Skip to content

Promoting Postpartum Weight Loss in Overweight Women

Promoting Postpartum Weight Loss in Overweight Women

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00212251
Enrollment
450
Registered
2005-09-21
Start date
2004-08-31
Completion date
2008-04-30
Last updated
2014-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

obesity, postpartum period, exercise, diet, motivation

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.

Interventions

BEHAVIORALmoderate exercise and healthy, low-fat diet

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026