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FirstWIND: Weight Loss Interventions After Delivery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00377026
Recruitment Status : Completed
First Posted : September 15, 2006
Last Update Posted : June 19, 2009
American Diabetes Association
Information provided by:
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Overweight Obesity Behavioral: lifestyle intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: FirstWIND: Weight Loss Interventions After Delivery
Study Start Date : September 2006
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. weight loss [ Time Frame: baseline, 3 months, and 6 months ]

Secondary Outcome Measures :
  1. health status [ Time Frame: baseline and six months ]
  2. body mass index [ Time Frame: baseline, 3 months, 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00377026

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United States, Maryland
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
American Diabetes Association
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Principal Investigator: Wanda Nicholson, MD, MPH Johns Hopkins School of Medicine
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Responsible Party: Wanda Nicholson, MD, MPH, Johns Hopkins University Identifier: NCT00377026    
Other Study ID Numbers: M051633
First Posted: September 15, 2006    Key Record Dates
Last Update Posted: June 19, 2009
Last Verified: June 2009
Keywords provided by Johns Hopkins University:
weight loss
weight retention
Additional relevant MeSH terms:
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Weight Loss
Body Weight
Body Weight Changes