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ter can be downloaded from
www.fda.gov/ cdrh/psn/show16-
Nellcor.html. The supplement should
be retained for reference with the Fetal
Heart Monitoring Principles and
Practices (3rd ed.)
textbook.
A second printing of the third-edi-
tion Fetal Heart Monitoring Principles
and Practices textbook that includes all
corrections and supplement updates
was scheduled for release in September
2003. The second printing will be easi-
ly identified as such on the reverse of
the inside cover page.
FDA Proposing Revisionsfor Blood Storage
The Food and Drug Administra-
tion (FDA) is proposing to revise
the labeling and storage requirements
for certain human blood and blood
components, including source plasma,
by combining, simplifying and updat-
ing specific regulations applicable to
container labeling and instruction cir-
culars, and the shipping and storage
temperatures for frozen noncellular
blood components.
This proposed rule would facilitate
the use of a labeling system using
machine-readable information that
would be acceptable as a replacement
for the “ABC Codabar” system for
labeling blood and blood components.
FDA is taking this action as part of its
“Blood Initiative” to comprehensively
review and, as necessary, revise its reg-
ulations, policies, guidances and pro-
cedures related to the licensing and
regulation of blood products. This
proposed rule is intended to help
ensure the continued safety of the
blood supply and to help ensure con-
sistency in container labeling and stor-
age temperatures.
Submit written or electronic com-
ments on the proposed rule by
October 28, 2003. See section VIII of
this document for the proposed effec-
tive date of a final rule based on this
document. To access the ruling, go to
http://frwebgate.access.gpo.gov/
cgibin/leaving.cgi?from=leavingFR.
html&log=linklog&to=http://www.fda.
gov/dockets/ecomments.
National Test Trial Set forDiabetes Community
The National Diabetes Education
Outcomes System (NDEOS),
which was recently previewed at the
American Association of Diabetes
Educators (AADE) Annual Meeting &
Exhibition, is being launched to stan-
dardize measurement of outcomes in
diabetes care and education.
Diabetes is a costly chronic disease.
In the U.S. alone, recent statistics
report 17 million persons with dia-
betes; the Centers for Disease Control
and Prevention predict a continued
sharp increase in these already acceler-
ated rates. The diabetes community,
patients and educators, are feeling the
pressure from Medicare, third party
payers and administrators to provide a
more thorough reporting of specific
outcomes related to diabetes educa-
tion. Validation of improved patient
behaviors, such as eating habits, physi-
cal activity, blood glucose monitoring
and medication administration, is
required in order to demonstrate out-
comes. Diabetes care and education
team members can now use the
NDEOS to aid in this necessary
process.
Successful treatment of diabetes
requires the partnership of the
patient, clinician and the diabetes edu-
cator. With this new system, diabetes
educators have a complete solution to
gather, track and aggregate patient
outcomes while integrating the prac-
tice of diabetes education and clinical
care.
AADE reports that testing of the
new system will take place from
August 2003 to February 2004 in 500
to 1,000 patients at seven diabetes edu-
cation sites throughout the U.S. It has
projected that NDEOS will be available
to the entire diabetes education com-
munity by March 2004.
Testing Ways to KeepWeight Off
The National Heart, Lung, and
Blood Institute (NHLBI) has
announced the launch of a major
study that could help solve one of the
hardest aspects of weight loss—keep-
ing off lost pounds. The study, called
the “Weight Loss Maintenance Trial,”
will be done in two phases at four clin-
ical sites.
The study will include 1,600 men
and women in its first phase, and 800
in its second. Phase I is a five-month
weight loss program; Phase II will try
to help those who lose nine or more
pounds in Phase I keep the weight off
for two and a half years.
The study has begun seeking par-
ticipants, who must be overweight or
obese, age 25 or older, and taking
medication to control high blood pres-
sure and/or high blood cholesterol.
About 60 percent will be women and
40 percent will be African American.
Overweight/obesity is the second
leading cause of preventable death in
the U.S. Overweight and obesity
increase the risk of heart disease and
other conditions, including high blood
pressure, high blood cholesterol, dia-
betes, stroke and some cancers.
