Translational Research: Bridging the Gap between Long-Term Weight Loss Maintenance Research and Practice

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ranslational Research: Bridging the Gapetween Long-Term Weight Loss Maintenanceesearch and Practice

EREMY D. AKERS, PhD, RD; PAUL A. ESTABROOKS, PhD; BRENDA M. DAVY, PhD, RD

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BSTRACThe number of US adults classified as overweight or obeseas dramatically increased in the past 25 years, resulting insignificant body of research addressing weight loss andeight loss maintenance. However, little is known about

he potential of weight loss maintenance interventions to beranslated into actual practice settings. Thus, the purpose ofhis article is to determine the translation potential of pub-ished weight loss maintenance intervention studies by de-ermining the extent to which they report informationcross the reach, efficacy/effectiveness, adoption, implemen-ation, and maintenance (RE-AIM) framework. A secondaryurpose is to provide recommendations for research basedn these findings. To identify relevant research articles, aiterature search was conducted using four databases; 19eight loss maintenance intervention studies were identi-ed for inclusion. Each article was evaluated using theE-AIM Coding Sheet for Publications to determine thextent to which dimensions related to internal and externalalidity were reported. Approximately half of the articlesrovided information addressing three RE-AIM dimen-ions, yet only a quarter provided information addressingdoption and maintenance. Significant gaps were identifiedn understanding external validity, and metrics that couldacilitate the translation of these interventions from re-earch to practice are presented. Based upon this review, its unknown how effective weight loss maintenance inter-entions could be in real-world situations, such as clinical orommunity practice settings. Future studies should belanned to address how weight loss maintenance inter-ention programs will be adopted and maintained, withpecial attention to costs for participants and for programmplementation.

Am Diet Assoc. 2010;110:1511-1522.

. D. Akers is an assistant professor, James Madison Uni-ersity, Harrisonburg, VA; at the time of the study, he wasdoctoral student, Virginia Polytechnic Institute andtate University, Blacksburg. P. A. Estabrooks is a profes-or and B. M. Davy is an associate professor, Virginiaolytechnic Institute and State University, Blacksburg.Address correspondence to: Brenda M. Davy, PhD,D, Virginia Tech, 221 Wallace Hall (0430), Blacks-urg, VA 24061. E-mail: [email protected] accepted: May 13, 2010.Copyright © 2010 by the American Dietetic

ssociation.0002-8223/$36.00

edoi: 10.1016/j.jada.2010.07.005

2010 by the American Dietetic Association

he number of US adults classified as overweight(body mass index �25) or obese (body mass index�30) has dramatically increased in the past 25 years

1-3). Due to the adverse health outcomes associated withbesity (1,4-6), the body of literature targeting weightoss strategies has abounded, yet rates of concomitanteight regain are well documented (7-10). As a result, theeed for practical, affordable, and clinically useful inter-ention strategies that maintain weight loss is para-ount (11).Numerous interventions have included behavioral

trategies in clinical trials investigating weight lossaintenance, described as an intervention aimed to pre-

ent weight regain following weight loss (11-30). Behav-oral strategies associated with successful weight loss

aintenance include high levels of physical activity12,16,20,22), self-monitoring of food consumption andody weight (11,29-31), social and interactive support13,14,17,21,29,30), dietary interventions (18,19,27,28),sychological intervention (23-26), and limiting themount of time spent watching television (10). Interven-ions that include weight loss medications combined withietary modification, supplementation with caffeine orrotein, prolonged participant contact, problem-solvingherapy, and acupressure may also promote weight lossaintenance (32). However, the potential for these strat-

gies to be translated into regular community or clinicalnvironments is unknown. The following vignette is usedo illustrate this point.

Paula Ellis, MS, RD, is the director of wellness for a largemanufacturer. She has been asked to develop a worksiteweight maintenance program to follow their successful8-week weight loss program. She found two recent re-search articles describing 12-month weight loss mainte-nance interventions and must decide which approach isbest suited to implement for her company’s employees.Program A was tested at a university medical clinic byresearch assistants; it involved weekly individual counsel-ing sessions and weight checks. This program was effec-tive in maintaining body weight (�2.3 kg) in 85% of itsparticipants. Program B was tested in an urban YMCA byYMCA staff. The program used a printed program train-ing manual and monthly group sessions. About 40% ofProgram B participants maintained their weight (�2.3kg). Paula decided on Program B because it had a manual,appeared to be fairly successful, and seemed to be morefeasible to deliver. However, she felt a bit uncertain withher decision, as Program A had a better success rate.

The purpose of this vignette is not to demonstrate thatprogram manual makes dissemination of a program

asier or that practitioners should choose the simpler

Journal of the AMERICAN DIETETIC ASSOCIATION 1511

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ption, even if it is less effective. The purpose is to dem-nstrate that examining evidence-based interventionsrom a practice perspective includes the consideration ofany factors that are not often reported within the re-

earch context. Although there is a growing body of liter-ture addressing methods to maintain weight loss11,20,23,30,33,34), there is relatively little reporting onhe potential for these methods to be translated intoegular practice settings. Thus, it is not surprising that,ithin the health care setting, the process of translating

esearch into evidence-based practice may take 15 to 20ears to occur (35,36).This lag may be attributed to a lack of reporting on

actors important to the audience that would ultimatelydopt and implement the intervention (37), and to theinear research production model that emphasizes inter-al over external validity. Specifically, Flay and Phil (38)rovide an example of the translation process. First, anntervention must undergo an efficacy trial, defined astests of whether a . . . program does more good thanarm when delivered under highly controlled and opti-um conditions” (39). Optimal conditions may include

creening out less compliant patients (39); thus, the gen-ralizability of the interventions tested in an efficacytudy is unknown. The next stage in the translation pro-ess is an effectiveness trial that “provides tests ofhether a . . . program does more good than harm whenelivered under real-world conditions” (38). Effectivenessrials are primarily randomized controlled trials held tohe Consolidation of Standards for Reporting Trials rec-mmendations, which emphasize internal validity whilenly providing modest descriptive recommendations forxternal validity factors (40). This research model hasighlighted the need to focus on translational researchnd its clinical implications. Translational research isften defined as having two phases: the translation ofasic science into clinical research; and how interventionsre adopted, implemented, and sustained in a clinical orommunity setting (41).

