FirstWIND: Weight Loss Interventions After Delivery

NCT ID: NCT00377026

Last Updated: 2009-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-03-31

Brief Summary

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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

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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.

Conditions

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Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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lifestyle

participants receive lifestyle intervention

Group Type EXPERIMENTAL

lifestyle intervention

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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American Diabetes Association

OTHER

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Johns Hopkins University

Principal Investigators

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Wanda Nicholson, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Medicine

Locations

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Johns Hopkins School of Medicine

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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M051633

Identifier Type: -

Identifier Source: org_study_id

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