FirstWIND: Weight Loss Interventions After Delivery - Tabular View

Tracking Information

First Received Date ^ICMJE

September 13, 2006

Last Updated Date

June 18, 2009

Start Date ^ICMJE

September 2006

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

weight loss

Change History

Complete list of historical versions of study NCT00377026 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

health status
body mass index

Descriptive Information

Brief Title ^ICMJE

FirstWIND: Weight Loss Interventions After Delivery

Official Title ^ICMJE

FirstWIND: Weight Loss Interventions After Delivery

Brief Summary

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

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Overweight
Obesity

Intervention ^ICMJE

Behavioral: lifestyle intervention

Study Arms / Comparison Groups

Experimental: participants receive lifestyle intervention

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

March 2008

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00377026

Responsible Party

Wanda Nicholson, MD, MPH, Johns Hopkins University

Study ID Numbers ^ICMJE

M051633

Study Sponsor ^ICMJE

Johns Hopkins University

Collaborators ^ICMJE

American Diabetes Association

Investigators ^ICMJE

Principal Investigator:

Wanda Nicholson, MD, MPH

Johns Hopkins School of Medicine

Information Provided By

Johns Hopkins University

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP