Fresh Start: A Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- University of Massachusetts, Worcester
- Enrollment
- 139
- Locations
- 1
- Primary Endpoint
- Change in Body Mass Index from baseline
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The Fresh Start postpartum weight loss program will test the effectiveness of a group-based weight loss intervention that includes videos featuring peers who have successfully achieved postpartum weight loss. The group-based condition will be compared to a control condition involving print materials related to weight loss.
Detailed Description
The goal is to study the effectiveness and implementation of a postpartum weight loss intervention for WIC clients that has potential for sustainability. The investigators will compare outcomes among participants in a group-based weight loss intervention condition (Fresh Start) to outcomes among participants in a self-directed, print materials only, comparison group. The Fresh Start intervention, informed by formative research studies, consists of an 8-session group-based weight loss intervention delivered by WIC nutritionists and peer leaders. The intervention integrates key educational and skill building strategies from the lifestyle arm of the Diabetes Prevention Program with delivery strategies and messages specific for the WIC program and postpartum women. The intervention will be evaluated in a randomized clinical trial that will contribute to generalizable knowledge.
Investigators
Stephenie Lemon
Principal Investigator
University of Massachusetts, Worcester
Eligibility Criteria
Inclusion Criteria
- •6 months or less postpartum
- •Speaks English
- •BMI 25 or greater
- •Client of WIC program, Worcester MA
Exclusion Criteria
- •Not able to give informed consent
Outcomes
Primary Outcomes
Change in Body Mass Index from baseline
Time Frame: 3 months, 12 months
Secondary Outcomes
- Change in Pregnancy Physical Activity Questionnaire score from baseline(3 months, 12 months)
- Change in 24-hour dietary recall from baseline(3 months, 12 months)