Fresh Start: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 139
- 试验地点
- 2
- 主要终点
- Change in Body Mass Index from baseline
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •6 months or less postpartum
- •Speaks English
- •BMI 25 or greater
- •Client of WIC program, Worcester MA
排除标准
- •Not able to give informed consent
研究组 & 干预措施
Group program
8-session group weight loss program and 4 follow-up phone counseling sessions
干预措施: Group program (Behavioral)
Print Materials
8 weekly mailings of print materials covering weight loss topics through US mail.
干预措施: Print Materials (Behavioral)
结局指标
主要结局
Change in Body Mass Index from baseline
时间窗: 3 months, 12 months
次要结局
- 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)
研究者
Stephenie Lemon
Principal Investigator
University of Massachusetts, Worcester