Condition(s) treated: Pre-Pregancy Overweight; Pre-Pregnancy Obesity

Intervention: lifestyle modification including nutrition and exercise (Behavior)

Enrollment status: Recruiting. Expecting to enroll 50 people.

Sponsor: Johns Hopkins University

Principal investigator(s) or official(s):
Wanda Nicholson, MD, MPH, Principal Investigator, Affiliation: Johns Hopkins School of Medicine

Overall contact:
Wanda Nicholson, MD, MPH, Phone: 443-287-6942, Email: wnichol@jhmi.edu

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

Official title: FirstWIND: Weight Loss Interventions After Delivery

Study design: Interventional, Prevention, Randomized, Open Label, Placebo Control, Single Group Assignment, Efficacy Study

Primary outcome: weight loss

Secondary outcome: health status; body mass index

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.

Minimum eligible age: 18 Years. Eligible gender(s): Female.

Criteria:

Inclusion Criteria:

- Postpartum women with a pre-pregnancy or first trimester body mass index of 28 or greater of a history of gestational diabetes in the most recent pregnancy.

Exclusion Criteria:

- Current cardiac disease or serious chronic disease, including cancer

Wanda Nicholson, MD, MPH, Phone: 443-287-6942, Email: wnichol@jhmi.edu

Johns Hopkins School of Medicine, Baltimore, Maryland 21287, United States; Recruiting
Wanda Nicholson, MD, MPH, Phone: 443-287-6942

Start date: September 2006
End date: May 2008
Last updated: September 13, 2006