Promoting Postpartum Weight Loss in Overweight Women

Study Overview
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Brief Summary
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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
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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.

Official Title
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Promoting Postpartum Weight Loss in Overweight Women

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: moderate exercise and healthy, low-fat diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle counseling<br>10 ActiveMoms classes, 8 Moms Time Out nutrition classes, 6 coaching calls, supportive materials | Behavioral: moderate exercise and healthy, low-fat diet<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, postpartum period, exercise, diet, motivation