Glasgow and colleagues (37,42-46) have proposed aroader set of metrics and indicators that provide addi-ional information that is needed by practitioners whenonsidering the translation of an evidence-based inter-ention into routine practice. Specifically, translation ofesearch into practice is best served when studies reportore balanced information on internal and external va-

idity. To address this need, the reach, efficacy/effective-ess, adoption, implementation, and maintenance (RE-IM) evaluation framework was developed to provide

ontext for practitioners to consider and compare re-earch-based interventions (37,42,46). Importantly, costs considered a key factor across the five dimensions. Theve dimensions can be applied to the evaluation of healthehavior interventions and estimate the potential publicealth influence of interventions and information thatan facilitate translation into practice. Definitions andxamples reflecting each of these dimensions can beound in Figure 1.

The use of the RE-AIM framework may improve theeporting of factors related to external validity and moreccurately inform the potential of research to be trans-ated into practice (47). This framework can also provide

eaningful information for practitioners. For example, if t

512 October 2010 Volume 110 Number 10

aula from our vignette knew that one of the programsas delivered by someone with her level of training and

xpertise, had demonstrated effectiveness in a settingimilar to her workplace, cost $3 per employee to imple-ent, and could be sustained with minimal cost to the

rganization, her choice would have been more informed.nfortunately, there may be a gap in the literature re-

ated to the extent to which weight loss maintenancentervention studies report across these dimensions.hus, the purpose of this article is to determine theranslation potential of published weight loss mainte-ance intervention studies by determining the extent tohich they report information across the RE-AIM frame-ork. A secondary purpose is to provide recommenda-

ions for research based upon these findings.

ETHODSo identify research articles related to weight loss mainte-ance intervention for translation potential, a literatureearch was conducted using four databases (Medline,ubMed, PSYCinfo, and Ebscohost), using standardizedearch terms as follows: weight maintenance, long-termeight loss maintenance, effectiveness weight loss mainte-ance, and efficacy weight loss maintenance. For inclusion,rticles must have been published in English, been a ran-omized controlled trial of a long-term weight loss mainte-ance intervention that included a weight loss trial and �1ear of intervention, used an adult (�17 years old) studyopulation, conducted the research after February 1988,nd included efficacy/effectiveness research. Articles werexcluded if they focused on pharmaceuticals, follow-ups,urgery, and weight gain prevention; subsequent articleseporting on the same intervention study were also ex-luded.

Four hundred ninety-eight relevant articles were ini-ially identified. Most were excluded because they did noteet inclusion criteria (n�382). Others were not included

ue to exclusion criteria (n�96). Nineteen articles metnclusion criteria and are described in Figure 2.

he RE-AIM Coding Sheet for Publicationso evaluate the translation potential of weight loss main-enance studies, we utilized the RE-AIM Coding Sheet forublications (48). The Coding Sheet includes a series ofes or no questions for indicators within each of the fiveE-AIM dimensions. The Coding Sheet is available inigure 3 (available online at www.adajournal.org). Eachtudy was coded by two of the three authors and resultsere compiled into a spreadsheet, reported graphically inigure 4. Cohen’s � was used as a measure of agreementetween the reviewers (49). Discrepancies were discussedy all three authors and consensus was achieved acrosseviewed studies.The coding sheet includes six sections: article charac-

eristics, reach, efficacy/effectiveness, adoption, imple-entation, and maintenance. The original coding sheetas revised for the present analysis, to include refine-ents of RE-AIM information (45).Specific details of the coding process are as follows. For

he “demographic and behavioral information” question,

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es was coded only if the study included sex, age, socialconomic status, and race. For the question “describedarget population,” yes was coded only if the study de-cribed a specific population being targeted for interven-ion (eg, intervention specifically targeted overweight orbese African-American women in urban Richmond, VA)nd not just the individuals who were enrolled (eg, thetudy sample was 50% African American). For the ques-ion on reporting of the theoretical basis of the interven-ion, yes was coded only if an evidence-based theoreticalodel or construct was utilized (eg, transtheoreticalodel or self-efficacy). With respect to “participation

ate” on the coding sheet, two participation levels weredentified (37,50). Level 1 participation rate was calcu-ated based on the sample size divided by the total num-er of individuals projected in the target population.evel 2 participation rate was calculated based on theample size divided by the number of individuals whoere either exposed to, or responded to, recruitment ef-

orts (37). Because there was little reporting of Level 1articipation rate, any study that reported Level 2 ratesas coded as providing information on Reach.

TATISTICAL ANALYSIStandardized effect sizes d�(x -x )/

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Reach (R) The proportion and representativenesindividuals willing to participate ingiven intervention.

Efficacy/effectiveness (E) The influence of an intervention onimportant outcomes, including potenegative effects, quality of life, andeconomic outcomes.

Adoption (A) The proportion and representativeneslocations and intervention staff wilinitiate and adopt an intervention.

Implementation (I) How consistently various elements ofintervention are delivered as intendby intervention staff, and the timecost of the intervention.

Maintenance (M) The extent to which participants makmaintain a behavior change and thsustainability of a program or policthe setting in which it was interve

igure 1. Description of reach, efficacy/effectiveness, adoption, implemxisting weight loss maintenance literature.

