Promoting Postpartum Weight Loss in Overweight Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2008-04-30

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.

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Lifestyle counseling

10 ActiveMoms classes, 8 Moms Time Out nutrition classes, 6 coaching calls, supportive materials

Group Type EXPERIMENTAL

moderate exercise and healthy, low-fat diet

Intervention Type BEHAVIORAL

Interventions

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moderate exercise and healthy, low-fat diet

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes