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FirstWIND: Weight Loss Interventions After Delivery

Primary Purpose

Overweight, Obesity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

lifestyle intervention

About this trial

This is an interventional prevention trial for Overweight focused on measuring weight loss, postpartum, weight retention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Johns Hopkins School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

lifestyle

Arm Description

participants receive lifestyle intervention

Outcomes

Primary Outcome Measures

weight loss

Secondary Outcome Measures

health status

body mass index

Full Information

NCT ID

NCT00377026

First Posted

September 13, 2006

Last Updated

June 18, 2009

Sponsor

Johns Hopkins University

Collaborators

American Diabetes Association

1. Study Identification

Unique Protocol Identification Number

NCT00377026

Brief Title

FirstWIND: Weight Loss Interventions After Delivery

Official Title

FirstWIND: Weight Loss Interventions After Delivery

Study Type

Interventional

2. Study Status

Record Verification Date

June 2009

Overall Recruitment Status

Completed

Study Start Date

September 2006 (undefined)

Primary Completion Date

March 2008 (Actual)

Study Completion Date

March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Johns Hopkins University

Collaborators

American Diabetes Association

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight, Obesity

Keywords

weight loss, postpartum, weight retention

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

lifestyle

Arm Type

Experimental

Arm Description

participants receive lifestyle intervention

Intervention Type

Behavioral

Intervention Name(s)

lifestyle intervention

Intervention Description

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 Measure Information:

Title

weight loss

Time Frame

baseline, 3 months, and 6 months

Secondary Outcome Measure Information:

Title

health status

Time Frame

baseline and six months

Title

body mass index

Time Frame

baseline, 3 months, 6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wanda Nicholson, MD, MPH

Organizational Affiliation

Johns Hopkins School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Johns Hopkins School of Medicine

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

12. IPD Sharing Statement

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FirstWIND: Weight Loss Interventions After Delivery

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