1 2 pooled standard deviationere calculated (51) across studies with x1-x2 represent- h

ng mean change in weight (in kilograms) from baselineeight maintenance to post-intervention weight mainte-ance. All RE-AIM coding was evaluated across raterssing Cohen’s � (49) and the findings were summarizednd presented in percents. Percents were computed atwo levels. First, the proportion of indicators reportedithin each RE-AIM dimension was computed (ie, num-er of indicators reported for a given dimension dividedy the total number of possible indicators within theimension). Second, the proportion of studies that re-orted specific indicators within each RE-AIM dimensionas computed (ie, number of studies that reported di-ided by total number of studies). These methods areimilar to that recommended for analysis of the RE-AIMetrics (37,52).

ESULTScoring of the articles resulted in a substantial agree-ent between raters (��.83�.20), with the range.25�.02 to .89�.04 between the RE-AIM dimensions.he mean effect size of the scored articles was�0.38�0.05, with effect sizes ranging from 0.00 to 1.22.etails of the 19 studies reviewed, according to RE-AIMimension, and categorized by intervention type (ie, diet-nly; diet and behavior change; physical activity and be-

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Svetkey and colleagues provided a strong reach componentto their research by giving a description of the proposedtarget population and a detailed description of studyparticipants (ie, age, weight status, sex, race/ethnicity,and education). Information was provided as to howparticipants were identified, and a thorough descriptionof inclusion/exclusion criteria (11).

While many studies have a strong efficacy/effectivenessdimension, Wing and colleagues reported many of thedimension’s components, including a thoroughexplanation of the study design, measures, and results.The article reports imputation and intent to treatprocedures, and discusses unintended consequences ofthe study and attrition (30).

oHarvey-Berino and colleagues described the setting and

location of the intervention as well as a description andexpertise of the individuals delivering the intervention(14).

Wing and colleagues provide an acceptable implementationdimension, including information on the number ofparticipant contacts and the timing and duration ofcontacts. Information was provided on study attendancerates and the percentage of the protocol delivered asintended (29).

Leermakers and colleagues provide information onmaintenance dimension by assessing their studyparticipants 6 months after the completion of the study.Weight gain and the attrition rate were provided (20).

ion, and maintenance (RE-AIM) dimensions with examples found in the

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Study Study design

Dimension

ecnanetniaMnoitatnemelpmInoitpodAssenevitceffe/ycacfifEhcaeR

Diet-only interventions

Lantz andcolleagues,2003 (18)

18-mo RCTa

2 groups (both groups followed ahypocaloric diet minus 500 kcal/d)

Intermittent: consume VLCDc (450 kcal/d)for 2 wks every third month

On-demand: consume VLCD whenweight increases3 kg from baseline

n 334b

18-60 yb

247 womenb

BMId 30b

Intervention group lost 7.0 kg; on-demand grouplost 9.1 kg. No significant differencesbetween groups.

65% attritionb

Participants were monitored by aphysician, registered dietitian,and a nurse at various timepoints in a clinical setting.

Monthly meetings No data

Ryttig andRosner,1995 (28)

12-mo RCT2 groups:Group 1: hypocaloric diet (1,600 kcal/d),

of which 220 kcal were provided bya supplement

Group 2: hypocaloric diet (1,600 kcal/d),no supplement.

n 5239.1 5.5 yb

41 womenBMI 39.1 5.5b

% weight gain in Group 1 was 9.3 9.4%:8.0 8.2 kg

% weight gain in Group 2 was 12.3 10.0%:12.3 9.7 kg

Group 1 regained 39 35.7% of weight lostduring weight loss trial compared to54 38.5% in Group 2.

22% attritionEffect size:Group 1-Group 2: 0.49

Interventions and assessmentswere delivered by a nurse anddietitian in a universityoutpatient obesity clinic.

Both groups were seen forassessments every month for7 mo, then every seventh weekduring the remainder of theintervention.

No data

Diet and behavior change interventions

Layman andcolleagues,2009 (19)

8-mo RCT2 groups:Low carbohydrate to protein ratio (LOW):

40% energy from carbohydrate, 30%from protein, 30% from fat

High carbohydrate to protein (HIGH):55% of energy from carbohydrate,15% from protein, 30% from fat

n 10345.4 1.2 yb

72 womenb

BMI 32.6 0.8

Mean weight change (kilograms) from baseline:Intent to treat:LOW: 9.3 1.0HIGH: 7.4 0.6Completers:LOW 10.4 1.2HIGH 8.4 0.9No difference between groups in mean weight

change31% attritionEffect sizee:LOW-HIGH: 0.31

Group meetings were led by aresearch dietitian at a weightmanagement research facility.

Any unexcused absence wasfollowed up by a telephonecall.

Both groups were required toattend a 1-h meeting eachweek.

The LOW group had a significantlygreater number of participants(64%) complete compared tothe HIGH group (45%).

Compliance with group meetingswas 75%.

No data

Perri andcolleagues,1988 (24)

13-mo RCT:5 groups:Behavior therapy (B): Control, no

maintenance interventionTreatment contact (BC): Therapist

contacts with 80 min/wk of exerciserecommended

BC plus social influence program (BCS):Therapist contacts plus program ofsocial influence strategies

BC plus aerobic exercise maintenanceprogram (BCA): Therapist contactsplus aerobic exercise program

BC plus aerobic plus social influence(BCAS): Therapist contacts plusaerobic exercise program plus socialinfluence

n 9422-59 yb

97 womenb

Weight regain over 13 mo for each intervention:B: 7.2 kgBC: 1.76 kgBCS: 2.91 kgBCA: 3.91 kgBCAS: 0.13 kg2% attrition

Interventions were delivered by aclinical psychologist,physician, or a nursepractitioner.

BC, BCS, BCA, and BCAS received26 biweekly therapist contacts.

Participants attended 66.8% ofthe 26 scheduled sessions.

