Prevention of Diabetes Using Mobile-enabled, Virtual Delivery of the National Diabetes Prevention (DPP) Program: a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Noom Inc.
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- Change in weight
研究概览
简要总结
This study will test the weight loss efficacy of a mobile diabetes prevention program intervention. Half of the sample of prediabetic adults will receive the virtual DPP and half will receive usual medical care.
详细描述
There were 84.1 million people with pre-diabetes, 30.3 million people with diagnosed and 7.2 million with undiagnosed diabetes in the United States in 2015, and nearly 2 million are diagnosed with it every year. By 2050, the CDC estimates that 1 in every 3 people globally will have diabetes, a leading cause of death and disability.
The primary goal of this study is to evaluate the efficacy of the Noom Coach Diabetes Prevention Program mobile platform versus usual medical care. The best intervention to date for prediabetes is the Centers for Disease Control and Prevention's Diabetes Prevention Program, yet there is limited research investigating a mobile-based delivery of the DPP. Pre-diabetes is often discovered during routine medical visitation/annual screening (usual care), but face-to-face time with clinicians is often limited. Exploring novel ways, such as mHealth interventions to empower patients to pursue lifestyle change and prevent or delay diabetes onset is critical to addressing the growing diabetes epidemic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
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
- •English-speaking
- •18 years of age and older
- •Referral from the patient's physician
- •Hemoglobin A1C: 5.7 - 6.4 within the 3 months prior to enrollment
- •Own a smartphone (Apple or Android)
排除标准
- •Recent weight loss (by patient report, >5 lbs in the 6 months preceding enrollment visit)
- •previous diagnosis of type 1 or type 2 diabetes
- •serious or persistent mental illnesses
- •more than 72 hours of hospitalization in the last 30 days
- •Enrollment in a structured weight-loss program currently or within the 1 month preceding study enrollment
- •Currently nursing
- •Have given birth within the past 3 months
- •Has been discouraged by a physician to enroll in a DPP program
研究组 & 干预措施
Noom Coach DPP
Individuals will receive special instructions on how to use the app and will self-monitor their weight, exercise and receive daily DPP core content through the app over 16 weeks plus guidance from a coach, and will thereafter receive post-core DPP content up to 52 weeks.
干预措施: Noom Coach DPP (Behavioral)
Usual Care
The control group will be a "usual care" condition in which participants are free to seek any assistance for their medical care during the study period plus a paper version of the DPP curriculum.
结局指标
主要结局
Change in weight
时间窗: Baseline, 6, and 12 months
Body weight recorded during follow-up appointments at the medical clinic.
次要结局
- Change in hemoglobin A1c(Baseline, 6, and 12 months)