figure 1. A sketch of the study design.
Figure 2. Rates of exclusive breastfeeding at discharge (recall from birth) by site, group and round
of data collection.
Figure 3. Rates of exclusive breastfeeding at three months (recall 7 days) by site, group and round
of data collection.
Figure 4. Rates of exclusive breastfeeding at six months (recall 7 days) by site, group and round of
data collection.
Figure 5. Rates of any breastfeeding at six months (recall 24 hours) by site, group and round of data
collection.
Figure 6. Rates of any breastfeeding at 12 months (recall 24 hours) by site, group and round of data
collection.
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Figure 1. A sketch of the study design. 76x59mm (300 x 300 DPI)
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Figure 2. Rates of exclusive breastfeeding at discharge (recall from birth) by site, group and round of data collection.
54x36mm (300 x 300 DPI)
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Figure 3. Rates of exclusive breastfeeding at three months (recall 7 days) by site, group and round of data collection.
54x32mm (300 x 300 DPI)
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Figure 4. Rates of exclusive breastfeeding at six months (recall 7 days) by site, group and round of data collection.
54x36mm (300 x 300 DPI)
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Figure 5. Rates of any breastfeeding at six months (recall 24 hours) by site, group and round of data collection.
54x36mm (300 x 300 DPI)
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Figure 6. Rates of any breastfeeding at 12 months (recall 24 hours) by site, group and round of data collection.
54x36mm (300 x 300 DPI)
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Appendix
Table A1. Subjects enrolled and followed up to 12 months by LHA in the early and late intervention groups and by round of data collection
Group LHA Assigned
sample
size
Round 1
(01/09/09-31/03/10)
Round 2
(01/09/10-31/03/11)
Round 3
(01/09/11-31/03/12)
Total
Enrolled F-up
12 m
Loss Enrolled F-up
12 m
Loss Enrolled F-up
12 m
Loss Enrolled F-up
12 m
Loss
Early
interv
ention
5 124 124 103 17% 126 115 9% 129 116 10% 379 334 12%
6 48 48 38 21% 47 43 9% 47 42 11% 142 123 13%
8 54 56 52 7% 61 55 10% 58 50 14% 175 157 10%
9 121 122 99 19% 122 93 23% 123 105 15% 367 297 19%
10 109 109 91 17% 112 105 5% 113 99 12% 334 295 12%
14 122 120 96 20% 117 102 13% 122 109 11% 359 307 14%
15 126 126 117 7% 127 111 13% 126 107 15% 379 335 12%
16 134 134 121 10% 135 122 10% 134 119 11% 403 362 10%
18 103 103 81 21% 103 94 9% 103 89 14% 309 264 15%
Total 942 942 798 15% 949 840 11% 955 836 12% 2846 2474 13%
Late in
tervention
1 136 139 117 16% 142 125 12% 140 122 13% 421 364 14%
2 85 94 77 18% 101 92 9% 100 88 12% 295 257 13%
3 50 51 37 27% 49 42 14% 47 40 15% 147 119 19%
4 143 147 131 11% 142 133 6% - - - 289 264 9%
7 115 129 101 22% - - - 130 118 9% 259 219 15%
11 62 61 54 11% 61 49 20% 62 53 15% 184 156 15%
12 68 68 56 18% 67 52 22% 69 55 20% 204 163 20%
13 43 53 50 6% 53 43 19% 51 43 16% 157 136 13%
17 97 97 89 8% 98 80 18% 97 84 13% 292 253 13%
Total 799 839 712 15% 713 616 14% 696 603 13% 2248 1931 14%
Grand total 1741 1781 1510 15% 1662 1456 12% 1651 1439 13% 5094 4405 14%
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Table A2. Adjusted rates of breastfeeding (AR) and odd ratios (OR), with their respective 95% confidence intervals (95% CI), by early and late
intervention groups and round of data collection. Late intervention group at round 1 of data collection as comparator. Statistically significand
differences (p<0.05) in bold.
