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

NCT00460018 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2009-06-19

No results posted yet for this study

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.

Conditions

  • Gestational Diabetes Mellitus

Interventions

BEHAVIORAL

Diet, Exercise, and Breastfeeding 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)

Sponsors & Collaborators

  • Kaiser Permanente

    lead OTHER

Principal Investigators

  • Assiamira Ferrara, MD, PhD · Kaiser Permanente Division of Research

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00460018 on ClinicalTrials.gov