Weight Loss and Maintenance for Rural, African American Communities of Faith (The WORD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 425
- 试验地点
- 2
- 主要终点
- Change in weight from 6 months to 18 months
研究概览
简要总结
The WORD (Wholeness, Oneness, Righteousness, Deliverance) is a faith-based weight loss study in rural, African American adults of faith. The study will see whether a weight loss + maintenance intervention will cause participants to maintain their weight better than a weight loss only intervention.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •African American
- •Aged 18 and older
- •Have a BMI ) > 25 kg/m²
- •Associated with a participating church through membership or participation in a church activity
- •Free of medical problems that might contraindicated participation in a behavioral weight reduction program containing an exercise component
- •Individuals taking sulfonylureas who have a letter from their doctor supporting their participation in the study will be considered eligible
- •Exclusion Criteria
- •Not had a heart attack or stroke in the past 6 months
- •Not currently on medication that might affect weight loss or require medical monitoring (i.e. insulin)
- •Not pregnant, not pregnant in the previous six months, or lactating
- •Not enrolled in another weight reduction program
- •Agree to complete the program assigned to them
- •Never had weight loss surgery
- •Not have lost more than 10% body weight in the previous 6 months
- •Not have a clinically significant medical condition likely to impact weight or any condition that makes it unlikely the participant would be available to follow the protocol for 18 months
排除标准
- 未提供
研究组 & 干预措施
Weight loss core
Participants will receive a culturally adapted version of the Diabetes Prevention Program core (16 session) program.
干预措施: Weight loss core (Behavioral)
Weight loss core plus maintenance
Participants will receive a culturally adapted version of the Diabetes Prevention Program core (16 session) program PLUS 12 maintenance sessions.
干预措施: Weight loss core (Behavioral)
Weight loss core plus maintenance
Participants will receive a culturally adapted version of the Diabetes Prevention Program core (16 session) program PLUS 12 maintenance sessions.
干预措施: Weight loss core plus maintenance (Behavioral)
结局指标
主要结局
Change in weight from 6 months to 18 months
时间窗: Change from 6 months to 18 months
次要结局
未报告次要终点