Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00212251
Status:
COMPLETED
Last Update Posted:
2014-07-15
First Post:
2005-09-19
Brief Title:
Promoting Postpartum Weight Loss in Overweight Women
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Promoting Postpartum Weight Loss in Overweight Women
Status:
COMPLETED
Status Verified Date:
2010-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor increase natural weight loss in postpartum Whether the postpartum period is a teachable moment for weight loss interventions can be investigated empirically
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DK064986 | NIH | None | None |
| DK64986 | None | None | None |
| Duke IRB 4399 | US NIH GrantContract | None | httpsreporternihgovquickSearchR01DK064986 |