Enhancing the Diabetes Prevention Program to Promote Weight Loss Among Nonresponders in a Community-Based Lifestyle Intervention.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 403
- 试验地点
- 21
- 主要终点
- Change in Weight at 6 Months
研究概览
简要总结
This study seeks to establish the efficacy of identifying weight loss nonresponders early in a Diabetes Prevention Program (DPP) intervention in 20 community settings (primarily churches and community centers) and providing them with individual-level, enhanced treatment through telephone contacts and access to additional resources. Additionally, potential mediators and moderators of the relationship between intervention status and weight loss response at 6 months in both nonresponders and responders will be examined and a cost-effectiveness analysis to evaluate the cost of the intervention will be conducted.
This study addresses key gaps in the literature about the weight loss effects of identifying nonresponders early and characterizing individuals who need more intense personalized strategies. The investigators hypothesize that changes between baseline and 3 months will be more pronounced among the nonresponders in the intervention group compared to the nonresponders in the active control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •self-described as Black
- •non-diabetic
- •body mass index (BMI) equal to or greater than 25
- •CDC diabetes risk assessment greater than or equal to 5 or diabetes pre-diagnosis or history of gestational diabetes
- •live within driving distance of participating church/site
排除标准
- •diagnosed Type 1 or 2 diabetes
- •pregnant or planning to become pregnant during study period
- •contraindications to moderate physical activity
- •serious medical condition that contradicts weight loss
- •not Black or African American
研究组 & 干预措施
DPP-GLB Standard
Participants in this group will receive the standard Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.
干预措施: DPP-GLB Standard (Behavioral)
DPP-GLB Enhanced
Participants in this group will receive the enhanced Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.
干预措施: DPP-GLB Enhanced (Behavioral)
结局指标
主要结局
Change in Weight at 6 Months
时间窗: 6 months (at baseline and 6 months)
Weight will be measured in pounds using a cellular scale at baseline and at 6 months.
Change in Weight at 12 Weeks
时间窗: 12 weeks (at baseline and12 weeks)
Weight will be measured in pounds using a cellular scale at baseline and at 12 weeks.
次要结局
- Change in Blood Pressure at 6 Months(6 months (at baseline and 6 months))
- Change in Blood Pressure at 12 Weeks(12 weeks (at baseline and 12 weeks))
- Impact of Weight on Quality of Life(6 months)
- Change in Physical Activity at 12 Weeks(12 weeks (at baseline and 12 weeks))
- Change in Physical Activity at 6 Months(6 months (at baseline and 6 months))
- Change in Dietary Intake at 12 Weeks(12 weeks (at baseline and 12 weeks))
- Change in Dietary Intake at 6 Months(6 months (at baseline, 12 weeks, 6 months))
- Cost Analysis(6 months)
研究者
Lovoria Williams
Associate Professor
University of Kentucky