No data

Ryttig andcolleagues,1997 (27)

26-mo RCT3 groups:Group 1(A): Hypocaloric diet (1,600 kcal)

with behavior control modificationGroup 2(B): Hypocaloric diet (1,600 kcal)

with behavior control modificationwith previous wt loss program ofVLCD

Group 3(C): Hypocaloric diet (1,600 kcal)with 239 kcal of a supplement

n 7741.6 10 yb

BMI 37.7 4.8b

Mean weight reduction after 26 mo was 7%,10%, and 9.5% in A, B, and C respectively.

Mean weight regain for the 3 groups:(A): 1.7 kg(B): 13.3 kg(C): 13.5 kgNo significant group differences49% attrition

Participants were seen by anurse if problems arose;group sessions were led by adietitian. Assessments andgroups sessions were held ata hospital obesity unit.

Four assessment contacts for allgroups at Months 2, 6, 14, and26.

No data

(continued)

Figure 2. Weight loss maintenance intervention trials: An evaluation using reach, efficacy/effectiveness, adoption, implementation, and maintenance (RE-AIM) dimensions.

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Physical activity and behavior change interventions

Pasman andcolleagues,1999 (22)

12-mo non-RCT2 groups:Endurance training (ET): swim, cycle,

and run 3-4 sessions/wkControl (C): not involved in a training

program

n 1537.3 5.2 y0 womenBMI 30.9 2.8

Weight regain at 12 mo was 65% for the wholegroup (52% for ET and 74% for C); nocorrelation between the training hours perweek and the regain of body weight at 12mo.

3 participants were unwilling to continue thetraining program and were moved to Controlgroup.

Weekly ET sessions weremonitored by a professionalcoach at a triathlon club.

ET: 3-4 weekly enduranceexercise sessions for 1 h

No data

Diet, physical activity, and behavior change interventions

Fogelholmandcolleagues,1999 (12)

6-mo RCT3 groups:Control (C): no increase in habitual

walkingWalk 1 (W1): targeted for 1,000 kcal

weekly expenditureWalk 2 (W2): targeted for 2,000 kcal

weekly expenditure

n 8029-46 yb

80 womenb

BMI 34b

Participationrate: 100%

(C) gained 1.7 kg(W1): lost 0.7 kg(W2): gained 0.2 kg6% attritionEffect size:C-W1: 0.52C-W2: 0.35W1-W2: 0.19

Weekly walking sessions weresupervised by an exerciseinstructor at a clinicalinstitute.

All groups included 6 mo ofweekly group meetings; W1and W2 groups had weeklywalking sessions.

No data

Harvey-Berinoandcolleagues,2002 (13)

12-mo RCT3 groups:Internet support (IS): biweekly chat

sessions, telephone calls and e-mailsent on alternate weeks

In-person support (F-IPS): met in-personbiweekly for 52 wks; telephone callsor e-mail sent on alternate weeks

Minimal in-person support (M-IPS): metin-person monthly for the first 6 mo,then no contact

n 122b

48.4 9.6 yb

104 womenb

BMI 32.2 4.5b

IS gained significantly more wt that the F-IPS.No difference between groups at 2 y.The F-IPS and M-IPS maintained a weight loss

5% (M-IPS: 81.3%, F-IPS: 81%, IS:44.4%).

12% attritionEffect size:IS-MIPS: 0.62IS-FIPS: 0.78FIPS-MIPS: 0.00

Interventions were delivered bygroup therapist and peers.

IS had biweekly internet sessions,F-IPS had in-person biweeklysessions, and M-IPS metmonthly for 1 h during the first6 mo.

Attendance to treatment sessionswere 59% for F-IPS and 39%for IS.

Adherence to self-monitoring was22% for F-IPS and 19% for IS.

No data

Harvey-Berinoandcolleagues,2004 (14)

12-mo RCT3 groupsInternet support (IS): biweekly chat

sessions, phone or emails sent onalternate weeks

Frequent in-person support (F-IPS): metin-person at an interactive television(ITV) studio biweekly for 52 wks;telephone calls or e-mail on alternateweeks

Minimal in-person support (M-IPS): metin-person over ITV monthly for thefirst 6 mo, then no contact.

IS and F-IPS also participated in asocial-influence program

n 23246.0 8.8 y194 womenBMI 29.0 4.4

No differences in weight loss maintained (8.2%IS, 5.6% F-IPS, 6.0% M-IPS)

24% attritionEffect sizee:IS-MIPS: 0.37IS-FIPS: 0.26FIPS-MIPS: 0.05

Interventions were delivered byMS-level dietitians over ITV;assessments completed in aclinical university setting.

IS had biweekly Internet sessionsand alternate week telephoneor e-mail contact, F-IPS hadin-person biweekly sessionsand alternate week phone ore-mail contact, and M-IPS metmonthly for 1 h during the first6 mo.

Participants in the F-IPS attendedsignificantly more groupmeetings compared to those inthe IS group (10 5.1 vs7.7 5.3 meetings attended).

69% of participants provided dataat all assessment points.

No data

King andcolleagues,1989 (16)

12-mo RCT:4 groups:Group 1 (1A): telephone and mail

contact, previous weight loss throughdiet only

Group 1 (1B): telephone and mailcontact, previous weight loss throughexercise only

Group2 (2A): no contact, previousweight loss through diet only

Group 2 (2B): no contact, previousweight loss through exercise only

n 9044.7 7.3 y0 women

Mean weight changes:1A: 3.2 2.9 kg1B: 0.8 3.1 kg2A: 2.6 2.8 kg2B: 3.9 2.8 kgGreater weight maintenance in 1B compared to

1A, 2A, and 2B.20% attritionEffect size:1A-2A: 0.221A-1B: 0.821A-2B: 0.252A-1B: 0.622A-2B: 0.481B-2B: 1.07

ylhtnomdeviecer1puorGatadoNmailings and telephone callslasting 5-10 min at Months 1,2, 3, 6, 9, and 12.

No data

(continued)

Figure 2. Continued

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Kumanyikaandcolleagues2005 (17)

8- to 18-mo RCT3 Groups:Group counseling (GC): 6 meetings

biweekly then monthlyStaff-assisted, self-help (SH): given a

self-directed resource kit, monthlycalls, facilitator support

Clinic visits only (C): no intervention onlysemiannual clinic visit

n 12845.4 10.2 y116 womenBMI 37.0 5.5

Weight regain from baseline to final visit:GC: 0.02 (95% confidence interval 1.7-1.8)SH: 1.1 (95% confidence interval 0.3-2.5)C: 0.04 (95% confidence interval 1.9-1.8)32% attrition

Counseling and intervention wasdelivered at a family practicedepartment of a universityhealth system by a nutrition,exercise, or behavior changespecialist, of whom 45% wereAfrican American.

Cost of the program was $146per person per year.

GC had 6 biweekly meetings,then met monthly thereafter.

Average group session attendancefor GC was 40% for the 6biweekly sessions and 31% forthe monthly sessions.

In SH, the facilitator completed35%-55% of monthlytelephone calls.

No data

Leermakersandcolleagues,1999 (20)

6-mo RCT2 groups:Exercise-focused maintenance (EFM)

program: designed to sustain themaintenance of physical activity

Weight-focused maintenance (WFM)program: sessions focused onmaintenance of weight loss

n 6750.8 11.1 y54 womenBMI 30.8 4.5

No differences between the conditions inexercise participation and energy expenditure.

15% attritionEffect size:EFM-WFM: 0.50

Groups were led by clinicalpsychology graduate students.

Both groups included 6 mo ofbiweekly group counselingsessions.

Participant attendance rates were73.1% for EFM and 70.8% forWFM.

During the 18-mo follow-upvisit, participants in theWFM group had greaterreductions in fat intakeand better maintenanceof weight loss.

28% attritionEffect size 12-18 mo:EFM-WFM: 0.69Effect size 6-18 mo:EFM-WFM: 0.86

Liebbrand andFichter,2002 (21)

18-mo RCT2 groups:Maintenance (M): supportive weight

maintenance program by telephoneconsultation

Control (C): no support

n 10937.1 10.8 y91 womenBMI 44.8 8.7

From baseline-18 mo, BMI increased from42.54 6.74 to 43 7.81 in the M group anddecreased from 40.62 5.67 to 40.58 6.3 inthe C group.

21% attritionEffect size:M-C: 0.02

Interventions were delivered by apsychotherapist; assessmentstook place at a medical clinic.

M received eight 45-mintelephone consultations for 9mo and 4 consultations for thelast 9 mo, then invited to a 2-dtherapist-guided boostersession.

No data


12-mo RCT:3 groups:Control (BT): no contactRelapse prevention therapy (RPT) (7):

group sessions for relapse preventionProblem solving therapy (PST) (25):

group sessions for problem solving

n 8046.6 8.9 yb

80 womenb

BMI 35.8 4.5b

Weight regain from baseline-12 mo:BT: 5.39 kgRPT: 2.56 kgPST: 1.51 kg28% attritionEffect size 5-11 mo:BT-RPT: 0.94BT-PST: 1.22RPT-PST: 0.29Effect size 11-17 mo:BT-RPT: 0.32BT-PST: 0.57RPT-PST: 1.0

rofdeludehcserewTSPdnaTPRatadoN6 biweekly sessions.

Audiotape recordings were usedto examine protocol delivery. InRPT, 100% of relapseprevention skills were observedand 0% of problem solvingskills were observed. In PST,100% of the problems solvingskills were observed and 33%of the relapse prevention skillswere observed. Adherence toprogram goals decreased overtime; this differed between BTand PST.

No data


12-mo RCT3 groups:Group 1(A): extended care, telephone

counseling sessionsGroup1(B): extended care, face-to-face

counseling sessionsGroup 2 (C): education control group,

which received newsletters

n 23459.4 6.1 y234 womenBMI 36.8 4.9

A and B regained less weight than Group C(1.2 0.7 kg and 1.2 0.6 kg vs 3.7 0.7 kg),and had greater adherence to behavioralweight maintenance strategies.

6% attritionEffect size:A-B: 0.00A-C: 0.42B-C: 0.43

Participant contacts were led byCooperative ExtensionServices (CES) agents with abachelor’s or master’s degreein nutrition, exercisephysiology, or psychology; inrural CES offices.

Costs to program (perparticipant):

A: $192 21B: $391 73C: $116 19Costs to participant:A: $1,933 1,436B: $2,157 1,449C: $1,708 1,692

A and B received 26 biweeklycounseling sessions, A received15-20 min sessions and Breceived 60-min sessions. Creceived 26 biweekly mailnewsletters. Sessions werebased on Perri’s 5-stageproblem solving model (25).

A and B’s mean number ofsessions attended were13.8 8.6 and 21.1 5.7,respectively.

No data

(continued)

Figure 2. Continued

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Reach Efficacy/effectiveness Adoption Implementation Maintenance

Riebe andcolleagues,2005 (26)

18-mo RCT2 Groups:Extended care group (EC): received

additional personalizedTranstheoretical Model reports

Control (C): received generic materialsabout diet/exercise. Both groupsreceived reports on anthropometrics,biochemical, and dietary intake

n�14450.2�9.2 yBMI 32.5�3.8

Mean weight change from baseline to 24 mo:EC: 87.6�15.9 kg to 90.5�16.9 kgC: 84.1�14.1 kg to 86.9�15.4 kgNo significant differences in weight change

between groups.

A registered dietitian reviewedfood records.b

Both groups received mailedreports at 6 and 18 mo, ECreceived mailed reports basedon the Transtheoretical Modelof Health Behavior Change atMonth 3 and 9.

Both groups received afollow-up assessment at18 mo.

