Home
Search
Study Topics
Glossary
|
|
|
|
|
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 |
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 |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Promoting Postpartum Weight Loss in Overweight Women |
Estimated Enrollment: | 450 |
Study Start Date: | August 2004 |
Estimated Study Completion Date: | April 2008 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 |
Principal Investigator: | Truls Ostbye, MD, PhD, MPH | Duke University |
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 |
obesity postpartum period exercise diet motivation |
Body Weight Signs and Symptoms Obesity Weight Loss |
Body Weight Changes Nutrition Disorders Overnutrition Overweight |
Body Weight Signs and Symptoms Obesity Weight Loss |
Body Weight Changes Nutrition Disorders Overweight Overnutrition |