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Promoting Postpartum Weight Loss in Overweight Women

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.
 
ClinicalTrials.gov Identifier: NCT00212251
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : July 15, 2014
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE September 19, 2005
First Posted Date  ICMJE September 21, 2005
Last Update Posted Date July 15, 2014
Study Start Date  ICMJE August 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2005)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2005)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Promoting Postpartum Weight Loss in Overweight Women
Official Title  ICMJE Promoting Postpartum Weight Loss in Overweight Women
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Obesity
Intervention  ICMJE Behavioral: moderate exercise and healthy, low-fat diet
Study Arms  ICMJE Experimental: Lifestyle counseling
10 ActiveMoms classes, 8 Moms Time Out nutrition classes, 6 coaching calls, supportive materials
Intervention: Behavioral: moderate exercise and healthy, low-fat diet
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 2, 2006)
450
Original Enrollment  ICMJE
 (submitted: September 19, 2005)
400
Study Completion Date  ICMJE April 2008
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00212251
Other Study ID Numbers  ICMJE Pro00012546
R01DK064986 ( U.S. NIH Grant/Contract )
DK64986
Duke IRB #4399
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: Truls Ostbye, MD, PhD, MPH Duke University
PRS Account Duke University
Verification Date January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP