Diet, Exercise, and Breastfeeding Intervention Program for Women With Gestational Diabetes (DEBI Trial)
Condition: Gestational Diabetes Mellitus
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Diet, Exercise, and Breastfeeding Intervention
Intervention type(s): Behavioral
Intervention description(s): 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 intervention name(s): Intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Gestational Diabetes Mellitus; Weight Loss; Physical Activity; Breastfeeding; Pregnancy; Postpartum; Intervention; Prevention