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Supplement to Effectiveness of Digital Versus In-Person Diabetes Prevention Programs

Award Number: R01DK125780
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2023 ( Subtotal = $818,524 )
2023	2023	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	7/4/2023	NON-COMPETING CONTINUATION	$704,140
2023	2023	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	4	8/23/2023	SUPPLEMENT FOR EXPANSION	$114,384
														Subtotal = $818,524

Issue Date FY: 2022 ( Subtotal = $710,174 )
2022	2022	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	6/17/2022	NON-COMPETING CONTINUATION	$710,174
														Subtotal = $710,174

Issue Date FY: 2021 ( Subtotal = $714,718 )
2021	2021	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	6/4/2021	NON-COMPETING CONTINUATION	$714,718
														Subtotal = $714,718

Issue Date FY: 2020 ( Subtotal = $733,116 )
2020	2020	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	9/9/2020	NEW	$733,116
														Subtotal = $733,116

Grand Total All Awards = $2,976,532

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Supplement to Effectiveness of Digital Versus In-Person Diabetes Prevention Programs

Award Number: R01DK125780

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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