Diet, Exercise, and Breastfeeding Intervention Program for Women With Gestational Diabetes (DEBI Trial) (DEBI)
June 18, 2009 updated by: Kaiser Permanente
Diet, Exercise and Breastfeeding Intervention (DEBI) Program for Women With Gestational Diabetes
The primary aim of this study is to evaluate whether a lifestyle intervention of diet, exercise, and breastfeeding is associated with decreased postpartum weight retention and reduced plasma glucose levels, measured at 6-weeks and 1-year postpartum, among women with gestational diabetes mellitus (GDM).
Secondary outcomes are postpartum levels of plasma insulin, markers of insulin resistance, adiponectin, dietary fat, physical activity, and breastfeeding duration.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Postpartum predictors of type 2 diabetes incidence in women with GDM are pregnancy weight retention and postpartum weight gain.
By promoting physical activity and appropriate diet during pregnancy and soon after delivery, and preventing excessive pregnancy weight gain and postpartum weight retention, the postpartum incidence of obesity and type 2 diabetes might be reduced or delayed in GDM women.
We are implementing and evaluating a lifestyle intervention of diet, physical activity, and breastfeeding among women with GDM.
The diet and physical activity elements of the intervention are similar to the DPP-Follow-up study.
All participants have GDM by plasma glucose levels measured during a standard 100-g, 3-h OGTT according to the ADA and the ACOG criteria and have no contraindications to participating in a diet and physical activity program.
At study entry, eligible women are randomly assigned to life-style intervention or usual medical care.
The intervention starts during pregnancy and continues for one year postpartum.
It consists of structured, individually tailored, in-person sessions and telephone calls with a lactation consultant and a life-style coach.
The goals of the intervention during pregnancy are to help GDM women comply with the Institute of Medicine guidelines for weight gain by following the ADA and ACOG recommendations for physical activity and diet.
After pregnancy, the goals of the intervention are to help women exclusively breastfeed for at least six months and reach their pre-pregnancy weight.
For those women who were overweight or obese prior to pregnancy, the additional goal of a reduction in weight of at least 5% of their pre-pregnancy weight is also set.
For the maintenance phase of the intervention, beginning at 8 months postpartum, the intervention women receive tailored written materials in the mail and telephone calls reinforcing the positive changes they have adopted.
All participants have follow-up clinic visits at 8-week, 8-month, 12-month, 18-month, and 24-month after delivery.
Data analyses will be by intent-to-treat.
Demographics, psychosocial and behavioral factors that may be related to success at achieving the postpartum weight goals and the secondary postpartum outcomes will be examined.
Study Type
Interventional
Enrollment (Anticipated)
180
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Oakland, California, United States, 94611
- Kaiser Permanente Oakland
-
Oakland, California, United States, 94612
- Kaiser Permanente Division of Research
-
San Francisco, California, United States, 94115
- Kaiser Permanente San Francisco
-
Santa Clara, California, United States, 95051
- Kaiser Permanente Santa Clara/Santa Teresa
-
Walnut Creek, California, United States, 94596
- Kaiser Permanente Walnut Creek
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Diagnosis of Gestational Diabetes Mellitus
Exclusion Criteria:
- Ever diagnosed with diabetes when not pregnant
- Ever diagnosed with cardiovascular disease
- Ever diagnosed with lung disease
- Hemoglobin < 9.5 mg/dl
- Hematocrit less than 30%
- SBP >= 140 or DBP >= 90 in the last month
- Diagnosis of thyroid disease in the last month
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Women receiving the DEBI Intervention
|
Phase I (Pregnancy Program from GDM diagnosis to delivery): One in-person session with the lifestyle coach, two phone calls with the lifestyle coach, and one in-person session with the lactation consultant Phase II (Early Post-partum Period from delivery to 6 weeks post-partum): Two to four routine phone calls with the lactation consultant Phase III (Late Post-partum Period 6 weeks to 7 months postpartum): Two in-person sessions with the lifestyle coach, up to 11 phone calls with the lifestyle coach, and two to three routine calls with the lactation consultant Phase IV (Maintenance Phase 8 months to 1 year postpartum): One newsletter from the lifestyle coaches, two recipe letters and continue calls with the lifestyle coach (optional)
Other Names:
|
|
No Intervention: No intervention
Women receiving standard care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Postpartum weight retention
Time Frame: no more than 1.5 years
|
no more than 1.5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
adiponectin
Time Frame: 1 year
|
1 year
|
|
reduced plasma glucose levels (measured at 6 weeks and 1 year postpartum)
Time Frame: 1 year
|
1 year
|
|
levels of plasma insulin
Time Frame: 1 year
|
1 year
|
|
markers of insulin resistance
Time Frame: 1 year
|
1 year
|
|
dietary fat
Time Frame: no more than 1.5 years
|
no more than 1.5 years
|
|
physical activity
Time Frame: no more than 1.5 years
|
no more than 1.5 years
|
|
breastfeeding duration
Time Frame: no more than 1.5 years
|
no more than 1.5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Assiamira Ferrara, MD, PhD, Kaiser Permanente Division of Research
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.
- Tuomilehto J, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M, Salminen V, Uusitupa M; Finnish Diabetes Prevention Study Group. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001 May 3;344(18):1343-50. doi: 10.1056/NEJM200105033441801.
- O'Toole ML, Sawicki MA, Artal R. Structured diet and physical activity prevent postpartum weight retention. J Womens Health (Larchmt). 2003 Dec;12(10):991-8. doi: 10.1089/154099903322643910.
- Metzger BE. Summary and recommendations of the Third International Workshop-Conference on Gestational Diabetes Mellitus. Diabetes. 1991 Dec;40 Suppl 2:197-201. doi: 10.2337/diab.40.2.s197. No abstract available.
- Leermakers EA, Anglin K, Wing RR. Reducing postpartum weight retention through a correspondence intervention. Int J Obes Relat Metab Disord. 1998 Nov;22(11):1103-9. doi: 10.1038/sj.ijo.0800734.
- Ferrara A, Hedderson MM, Albright CL, Ehrlich SF, Quesenberry CP Jr, Peng T, Feng J, Ching J, Crites Y. A pregnancy and postpartum lifestyle intervention in women with gestational diabetes mellitus reduces diabetes risk factors: a feasibility randomized control trial. Diabetes Care. 2011 Jul;34(7):1519-25. doi: 10.2337/dc10-2221. Epub 2011 May 3.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Study Registration Dates
First Submitted
April 11, 2007
First Submitted That Met QC Criteria
April 11, 2007
First Posted (Estimate)
April 13, 2007
Study Record Updates
Last Update Posted (Estimate)
June 19, 2009
Last Update Submitted That Met QC Criteria
June 18, 2009
Last Verified
January 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CN-04AFerr-04-H
- CN-03AFerr-02
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