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Promoting Postpartum Weight Loss in Overweight Women
This study has been completed.
First Received: September 19, 2005   Last Updated: June 1, 2007   History of Changes
Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00212251
  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
Behavioral: motivational interviewing counseling

MedlinePlus related topics: Diets Exercise and Physical Fitness Obesity Postpartum Care Weight Control
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Promoting Postpartum Weight Loss in Overweight Women

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

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
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
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
Investigators
Principal Investigator: Truls Ostbye, MD, PhD, MPH Duke University
  More Information

No publications provided

Study ID Numbers: DK64986, DK64986, Duke IRB #4399
Study First Received: September 19, 2005
Last Updated: June 1, 2007
ClinicalTrials.gov Identifier: NCT00212251     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
obesity
postpartum period
exercise
diet
motivation

Study placed in the following topic categories:
Body Weight
Signs and Symptoms
Obesity
Weight Loss
Body Weight Changes
Nutrition Disorders
Overnutrition
Overweight

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

ClinicalTrials.gov processed this record on May 07, 2009