Clinical trial NCT00460018: Diet, Exercise, and Breastfeeding Intervention Program for Women With Gestational Diabetes (DEBI Trial)
Official title: Diet, Exercise and Breastfeeding Intervention (DEBI) Program for Women With Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gestational Diabetes Mellitus
Keywords: Gestational Diabetes Mellitus
Weight Loss
Physical Activity
Breastfeeding
Pregnancy
Postpartum
Intervention
Prevention
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2007-04-13
Enrollment: 180
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postpartum weight retention
timeFrame: no more than 1.5 years
Secondary outcomes:
measure: reduced plasma glucose levels (measured at 6 weeks and 1 year postpartum)
timeFrame: 1 year
measure: levels of plasma insulin
timeFrame: 1 year
measure: markers of insulin resistance
timeFrame: 1 year
measure: adiponectin
timeFrame: 1 year
measure: dietary fat
timeFrame: no more than 1.5 years
measure: physical activity
timeFrame: no more than 1.5 years
measure: breastfeeding duration
timeFrame: no more than 1.5 years
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Kaiser Permanente Oakland
state: California
city: Oakland
country: United States
facility: Kaiser Permanente Division of Research
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente San Francisco
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente Santa Clara/Santa Teresa
state: California
city: Walnut Creek
country: United States
facility: Kaiser Permanente Walnut Creek
state: California
Study officials:
affiliation: Kaiser Permanente Division of Research
name: Assiamira Ferrara, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.