Promoting Postpartum Weight Loss in Overweight Women
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
moderate exercise and healthy, low-fat diet
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring obesity, postpartum period, exercise, diet, motivation
Eligibility 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
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lifestyle counseling
Arm Description
10 ActiveMoms classes, 8 Moms Time Out nutrition classes, 6 coaching calls, supportive materials
Outcomes
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
Full Information
NCT ID
NCT00212251
First Posted
September 19, 2005
Last Updated
July 14, 2014
Sponsor
Duke University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT00212251
Brief Title
Promoting Postpartum Weight Loss in Overweight Women
Official Title
Promoting Postpartum Weight Loss in Overweight Women
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2008 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, postpartum period, exercise, diet, motivation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (false)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle counseling
Arm Type
Experimental
Arm Description
10 ActiveMoms classes, 8 Moms Time Out nutrition classes, 6 coaching calls, supportive materials
Intervention Type
Behavioral
Intervention Name(s)
moderate exercise and healthy, low-fat diet
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Truls Ostbye, MD, PhD, MPH
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19049350
Citation
Ostbye T, Krause KM, Brouwer RJ, Lovelady CA, Morey MC, Bastian LA, Peterson BL, Swamy GK, Chowdhary J, McBride CM. Active Mothers Postpartum (AMP): rationale, design, and baseline characteristics. J Womens Health (Larchmt). 2008 Dec;17(10):1567-75. doi: 10.1089/jwh.2007.0674.
Results Reference
background
PubMed Identifier
19595557
Citation
Ostbye T, Krause KM, Lovelady CA, Morey MC, Bastian LA, Peterson BL, Swamy GK, Brouwer RJ, McBride CM. Active Mothers Postpartum: a randomized controlled weight-loss intervention trial. Am J Prev Med. 2009 Sep;37(3):173-80. doi: 10.1016/j.amepre.2009.05.016.
Results Reference
result
PubMed Identifier
21885890
Citation
Durham HA, Morey MC, Lovelady CA, Namenek Brouwer RJ, Krause KM, Ostbye T. Postpartum physical activity in overweight and obese women. J Phys Act Health. 2011 Sep;8(7):988-93. doi: 10.1123/jpah.8.7.988.
Results Reference
derived
PubMed Identifier
21185967
Citation
Durham HA, Lovelady CA, Brouwer RJ, Krause KM, Ostbye T. Comparison of dietary intake of overweight postpartum mothers practicing breastfeeding or formula feeding. J Am Diet Assoc. 2011 Jan;111(1):67-74. doi: 10.1016/j.jada.2010.10.001.
Results Reference
derived
PubMed Identifier
20821042
Citation
Krause KM, Lovelady CA, Ostbye T. Predictors of breastfeeding in overweight and obese women: data from Active Mothers Postpartum (AMP). Matern Child Health J. 2011 Apr;15(3):367-75. doi: 10.1007/s10995-010-0667-7.
Results Reference
derived
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Promoting Postpartum Weight Loss in Overweight Women
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