Promoting Postpartum Weight Loss in Overweight Women
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Promoting Postpartum Weight Loss in Overweight Women |
- 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
- 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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| Principal Investigator: | Truls Ostbye, MD, PhD, MPH | Duke University |
More Information
Publications:
Additional 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 (DK64986), R01DK064986, DK64986, Duke IRB #4399 |
| Study First Received: | September 19, 2005 |
| Last Updated: | January 15, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Duke University:
|
obesity postpartum period exercise diet motivation |
Additional relevant MeSH terms:
|
Obesity Weight Loss Overweight Overnutrition |
Nutrition Disorders Body Weight Signs and Symptoms Body Weight Changes |
ClinicalTrials.gov processed this record on May 21, 2013