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

This study has been completed.
Sponsor:
Information provided by:
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00460018
First received: April 11, 2007
Last updated: June 18, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention Phase
Gestational Diabetes Mellitus
Behavioral: Diet, Exercise, and Breastfeeding Intervention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Diet, Exercise and Breastfeeding Intervention (DEBI) Program for Women With Gestational Diabetes

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • Postpartum weight retention [ Time Frame: no more than 1.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • reduced plasma glucose levels (measured at 6 weeks and 1 year postpartum) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • levels of plasma insulin [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • markers of insulin resistance [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • adiponectin [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • dietary fat [ Time Frame: no more than 1.5 years ] [ Designated as safety issue: No ]
  • physical activity [ Time Frame: no more than 1.5 years ] [ Designated as safety issue: No ]
  • breastfeeding duration [ Time Frame: no more than 1.5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: September 2005
Arms Assigned Interventions
Experimental: Intervention
Women receiving the DEBI Intervention
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)

Other Name: Intervention
No Intervention: No intervention
Women receiving standard care

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

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00460018

Locations
United States, California
Kaiser Permanente Division of Research
Oakland, California, United States, 94612
Kaiser Permanente Oakland
Oakland, California, United States, 94611
Kaiser Permanente San Francisco
San Francisco, California, United States, 94115
Kaiser Permanente Santa Clara/Santa Teresa
Santa Clara, California, United States, 95051
Kaiser Permanente Walnut Creek
Walnut Creek, California, United States, 94596
Sponsors and Collaborators
Kaiser Permanente
Investigators
Principal Investigator: Assiamira Ferrara, MD, PhD Kaiser Permanente Division of Research
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assiamira Ferrara, MD PhD, Kaiser Permanente Division of Research
ClinicalTrials.gov Identifier: NCT00460018     History of Changes
Other Study ID Numbers: CN-04AFerr-04-H, CN-03AFerr-02
Study First Received: April 11, 2007
Last Updated: June 18, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Kaiser Permanente:
Gestational Diabetes Mellitus
Weight Loss
Physical Activity
Breastfeeding
Pregnancy
Postpartum
Intervention
Prevention

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications

ClinicalTrials.gov processed this record on July 10, 2014