Breastfeeding
indicators
Round of
data
collection
Early intervention group Late intervention group
AR
(%)
95% CI
(%)
OR 95% CI AR
(%)
95% CI
(%)
OR 95% CI
EBF at
discharge
(recall 24 h)
1 87.2 83.4-91.1 1.03 0.62-1.70 86.9 82.7-91.1 1 -
2 88.4 84.8-92.1 1.15 0.69-1.91 85.6 80.9-90.2 0.89 0.61-1.31
3 87.4 83.5-91.3 1.04 0.63-1.74 86.4 82.0-90.8 0.96 0.65-1.40
EBF at
discharge
(from birth)
1 72.2 62.0-82.5 1.36 0.66-2.76 65.7 54.0-77.5 1 -
2 73.6 63.6-83.6 1.45 0.71-2.96 70.2 59.1-81.2 1.23 0.90-1.67
3 73.1 63.0-83.2 1.41 0.69-2.89 73.5 63.3-83.8 1.45 1.05-1.99
EBF at 3
months
(recall 24 h)
1 57.7 52.6-62.8 1.13 0.86-1.49 54.7 49.2-60.2 1 -
2 57.1 51.9-62.3 1.10 0.83-1.45 54.5 48.8-60.2 0.99 0.79-1.25
3 61.8 56.8-66.9 1.34 1.01-1.77 58.1 52.4-63.7 1.15 0.90-1.46
EBF at 3
months
(recall 7 d)
1 48.6 42.9-54.3 1.13 0.82-1.55 45.6 39.7-51.6 1 -
2 52.0 46.3-57.7 1.29 0.94-1.78 51.4 45.2-57.6 1.26 1.00-1.58
3 54.9 49.2-60.6 1.45 1.05-2.00 51.4 45.1-57.6 1.26 0.99-1.59
EBF at 6
months
(recall 24 h)
1 8.6 5.6-11.7 1.17 0.67-2.05 7.4 4.6-10.3 1 -
2 7.3 4.6-9.9 0.98 0.55-1.71 8.3 5.1-11.5 1.13 0.77-1.65
3 7.3 4.6-9.9 0.97 0.55-1.71 9.3 5.8-12.8 1.27 0.86-1.87
EBF at 6
months
(recall 7 d)
1 5.2 3.0-7.3 0.93 0.50-1.73 5.5 3.2-7.9 1 -
2 5.2 3.1-7.3 0.93 0.50-1.72 6.7 3.9-9.5 1.22 0.80-1.84
3 5.0 2.9-7.1 0.90 0.49-1.66 7.1 4.1-10.0 1.30 0.85-1.98
ABF at 6
months
(recall 24 h)
1 67.8 63.1-72.6 1.18 0.94-1.48 64.1 58.9-69.3 1 -
2 66.9 62.1-71.7 1.13 0.90-1.42 63.7 58.3-69.1 0.98 0.77-1.24
3 69.1 64.4-73.8 1.25 0.99-1.57 66.5 61.2-71.9 1.11 0.87-1.42
ABF at 12
months
(recall 24 h)
1 32.0 27.2-36.8 1.12 0.86-1.45 29.7 24.8-34.5 1 -
2 34.8 29.9-39.6 1.26 0.98-1.63 31.1 26.0-36.2 1.07 0.84-1.37
3 35.9 31.0-40.9 1.33 1.03-1.72 34.8 29.4-40.1 1.26 0.98-1.62
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Table A3. Adjusted rates of breastfeeding (AR) and odd ratios (OR), with their respective 95% confidence intervals (95% CI), by compliance with the
intervention and round of data collection. Non-compliance group at round 1 of data collection as comparator. Statistically significand differences
(p<0.05) in bold.
Breastfeeding
indicators
Round of
data
collection
Compliance group Non-compliance group
AR
(%)
95% CI
(%)
OR 95% CI AR
(%)
95% CI
(%)
OR 95% CI
EBF at
discharge
(recall 24 h)
1 87.2 83.5-90.8 1.02 0.60-1.75 86.9 82.1-91.8 1 -
2 86.9 83.2-90.6 0.99 0.58-1.70 88.0 83.3-92.7 1.10 0.71-1.71
3 87.9 84.4-91.4 1.09 0.64-1.88 84.9 79.5-90.3 0.85 0.55-1.30
EBF at
discharge
(from birth)
1 70.3 60.4-80.2 1.16 0.53-2.50 67.2 53.9-80.5 1 -
2 69.6 59.6-79.6 1.12 0.52-2.41 76.2 64.9-87.4 1.56 1.09-2.23
3 72.2 62.7-81.7 1.27 0.59-2.75 74.5 62.9-86.0 1.42 1.00-2.04
EBF at 3
months
(recall 24 h)
1 60.5 56.9-64.2 1.64 1.26-2.13 48.3 43.3-53.4 1 -
2 58.3 54.6-62.0 1.49 1.15-1.93 51.4 46.1-56.7 1.13 0.88-1.46
3 63.4 59.9-67.0 1.85 1.43-2.41 54.6 49.4-59.8 1.28 0.99-1.67
EBF at 3
months
(recall 7 d)
1 50.4 45.7-55.1 1.42 1.03-1.95 41.8 35.8-47.8 1 -
2 53.4 48.7-58.0 1.60 1.16-2.19 48.8 42.4-55.2 1.33 1.03-1.72
3 56.2 51.6-60.9 1.79 1.30-2.46 48.5 42.1-54.8 1.31 1.01-1.71
EBF at 6
months
(recall 24 h)
1 9.6 6.6-12.5 1.67 0.93-3.01 5.9 3.3-8.6 1 -
2 8.1 5.5-10.6 1.38 0.77-2.49 7.7 4.3-11.0 1.31 0.83-2.08
3 9.2 6.3-12.0 1.60 0.89-2.88 6.4 3.5-9.3 1.08 0.66-1.76
EBF at 6
months
(recall 7 d)
1 6.1 3.8-8.3 1.39 0.72-2.67 4.4 2.2-6.7 1 -
2 6.1 3.8-8.3 1.39 0.73-2.67 5.8 2.9-8.7 1.32 0.80-2.19
3 6.7 4.3-9.2 1.55 0.81-2.98 4.5 2.1-6.8 1.01 0.59-1.73
ABF at 6
months
(recall 24 h)
1 68.7 64.5-72.9 1.40 1.07-1.84 61.0 55.4-66.6 1 -
2 67.3 63.0-71.5 1.31 1.01-1.71 61.7 55.9-67.5 1.03 0.79-1.34
3 70.1 66.0-74.3 1.50 1.15-1.97 64.0 58.4-69.6 1.14 0.87-1.48
ABF at 12
months
(recall 24 h)
1 33.0 28.6-37.4 1.31 0.97-1.76 27.3 22.2-32.5 1 -
2 35.0 30.5-39.4 1.43 1.07-1.92 29.8 24.3-35.4 1.13 0.86-1.50
3 37.2 32.6-41.7 1.57 1.17-2.11 32.5 26.9-38.2 1.28 0.96-1.71
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