FirstWIND: Weight Loss Interventions After Delivery - Full Text View

Sponsor:	Johns Hopkins University
Collaborator:	American Diabetes Association
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00377026

Purpose

This a pilot intervention study in which postpartum women will be randomized to receive a 6-month postpartum weight loss intervention or usual care.

Condition	Intervention
Overweight Obesity	Behavioral: lifestyle intervention

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	FirstWIND: Weight Loss Interventions After Delivery

Resource links provided by NLM:

MedlinePlus related topics: Obesity Postpartum Care Weight Control

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

weight loss [ Time Frame: baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

health status [ Time Frame: baseline and six months ] [ Designated as safety issue: No ]
body mass index [ Time Frame: baseline, 3 months, 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	September 2006
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: lifestyle participants receive lifestyle intervention	Behavioral: lifestyle intervention Lifestyle modification including individual sessions with an interventionist to discuss dietary intake and exercise. Group sessions with other participants randomized to the lifestyle intervention to discuss lifestyle modification and group exercise.

Detailed Description:

Overweight and obesity affect over 15 million adult women in the United States. Postpartum weight retention has been shown to be one factor contributing to weight retention, obesity and possible development of type 2 diabetes. African-American women and other minority women are at especially high risk for the development of obesity and type 2 diabetes. We propose to pilot a six-month postpartum-specific lifestyle intervention among urban-based, postpartum African-American women.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Postpartum women with a pre-pregnancy or first trimester body mass index of 28 or greater or a history of gestational diabetes in the most recent pregnancy.

Exclusion Criteria:

Current cardiac disease or serious chronic disease, including cancer.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00377026

Locations

United States, Maryland
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21287

Sponsors and Collaborators

Johns Hopkins University

American Diabetes Association

Investigators

Principal Investigator:

Wanda Nicholson, MD, MPH

Johns Hopkins School of Medicine

More Information

No publications provided

Responsible Party:	Wanda Nicholson, MD, MPH, Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00377026 History of Changes
Other Study ID Numbers:	M051633
Study First Received:	September 13, 2006
Last Updated:	June 18, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by Johns Hopkins University:

weight loss
postpartum
weight retention

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 February 13, 2012