Science-based Habit Formation App As an Adjunct to the National Diabetes Prevention Program (DPP) Lifestyle Change Program (LCP) to Increase Engagement, Participation and Outcomes of Underserved Populations and Others Eligible for the DPP LCP
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Engagement
研究概览
简要总结
The goal of this clinical trial is to learn whether a companion software application can improve program engagement in the National Diabetes Prevention Program in adults with prediabetes. The main question[s] it aims to answer [is/are]:
Do participants using the software application (the intervention group) have better engagement with the Diabetes Prevention Program than those who do not use the companion software application (the control group)? Are participants using the software application (the intervention group) more likely to stay in the Diabetes Prevention Program longer than those who do not use the companion software application (the control group)?
Participants are those who have signed up for their local Diabetes Prevention Program and agree to be in the study.
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
- 否
入选标准
- •is eligible for and enrolls in a live or distance LCP at a designated study site during the enrollment period of the study
- •has a smartphone or other device able to engage with the FT LCP app
- •can read basic 5th grade English, as used in the FT LCP app
排除标准
- •Cohorts and sites enrolled in concurrent, similar health app-based studies
结局指标
主要结局
Engagement
时间窗: From enrollment to end of the Lifestyle Change Program, up to 12 months.
The primary measure for participant engagement will be the number of classes attended by a participant.
Efficacy
时间窗: From enrollment to end of the Lifestyle Change Program, up to 12 months.
The primary measure of efficacy will be the percentage of participants who reach the LCP goal of ≥5% weight loss by the end of the study period.
Retention
时间窗: From enrollment to end of the Lifestyle Change Program, up to 12 months.
The primary measure for retention will be the percentage of participants that remain enrolled in the LCP at the end of the study period.
次要结局
未报告次要终点