FirstWIND: Weight Loss Interventions After Delivery

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00377026
• Collaborator: American Diabetes Association (Other)
• Enrollment: 50
• Location: 1
• Arm: 1
• Duration (Months): 18
• Patients Per Site Per Month: 2.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight; Obesity	Behavioral: lifestyle intervention	N/A

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 Design

• Study Type: Interventional
• Anticipated 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: Sep 1, 2006
• Actual Primary Completion Date: Mar 1, 2008
• Actual Study Completion Date: Mar 1, 2008

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. weight loss [baseline, 3 months, and 6 months]

Secondary Outcome Measures

1. health status [baseline and six months]

2. body mass index [baseline, 3 months, 6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins School of Medicine	Baltimore	Maryland	United States	21287

Sponsors and Collaborators

• Johns Hopkins University
• American Diabetes Association

Investigators

• Principal Investigator: Wanda Nicholson, MD, MPH, Johns Hopkins School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00377026
• Other Study ID Numbers: M051633
• First Posted: Sep 15, 2006
• Last Update Posted: Jun 19, 2009
• Last Verified: Jun 1, 2009

• Keywords provided by , ,: weight loss; postpartum; weight retention
• Additional relevant MeSH terms: Overweight; Weight Loss

Study Results

No Results Posted as of Jun 19, 2009