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Promoting Postpartum Weight Loss in Overweight Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00212251
First Posted: September 21, 2005
Last Update Posted: July 15, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Duke University
  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
Intervention Model: Parallel Assignment
Masking: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00212251


Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Truls Ostbye, MD, PhD, MPH Duke University
  More Information

Publications:
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 ( U.S. NIH Grant/Contract )
DK64986
Duke IRB #4399
First Submitted: September 19, 2005
First Posted: September 21, 2005
Last Update Posted: July 15, 2014
Last Verified: January 2010

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

Additional relevant MeSH terms:
Overweight
Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes