Promoting Postpartum Weight Loss in Overweight Women

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: moderate exercise and healthy, low-fat diet

• Registration Number: NCT00212251
• Lead Sponsor: Duke University

Brief Summary

The purpose of this study is to evaluate, in a five-year randomized controlled trial, the efficacy of an intervention (AMP - ACTIVE MOTHERS POSTPARTUM) to increase physical activity and promote a healthy diet (decreased calorie and fat intake) for weight loss among postpartum women who were overweight or obese prior to pregnancy. The hypothesis is that the proportion of women losing at least 10% of BMI from baseline to 12 months post-intervention will be significantly greater in the AMP intervention arm than in the minimal care arm.

Detailed Description

Retention of weight gained in pregnancy contributes to the development of overweight and obesity in middle age, now at epidemic proportions in America. While interventions to reduce weight retention specifically targeting the postpartum period have been few, interventions that promote modest weight loss starting in early postpartum are safe and could be efficacious, particularly for women who were overweight prior to pregnancy. Moreover, postpartum-related changes in cognitive factors (risk perceptions), behavioral factors (physical activity, diet), self concept (self-esteem) and social role (work, food preparation, child care) may make this time a "teachable moment" that could be capitalized upon by formal interventions. Interventions could leverage natural weight changes to encourage adoption of a healthy diet and increase physical activity, which together could accelerate and/or increase natural weight loss in postpartum. Whether the postpartum period is a teachable moment for weight loss interventions can be investigated empirically.

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2005-09-19
• Study First Submitted QC: 2005-09-19
• Study First Posted: 2005-09-21
• Study Completion: 2008-04
• Status Verified: 2010-01
• Last Update Submitted: 2014-07-14
• Last Update Posted: 2014-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 450

Inclusion Criteria

• pre-pregnancy BMI>24
• over 18
• delivered baby in past 6 weeks
• English speaking
• driving distance to Duke University Medical Center

Exclusion Criteria

• Hemodynamically significant heart disease
• Restrictive lung disease
• Severe anemia
• Unevaluated maternal cardiac arrythmia
• Chronic bronchitis
• Poorly controlled Type 1 diabetes
• Poorly controlled hypertension
• Orthopedic limitations
• Poorly controlled seizure disorder
• Poorly controlled hyperthyroidism

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle counseling	moderate exercise and healthy, low-fat diet	10 ActiveMoms classes, 8 Moms Time Out nutrition classes, 6 coaching calls, supportive materials

Primary Outcome Measures

Name	Time	Method
BMI change from baseline to 12 months post-intervention (24 months postpartum) will be assessed via self-report and validated by in-person weight measurement. The proportion of women who lose 10% of baseline BMI

Secondary Outcome Measures

Name	Time	Method
Change in BMI from pre-pregnancy to 12 months post-intervention; proportion below their pre-pregnancy weight at 1, 6 and 12 months post-intervention; and BMI change from baseline to 1 a

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States