32% attrition

Svetkey andcolleagues,2008 (11)

30-mo RCT3 groups:Personal contact (PC): monthly

telephone and every fourth monthface-to-face counseling

Interactive technology-basedintervention: participants wereencouraged to regularly log on to aninteractive Web site

Self-directed (control) (25): minimalintervention

n�1,03255.6�8.7 y654 womenBMI 34.1�4.8

PC regained 4.0 kgITI regained 5.2 kgSD regained 5.5 kg71% of study participants remained below entry

weight.PC regained less weight as compared to SD.No difference between PC and ITI6.6% attritionEffect size:SD-ITI: 0.05SD-PC: 0.27PC-ITI: 0.27

Clinical university setting 30 monthly contacts for PCgroup, duration of 5-15 mineach, and every fourth monthduration was 45-60 min.

No data

Wing andcolleagues,1996 (29)

Study 1: 12-mo RCT2 groups:Group 1 (G1): telephone-assisted weight

maintenance and access to anutritionist for further counseling

Group 2 (G2): no-contact

n�5343.6�1.5 y53 womenBMI 32.2�0.4

G1 had a weight gain of 3.9�1.1 kg vs aweight gain of 5.6�1.0 kg in G2.

15% attritionEffect size:G1-G2: 0.33

Telephone calls were completedby a trained interviewer in auniversity clinic.

Participants were called everyweek for 15 min for theduration of the study; 80% ofthe calls were completed.

92% of participants were able toself-report weight, 58% selfreported food logs, and 62%self-reported exercise logs.

No data

Wing andcolleagues,1996 (29)

Study 2: 12-mo RCTGroup 1 (G1): could purchase food

boxes during any 4 mo of programGroup 2 (G12): no food provisions

n�4840.7�1.5 y48 womenBMI 32.4�0.4

G1 had a weight gain of 4.2�1.0 kg vs aweight gain of 4.3�1.1 kg in G2.

Only 12 participants ordered food provisions.0% attritionEffect size:G1-G2: 0.02

Participants were weighed anddiscussed problems with atherapist.

Both groups were seen monthlyfor group sessions for theduration of the study.

No data

aRCT�randomized control trial.bRepresents data from the weight loss phase. No data were provided for only the weight maintenance phase of the intervention.cVLCD�very-low-calorie diet.dBMI�body mass index.eEffect size calculated from the mean�standard deviation of the change in weight (in kilograms) from baseline of weight loss phase to post intervention of weight maintenance phase. No data was reported for weight change from baselineof weight maintenance phase to post intervention of weight maintenance phase.

Figure 2. Continued

October2010

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42%

68%

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79%

74%

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11%

5%

0%

37%

0%

21%

95%

5%

63%

37%

89%

0%

63%

0%

0%

0%

0%

11%

0%

16%

95%

95%

58%

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68%

11%

16%

16%

0%

0%

Descrip�on of target popula�on

Par�cipant demographic & behavioral informa�on

Method to iden�fy target popula�on

Recruitment strategies

Inclusion criteria

Exclusion criteria

Target popula�on denominator

Sample size

Par�cipa�on rate

Characteris�cs of both par�cipants and nonpar�cipants

Cost of recruitment ac�vi�es

Primary outcome measures

Primary outcome results

Imputa�on procedures

Quality of life measures

Measure of poten�al nega�ve outcomes

Percent a�ri�on

Cost effec�veness

Descrip�on of interven�on se�ngs

Descrip�on of interven�on loca�on

Descrip�on of staff who delivered interven�on

Method to iden�fy target delivery agent

Level of exper�se of delivery agent

Inclusion/exclusion of se�ngs or interven�onist

Se�ng level par�cipa�on rate

Spread to addi�onal loca�ons within the organiza�on

Characteris�cs of se�ngs that adopt and those that do not

Measure of cost of adop�on

Dissemina�on beyond originally planned

Iden�fied underlying interven�on theory

Interven�on number of contacts

Timing of contacts

Dura�on of contacts

Extent protocol delivered as intended

Par�cipant a�endance/comple�on rates

Measure of cost

A�ri�on

Sustained weight loss maintenance post interven�on

Informa�on on con�nued delivery

Informa�on on program sustainability

Percent of Studies that Reported Informa�on on Specific RE -AIM Indicators

0 10 20 30 40 50 60 70 80 90 100

Indicators by RE-AIM dimension

100%

100%

100%

RE-AIM dimensions

Reach

Efficacy/effec�veness

Adop�on

Implementa�on

Maintenance

igure 4. Reach, efficacy/effectiveness, adoption, implementation, maintenance (RE-AIM) framework dimensions and individual indicators using the
E-AIM Coding Sheet to identify gaps in existing weight loss maintenance interventions.

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hange) are presented in Figure 2. Although half of therticles provided information addressing three RE-AIMimensions (reach, efficacy/effectiveness, and implemen-ation), few reported information addressing the adoptionnd maintenance dimensions (Figure 4). Results acrossE-AIM dimensions are summarized as follows:each. Only seven (37%) articles reported more than 50%f the reach dimension indicators, with the top two indi-ators reported being sample size (100%) and inclusionriteria (79%). The median number of participants was03 and only two studies reported participation rates78% and 100%). Finally, only one study reported on theepresentativeness of the study participants relative tohe target population. No articles reported cost of recruit-ent or target population denominator.

ffectiveness/Efficacy. Fifty-one percent of the effective-ess/efficacy indicators were reported across weight lossaintenance studies with the top three indicators beingeasures used (100%), results (100%), and percent attri-

ion (95%). Median attrition rates across follow-ups were1%. Although a small proportion of the studies reportedracking unintended or negative consequences (21% re-orting) and cost effectiveness (5%), no articles reportedn quality of life. Of the studies reviewed, the most effec-ive weight loss maintenance interventions were group-ased behavioral treatments (relapse prevention trainingnd problem-solving therapy) (25) and telephone andail personal information contacts with individuals thatad previously lost weight through an exercise-only in-ervention (16). The average duration of the weight main-enance intervention was 12.6 months; weight regain wasore likely reported with interventions including onlyypocaloric diets and supplements after a very-low-en-rgy diet weight loss trial (27,28). In addition, the highestttrition (65%) was reported in a very-low-energy trial18).doption. Only about one fourth of the adoption dimensionndicators were reported, with most studies reporting aescription of staff who delivered the intervention (89%).nly six studies reported using registered dietitians as

ntervention delivery personnel. No articles reportedethods used to identify target delivery agent, inclusion/

xclusion of settings or interventionist, rate of participa-ion, organizational spread, characteristics of adoption/on-adoption, or dissemination.

mplementation. Along with effectiveness, this RE-AIM di-ension was most frequently reported across studies re-

iewed. More than 59% of implementation indicatorsere coded with the top two indicators reported being

ntervention number (95%) and timing of participant con-acts (95%). The least likely to be reported in this sampleere measures of cost, theoretical constructs used as theasis of intervention, and extent of the protocol that waselivered as intended.aintenance. This RE-AIM dimension was least fre-uently reported throughout the sample, representing.9% of the maintenance indicators. Only three articles16%) addressed any indicators in the maintenance di-ension; they were behaviors assessed after the comple-

ion of the weight loss maintenance intervention (16%)
nd percent attrition at that assessment (16%). n
ISCUSSIONhe field of inquiry within weight loss maintenance is aibrant research area that could significantly influenceopulation health. However, within the context of at-empting to develop weight loss maintenance interven-ions that have the potential for translation into regularractice, it is critical to address, evaluate, and under-tand the extent to which interventions have the poten-ial to reach a large proportion of the target population,e effective, align with the available delivery system re-ources, and be sustainable (53). This analysis, as well asthers (32,33), identified numerous effective weight lossaintenance interventions. However, in contrast to pre-

ious reviews in this area, we have identified significantaps in important factors related to external validity (eg,osts, adoption, and representativeness) and metrics thatould facilitate the translation of research interventionso practice settings. To date, it remains largely unknownow effective weight loss maintenance interventions are

n real-world situations, such as clinical or communityractice settings.Often, behavioral interventions do not reach those who

ould benefit most, they show reduced effectiveness overime, and they do not address setting-related issues nec-ssary to ensure institutionalization and sustainability ofontent delivery at the organizational level (37). It isncertain whether weight loss maintenance interventionesearch suffers from these same limitations, yet thesendings confirm that the reporting of external validity

nformation is greatly lacking. Of all of the studies re-iewed, the one reporting the most information acrossE-AIM dimensions still reported only about half of the

ndicators evaluated in this review (17). Although ourtudy provided an exceptionally detailed overview ofeach, efficacy, and implementation dimensions, thereas still little information provided on potential adoption

r sustainability.In comparison to other reviews based on the RE-AIM

ramework, the weight loss maintenance literature is re-arkably consistent (37,52,54-56). Specifically, we found

hat only 5% of studies on weight loss maintenance re-orted on participant representativeness. This finding isonsistent with the gap in the literature on general phys-cal activity, nutrition, and smoking cessation interven-ions (ie, 14% of studies reported representativeness37]), physical activity interventions for cancer survivorsie, no studies reported [52]), and interventions to preventhildhood obesity (ie, 10% of studies reporting [56]). It islso of note that the proportion of weight loss mainte-ance trials that reported on quality of life outcomes (ie,o studies reported in our review) is similar to the pro-ortion found in a review of 119 studies on physicalctivity, nutrition and smoking cessation across school,ommunity, health care, and work site settings (ie, 7% oftudies reported on quality of life [37]). In contrast, aboutthird of the studies examining the prevention of child-

ood obesity report on quality of life outcomes (56).Also missing across the extant literature represented

cross RE-AIM reviews is consistent reporting of setting-evel representativeness, cost, setting-level maintenance,nd—to a lesser extent—the reporting of the degree tohich an intervention is delivered as intended. Indeed,
o studies in our review and only two studies across other

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E-AIM reviews (37,56) report on setting-level represen-ativeness and potential for maintenance. Eleven percentf studies in our review reported on cost issues. Thisuggests that compared to other physical activity, nutri-ion, and smoking cessation trials that the weight lossaintenance literature has a lower attendance to cost.lasgow and colleagues (37) found about one third of the

tudies they reviewed included some information on cost.inally, the weight loss maintenance literature seems toe less likely to report on the degree to which an inter-ention is delivered as intended (ie, about 16% of studies)hen compared to other reviews where, on average, more

han half of the studies reviewed contained such informa-ion (37,52,54-56).

Based on this evaluation and others (37,43,47,57,58), aumber of recommendations may be considered for futureeight loss maintenance research to better align with theE-AIM framework:each. Only sample size was reported with unanimousonsistency across studies and reach dimensions. Notudy provided a denominator from which to calculateroportional reach. When participation rate was calcu-ated it was typically done so as a proportion of peopleho follow-up on the advertisements, who ultimatelyere eligible, and enrolled in the study. When reportingn the reach of an intervention, it is recommended thatuthors provide a brief definition of the intended popula-ion and a proportional value that reflects the penetrationf the intervention into the target population. For mostfficacy trials the concern is recruiting enough partici-ants to provide the necessary power to detect changesetween groups; yet understanding the number of poten-ial participants that were exposed to recruitment mate-ials can provide a rough estimate of the likely reach therogram will achieve. Collecting demographic informa-ion on both those who agree to participate and those whoecline participation would provide information on sub-roups within the population who may not be representedn the study sample.fficacy/Effectiveness. Although all studies reported inter-ention outcomes, no study examined quality of life, 42%sed intent-to-treat analyses rather than present at fol-

ow-up. Understanding quality of life in response toeight loss maintenance interventions could provide in-

