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Sponsored by: |
Kaiser Permanente |
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Information provided by: | Kaiser Permanente |
ClinicalTrials.gov Identifier: | NCT00460018 |
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 II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Diet, Exercise and Breastfeeding Intervention (DEBI) Program for Women With Gestational Diabetes |
Estimated Enrollment: | 180 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | October 2008 |
Arms | Assigned Interventions |
---|---|
Intervention: Experimental
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) |
No intervention: No Intervention
Women receiving standard care
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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.
Ages Eligible for Study: | 20 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Monique M Hedderson, PhD | 510-891-3580 | monique.m.hedderson@kp.org |
Contact: Samantha F Ehrlich, MPH | 510-891-3505 | samantha.ehrlich@kp.org |
United States, California | |
Kaiser Permanente Division of Research | Recruiting |
Oakland, California, United States, 94612 | |
Principal Investigator: Assiamira Ferrara, MD, PhD | |
Kaiser Permanente Santa Clara/Santa Teresa | Recruiting |
Santa Clara, California, United States, 95051 | |
Contact: Yvonne Crites, MD 408-851-3570 Yvonne.Crites@kp.org | |
Sub-Investigator: Yvonne Crites, MD | |
Kaiser Permanente San Francisco | Recruiting |
San Francisco, California, United States, 94115 | |
Contact: Anne Regenstein, MD 415-833-2493 Anne.Regenstein@ncal.kaiperm.org | |
Sub-Investigator: Anne Regenstein, MD | |
Kaiser Permanente Oakland | Recruiting |
Oakland, California, United States, 94611 | |
Contact: Lawrence Newman, MD 510-752-7462 Larry.Newman@kp.org | |
Sub-Investigator: Lawrence Newman, MD | |
Kaiser Permanente Walnut Creek | Recruiting |
Walnut Creek, California, United States, 94596 | |
Contact: Jeffrey Maier, MD 925-295-4513 Jeffrey.Maier@ncal.kaiperm.org | |
Sub-Investigator: Jeffrey Maier, MD |
Principal Investigator: | Assiamira Ferrara, MD, PhD | Kaiser Permanente Division of Research |
Responsible Party: | Kaiser Permanente Division of Research ( Assiamira Ferrara, MD PhD ) |
Study ID Numbers: | CN-04AFerr-04-H, CN-03AFerr-02 |
Study First Received: | April 11, 2007 |
Last Updated: | September 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00460018 |
Health Authority: | United States: Institutional Review Board |
Gestational Diabetes Mellitus Weight Loss Physical Activity Breastfeeding |
Pregnancy Postpartum Intervention Prevention |
Body Weight Pregnancy Complications Metabolic Diseases Weight Loss Diabetes Mellitus |
Endocrine System Diseases Diabetes, Gestational Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |