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Promoting Postpartum Weight Loss in Overweight Women

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00212251
First received: September 19, 2005
Last updated: July 14, 2014
Last verified: January 2010
  Purpose

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.


Condition Intervention
Obesity
Behavioral: moderate exercise and healthy, low-fat diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Promoting Postpartum Weight Loss in Overweight Women

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 450
Study Start Date: August 2004
Estimated Study Completion Date: April 2008
Arms Assigned Interventions
Experimental: Lifestyle counseling
10 ActiveMoms classes, 8 Moms Time Out nutrition classes, 6 coaching calls, supportive materials
Behavioral: moderate exercise and healthy, low-fat diet

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00212251

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Truls Ostbye, MD, PhD, MPH Duke University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00212251     History of Changes
Other Study ID Numbers: Pro00012546, R01DK064986, DK64986, Duke IRB #4399
Study First Received: September 19, 2005
Last Updated: July 14, 2014
Health Authority: United States: Federal Government

Keywords provided by Duke University:
obesity
postpartum period
exercise
diet
motivation

Additional relevant MeSH terms:
Obesity
Overweight
Weight Loss
Body Weight
Body Weight Changes
Nutrition Disorders
Overnutrition
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014