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OpenTrials
Completed

NCT Number: NCT00377026

FirstWIND: Weight Loss Interventions After Delivery

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

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Key information

Conditions

Overweight Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins School of Medicine

Baltimore, Maryland, 21287, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lifestyle Intervention

Behavioral

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 outcomes

  1. weight loss

    Time frame: baseline, 3 months, and 6 months

Secondary outcomes

  1. health status

    Time frame: baseline and six months

  2. body mass index

    Time frame: baseline, 3 months, 6 months

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • American Diabetes Association

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Sep 15, 2006
Registry last updated
Jun 19, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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