ormation that can be used to enhance participant en-agement, or to determine whether a given interventions successful in maintaining weight loss maintenance butlso influences quality of life.doption. Few effectiveness trials have been conducted tochieve weight loss maintenance; that is, efficacy trialsre prevalent. Thus, it is not surprising that adoptionndicators are almost exclusively absent beyond describ-ng where the study is taking place and the interventiontaff who deliver the program. As only 23% of the adop-ion indicators were coded across weight loss mainte-ance studies, an increased focus on balanced reportingf internal vs external validity indicators would provideeaningful information related to the applicability of a

iven intervention across settings and those deliveringhe interventions. Information on why certain deliveryocations and staff were selected should also be
resented. s

mplementation. Intervention contact and duration wasrequently reported, and approximately 73% (n�14) oftudies reported participant adherence to sessions. Inontrast, only one in five studies reported the underlyingheoretical approach to intervention development. Be-ause theory provides an understanding of the principlesy which an intervention is thought to achieve its effect53), the specific theory or theoretical constructs used inhe intervention should be reported. The extent to whichhe intervention was delivered as intended should also bencluded.aintenance. Despite the research focus on weight main-

enance, weight loss maintenance studies did not ofteneport on the sustainability of effects once the interven-ion was complete, attrition, or potential for the programso be sustained in regular practice. This issue would be ofignificant interest to practitioners. Thus, it would beeneficial for weight loss maintenance research studies tonclude follow-up assessments after the intervention isomplete, to determine the sustainability of weight lossaintenance and other lifestyle behaviors beyond the

ctual intervention period.ost. Measures of cost of recruitment and effectivenessere absent within the reviewed literature, and �10% of

he articles reviewed examined cost of implementation ordoption. We acknowledge that modeling costs across theE-AIM dimensions is a field of scientific inquiry in andf itself. However, it is possible for researchers to trackosts and report the figures within their work (see refer-nce 23 for an excellent example). Understanding the costf an intervention across these dimensions would likelylso be highly valued in the practice setting. Thus, studyrotocols should assess costs across the research processrom recruitment through the implementation process,nd include this data when reporting intervention effects.

ONCLUSIONSor practitioners like Paula depicted in our vignette, the

nternal as well as the external validity in studies shoulde evaluated to determine the most appropriate weightoss maintenance intervention for a particular practiceetting. Examining research and selecting interventionshat include a broad heterogenous sample and definedopulation, consideration of program delivery personnel,osts, and a feasible intervention design will increaseikelihood of success when attempting to translate pro-rams into clinical and community settings.The need to translate successful weight loss mainte-

ance interventions into practice is clear. The Nationalnstitutes of Health has numerous grant opportunitiesor funding and planning of translational research, in-luding research addressing weight loss maintenance.pecific to weight loss maintenance research, futurerojects should be planned to address how the programill be adopted and maintained with special attention to

osts related to participants and program implementa-ion, which were identified as limitations in currenteight loss maintenance literature. Translational re-

earch addressing these limitations will begin to bridgehe gaps between long-term weight loss maintenance re-
earch and practice.

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TATEMENT OF POTENTIAL CONFLICT OF INTEREST:o potential conflict of interest was reported by the au-

hors.FUNDING/SUPPORT: The corresponding author

B.M.D.) is supported by National Institutes of Healthrant no. K01 DK075424.

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http://www.re-aim.org/

Fm

Coding Sheet for Publications Reporting on RE-AIM Elements

Title: GroupBased Individual Interactive

technology Policy Environment

(Author, Journal, Year, Page): Comments:

Outcome Measures:Primary Outcomes: Behavioral Physical

activity Diet

REACH Reported(Yes/No) Data Comments

Described Target Population

Demographic & behavioral information

Method to identify target population

Recruitment Strategies

Inclusion criteria

Exclusion criteria

Target population denominator

Sample size

Participation rate

Characteristics of both participation and non-participation

Cost of recruitment

EFFICACY/EFFECTIVENESS Design Conditions

Design/Conditions

Efficacy, Effectiveness, Translational?

Measures

Results (at shortest assessment)

igure 3. Reach, Efficacy/effectiveness, Adoption, Implementation, Maintenance (RE-AIM) Coding Sheet used to code published weight loss
aintenance research.
October 2010 ● Journal of the AMERICAN DIETETIC ASSOCIATION 1522.e1

F

1

Imputation procedures (specify)

Quality of life measure

Measure unintended consequences (negative) & Results

Percent attrition

Cost effectiveness

ADOPTION - DIFFUSION - Setting Level Reported(Yes/No) Data Comments

Setting

Description of intervention location

Description of staff who delivered intervention

Method to identify target delivery agent

Level of expertise of delivery agent

Inclusion/exclusion criteria of settings or interventionist

Rate (#participating settings/total settings)

Organizational spread (how far into an organization)

Characteristics of adoption/non-adoption

Measures of cost of adoption

Dissemination beyond originally planned

Intent-to-treator present at FU (circle one)

igure 3. Continued

522.e2 October 2010 Volume 110 Number 10

F

Duration of contacts

Extent protocol delivered as intended (%)

Participant attendance/completion rates

Measures of cost

MAINTENANCE Reported(Yes/No) Data Comments

Was individual behavior assessed at some duration following the completion of the intervention?(give duration of follow-up)

Attrition

Is the program still in place?

If no: reason for discontinuation

If yes: was the program modified? Specify

Was the program institutionalized?

Note related studies (e.g., other outcomes or process)

IMPLEMENTATION Reported(Yes/No) Data Comments

Theories

Intervention number of contacts

Timing of contacts

igure 3. Continued

October 2010 ● Journal of the AMERICAN DIETETIC ASSOCIATION 1522.e3

Documents

Translational Research: Bridging the Gap between Long-Term Weight Loss Maintenance Research and Practice