Promoting Postpartum Weight Loss in Overweight Women

Duke University

Status: Completed

Conditions: Obesity

Treatments: Behavioral: moderate exercise and healthy, low-fat diet

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00212251

R01DK064986 (U.S. NIH Grant/Contract)

Duke IRB #4399

Pro00012546

DK64986

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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450 participants in 1 patient group

Lifestyle counseling

Experimental group

Description:

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

Treatment:

Behavioral: moderate exercise and healthy, low-fat diet