Diet, Exercise, and Breastfeeding Intervention Program for Women With Gestational Diabetes (DEBI Trial)

Completed · Phase 2

Conditions studied: Gestational Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT00460018

Run by

Kaiser Permanente

People needed

180

Starts

2005-09-01

Last updated by the study team

2009-06-19

Who can join

Age: 20 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

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

Where it is running

• Kaiser Permanente Oakland — Oakland, California, United States
• Kaiser Permanente Division of Research — Oakland, California, United States
• Kaiser Permanente San Francisco — San Francisco, California, United States
• Kaiser Permanente Santa Clara/Santa Teresa — Santa Clara, California, United States
• Kaiser Permanente Walnut Creek — Walnut Creek, California, United States

Full record on ClinicalTrials.gov

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