About 65 percent of American
adults—about 129 million persons—
are overweight or obese, and the
prevalence is increasing. In 1988-94,
almost 60 percent of American adults
were overweight or obese, while in
1999 to 2000, nearly 65 percent were
overweight or obese.
The four centers involved in the
Weight Loss Maintenance study are
• Duke University
October | November 2003 AWHONN Lifelines 453
• Pennington Biomedical Research
Center at Louisiana State University
in Baton Rouge
• Permanente Center for Health
Research (KPCHR) in Portland, OR
• The Johns Hopkins Medical Institu-
tions in Baltimore, MD
In the study’s first phase, participants
will receive counseling to help them
make lifestyle changes to reduce their
weight. These lifestyle changes will
include reducing calories and increas-
ing physical activity. Participants will
be encouraged to follow the DASH
eating plan, which has been shown to
reduce blood pressure and cholesterol.
DASH is high in fiber and low in satu-
rated fat, cholesterol and total fat, and
emphasizes fruits, vegetables and low-
fat dairy foods. Phase I participants
will keep food and fitness diaries to
monitor their diet and physical activi-
ty. Those who lose nine or more
pounds after five months will be eligi-
ble to enroll in phase II.
In phase II, participants will be ran-
domly assigned to one of three weight-
maintenance strategies: self-directed/
usual care (SD/UC), personal contact
(PC), and interactive technology (IT).
The SD/UC group will meet once with
a health counselor for advice on how
to maintain their weight loss and to
discuss their own weight loss plans.
They also will receive educational mate-
rials about diet and physical activity.
Those in the PC group will receive
personal guidance and counseling on
how to maintain their weight loss
through monthly telephone calls and
occasional visits with a health coun-
selor.
Participants in the IT group will
use an Internet-based, individually tai-
lored, interactive computer program to
help them keep their weight off. They
can use the program as often as they
wish and can log on anywhere they
have Internet access: at home, work, a
school or a public library. They also
will receive weekly e-mails with tai-
lored messages on their progress that
include links to the Web site.
Furthermore, they will receive
reminders by an interactive voice
phone system to log onto the study’s
Web site and respond to e-mail.
Those interested in finding out
about enrolling in the study can call
the site near them:
for Duke University, (919) 419-5904;
for Pennington, (225) 763-2596;
for Kaiser Permanente, (503) 499-5766;
for Johns Hopkins, (410) 281-1881.
454 AWHONN Lifelines Volume 7 Issue 5
Get your next meeting or educational session listed in AWHONN Lifelines by faxing your informa-tion to: AWHONN Lifelines—Save These Dates: (970) 947-9784 or email [email protected] are included on a space-available basis.
Save These Dates!
DATE LOCATION EVENT
10/10-13 Los Angeles, CA Women's Health Practice Update and Certification Preparation Course; UCLA Research & Education Institute; contact www.womenshealthnp.org
10/15 London, Canada Breast Feeding Challenges: Complex Clinical Issues; contactMargret Duncan at (519) 685-8300 ext. 52954 or e-mail [email protected]
10/16-18 Mississauga, Canada Building Brighter Futures; AWHONN Canada Conference; contact Sue Bookey-Bassett at [email protected]
10/24 Miami, FL Improving Health Care Qualitythrough Research; Florida International University School ofNursing; contact JoAnne Youngblut at (305) 919-5845 [email protected]
11/2 Newport, OR Annual Fall Conference; AWHONN Oregon Section; contact Jane Wilson at [email protected] or (503) 215-5027
11/2-7 Santiago, Chile XVII FIGO World Congress of Gynecology & Obstetrics; www.figo2003.com
11/7-8 Toronto, Canada Breastfeeding Conference; Contact Joyce Ridge, Mount Sinai Hospital, (416) 586-3238
6/26-30, 2004 Tampa, FL Challenging the Status Quo, the AWHONN 2004 Convention, www.awhonn.org
On-going Call for location Challenging the Status Quo, theAWHONN 2004 Convention; www.awhonn.org
On-going Call for location The AWHONN Fetal Heart Monitor-ing Principles and Practices Workshop; www.awhonn.org
