Diet, Exercise, and Breastfeeding Intervention Program for Women With Gestational Diabetes (DEBI Trial)
DEBI
Diet, Exercise and Breastfeeding Intervention (DEBI) Program for Women With Gestational Diabetes
2 other identifiers
interventional
180
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 11, 2007
CompletedFirst Posted
Study publicly available on registry
April 13, 2007
CompletedJune 19, 2009
January 1, 2009
April 11, 2007
June 18, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postpartum weight retention
no more than 1.5 years
Secondary Outcomes (7)
reduced plasma glucose levels (measured at 6 weeks and 1 year postpartum)
1 year
levels of plasma insulin
1 year
markers of insulin resistance
1 year
adiponectin
1 year
dietary fat
no more than 1.5 years
- +2 more secondary outcomes
Study Arms (2)
Intervention
EXPERIMENTALWomen receiving the DEBI Intervention
No intervention
NO INTERVENTIONWomen receiving standard care
Interventions
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)
Eligibility Criteria
You may qualify if:
- Diagnosis of Gestational Diabetes Mellitus
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Kaiser Permanente Oakland
Oakland, California, 94611, United States
Kaiser Permanente Division of Research
Oakland, California, 94612, United States
Kaiser Permanente San Francisco
San Francisco, California, 94115, United States
Kaiser Permanente Santa Clara/Santa Teresa
Santa Clara, California, 95051, United States
Kaiser Permanente Walnut Creek
Walnut Creek, California, 94596, United States
Related Publications (6)
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.
PMID: 1748259BACKGROUNDTuomilehto 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.
PMID: 11333990BACKGROUNDKnowler 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.
PMID: 11832527BACKGROUNDO'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.
PMID: 14709187BACKGROUNDLeermakers 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.
PMID: 9822949BACKGROUNDFerrara 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.
PMID: 21540430DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Assiamira Ferrara, MD, PhD
Kaiser Permanente Division of Research
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 11, 2007
First Posted
April 13, 2007
Study Start
September 1, 2005
Last Updated
June 19, 2009
Record last verified: 2009-01