FirstWIND: Weight Loss Interventions After Delivery - Full Text View

Sponsors and Collaborators:	Johns Hopkins University 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

MedlinePlus related topics: Obesity Weight Control

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	FirstWIND: Weight Loss Interventions After Delivery

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
Estimated Study Completion Date:	March 2008
Estimated Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
lifestyle: Experimental 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 of 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

Contacts

Contact: Wanda Nicholson, MD, MPH	443-287-6942	wnichol@jhmi.edu
Contact: Payal Ghosh, BA	443-287-6942	pghosh@jhmi.edu

Locations

United States, Maryland
Johns Hopkins School of Medicine	Recruiting
Baltimore, Maryland, United States, 21287
Contact: Wanda Nicholson, MD, MPH 443-287-6942

Sponsors and Collaborators

Johns Hopkins University

American Diabetes Association

Investigators

Principal Investigator:

Wanda Nicholson, MD, MPH

Johns Hopkins School of Medicine

More Information

Responsible Party:	Johns Hopkins University ( Wanda Nicholson, MD, MPH )
Study ID Numbers:	M051633
Study First Received:	September 13, 2006
Last Updated:	December 26, 2007
ClinicalTrials.gov Identifier:	NCT00377026
Health Authority:	United States: Institutional Review Board

Keywords provided by Johns Hopkins University:

weight loss
postpartum
weight retention

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Weight Loss
Body Weight Changes

Nutrition Disorders
Overnutrition
Overweight
Urinary Retention

ClinicalTrials.gov processed this record on January 15, 2009