Effectiveness of Digital Versus In-Person Diabetes Prevention Programs

数字与面对面糖尿病预防计划的有效性

• 批准号: 10034797
• 负责人: NESTORAS N MATHIOUDAKIS
• 金额: $ 73.31万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-15 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10034797
• 关键词: Address; Adherence; Adult; Affect; Age; American; Artificial Intelligence; Behavioral; Behavioral Sciences; Benchmarking; Blood Glucose; Body Weight decreased; Caloric Restriction; Cellular Phone; Centers for Disease Control and Prevention (U.S.); Chronic Disease; Clinical; Counseling; Data; Diabetes Mellitus; Diabetes prevention; Diet Monitoring; Effectiveness; Fatty acid glycerol esters; Favorable Clinical Outcome; Feasibility Studies; Feedback; Future; Generations; Glycosylated hemoglobin A; Goals; Health; Health Promotion; Health Technology; Health behavior change; Hour; Human; Human Resources; Hybrids; Intervention; Knowledge; Life Style; Maintenance; Measures; Mediating; Methods; Modality; Monitor; Motivation; Non-Insulin-Dependent Diabetes Mellitus; Obesity; Observational Study; Outcome; Outcome Measure; Overweight; Participant; Patients; Persons; Physical activity; Positioning Attribute; Prediabetes syndrome; Prevention; Questionnaires; Randomized; Randomized Controlled Trials; Research; Risk; Science; Technology; Testing; Time; Visit; Weight; Weight Gain; adult obesity; arm; base; blood glucose regulation; comparative effectiveness study; compare effectiveness; cost; cost effective; diabetes prevention program; digital; disorder prevention; follow-up; high risk; high risk population; improved; interest; lifestyle intervention; mHealth; multidisciplinary; novel; patient population; pilot trial; population health; program costs; programs; response; smartphone Application; standard of care; tool

1 PROJECT SUMMARY Millions of U.S. adults living with prediabetes, a high risk state for future type 2 diabetes, do not receive appropriate lifestyle counseling to lower their risk of type 2 diabetes. Mobile health (mHealth) technologies represent a potential scalable solution to address this far-reaching problem. The objective of this project is to compare the real-world effectiveness of a digital diabetes prevention program (dDPP) to standard of care in- person diabetes prevention programs (ipDPPs). This study will test a novel, fully-automated digital health platform (Sweetch Health, Ltd.) that uses artificial intelligence technology to provide just-in-time and adaptive lifestyle change coaching for prediabetic adults. Preliminary evidence from feasibility or observational studies suggests that JITAIs, which are often delivered via smartphone apps by virtue of their ability to provide continuous self-monitoring and feedback, can be effective. However, it is currently not known whether dDPPs that deliver a JITAI are as effective as ipDPPs in improving health outcomes in patients with prediabetes, a susceptible patient population that is positioned to benefit from such an intervention. The overarching goal of this project, therefore, is to compare the effectiveness of the Sweetch digital diabetes prevention program (dDPP) to real-world in-person diabetes prevention programs (ipDPPs) for promoting weight loss, increasing physical activity, and reducing hemoglobin A1C in prediabetic adults. The proposed study addresses an evidence gap in the science of chronic disease prevention and health behavior change and is supported by promising short-term results from a previous pilot trial conducted by our team. Building on our previous study and leveraging the collective expertise of our multidisciplinary study team, we will conduct a randomized controlled trial of 382 overweight/obese, prediabetic adults ages 18-75 with 6 and 12 month follow-up visits: Arm 1 (N=191) will receive the fully automated Sweetch digital health kit (“dDPP” arm) and Arm 2 (N=191) will be referred to a local CDC-recognized ipDPP. Both arms will have physical activity measured serially during the trial using actimetry at baseline and 2 month intervals. We hypothesize that the dDPP will be more effective than the ipDPP for the outcomes of weight loss, physical activity, and lowering of hemoglobin A1C at 6 months, with sustained effects at 12 months. We further hypothesize that the overall engagement and acceptability will be greater in the dDPP, and that the superiority of the dDPP on clinical outcomes will be mediated by higher engagement in this arm. This project will advance chronic disease prevention and behavioral science research by elucidating the extent to which fully-automated digital interventions using artificial intelligence technology can deliver effective, scalable, sustainable, and cost-effective health-promoting behavioral change interventions in high-risk populations. The implications of this fully-automated approach for scalability in diabetes prevention are profound.

1项目总结