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Optimizing Just-in-Time Adaptive Intervention to Improve Dietary Adherence in Behavioral Obesity Treatment: A Micro-randomized Trial

Award Number: R01HL153543
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/01/2020
PERIOD OF PERFORMANCE END DATE: 05/31/2026

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Optimizing Just-in-Time Adaptive Intervention to Improve Dietary Adherence in Behavioral Obesity Treatment: A Micro-randomized Trial - PROJECT SUMMARY/ABSTRACT Behavioral obesity treatment produces clinically significant weight loss and reduced disease risk/severity for many individuals with overweight/obesity and cardiovascular disease. Yet, about half of patients fall short of expected outcomes, which can be largely attributed to lapses from the recommended diet. Our work has shown that dietary lapses (specific instances of nonadherence to dietary goals) are frequent during weight loss attempts (~3-4 times per week), associated with poorer weight losses, and triggered by momentary changing states (e.g., changes in mood or availability of palatable food). Thus, there is a clear need for innovative solutions that can provide dynamic in-the-moment interventions to improve adherence to the prescribed diet in obesity treatment. Our research team was the first to develop a smartphone-based just-in-time adaptive intervention (JITAI) that includes: 1) daily ecological momentary assessment (EMA; repeated sampling via mobile device) of relevant behavioral, psychological, and environmental triggers for lapse; 2) a machine learning algorithm that uses information gathered via EMA to determine real-time lapse risk; & 3) delivery of brief intervention during high-risk moments. Our pilot work revealed that the JITAI was feasible, acceptable, and produced reductions in average lapse frequency. However, we have not yet shown a direct effect of the JITAI on eating behavior in the moment of heightened lapse risk and know little about the types of interventions that are most effective for reducing lapse. We therefore propose to extend our research via a micro- randomized trial (MRT), a methodology that involves random assignment to intervention (or control) at a specific decision point, i.e., when our algorithm predicts heightened risk for a lapse. The MRT will determine whether a specific intervention in a specific moment had its intended effect. We will therefore port our JITAI to a more scalable online platform and conduct a MRT to evaluate the effects of a generic lapse risk alert message and theory-driven just-in-time interventions on dietary lapses. After refinement testing with n=15 to ensure proper technical functioning of our updated JITAI, adults with overweight/obesity (n=159) will participate in a well-established 12-week online obesity treatment program + JITAI, with 12 weeks of JITAI-only follow-up. When an individual is at risk for lapsing s/he will be randomized to no intervention, a generic risk alert, or one of 4 theory-driven interventions with interactive skills training. The outcome of interest will be the occurrence (or lack thereof) of dietary lapse, as measured both subjectively (i.e., via EMA) and objectively (i.e., via wrist- based intake monitoring), in the hours following randomization. Results of the MRT will inform an optimized algorithm for intervention delivery that will drive the finalized JITAI. A future RCT will compare weight loss in obesity treatment with and without the optimized JITAI. This highly innovative approach will advance the science of adherence by supporting the development of sophisticated theoretical models of adherence behavior and informing JITAIs that target adherence to other health behaviors (e.g., medication, activity goals).


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: 2025 ( Subtotal = $0 )
2025	2023	THE MIRIAM HOSPITAL	164 SUMMIT AVE	PROVIDENCE	RI	02906	PROVIDENCE	USA	Cardiovascular Diseases Research	000	4	6/18/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	THE MIRIAM HOSPITAL	164 SUMMIT AVE	PROVIDENCE	RI	02906	PROVIDENCE	USA	Cardiovascular Diseases Research	000	4	7/17/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $631,724 )
2023	2023	THE MIRIAM HOSPITAL	164 SUMMIT AVE	PROVIDENCE	RI	02906	PROVIDENCE	USA	Cardiovascular Diseases Research	000	4	5/12/2023	NON-COMPETING CONTINUATION	$631,724
														Subtotal = $631,724

Issue Date FY: 2022 ( Subtotal = $620,820 )
2022	2022	THE MIRIAM HOSPITAL	164 SUMMIT AVE	PROVIDENCE	RI	02906	PROVIDENCE	USA	Cardiovascular Diseases Research	000	3	5/14/2022	NON-COMPETING CONTINUATION	$620,820
														Subtotal = $620,820

Issue Date FY: 2021 ( Subtotal = $607,792 )
2021	2021	THE MIRIAM HOSPITAL	164 SUMMIT AVE	PROVIDENCE	RI	02906	PROVIDENCE	USA	Cardiovascular Diseases Research	000	2	6/11/2021	NON-COMPETING CONTINUATION	$607,792
														Subtotal = $607,792

Issue Date FY: 2020 ( Subtotal = $727,923 )
2020	2020	THE MIRIAM HOSPITAL	164 SUMMIT AVE	PROVIDENCE	RI	02906	PROVIDENCE	USA	Cardiovascular Diseases Research	000	1	7/24/2020	NEW	$727,923
														Subtotal = $727,923

Grand Total All Awards = $2,588,259

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Optimizing Just-in-Time Adaptive Intervention to Improve Dietary Adherence in Behavioral Obesity Treatment: A Micro-randomized Trial

Award Number: R01HL153543

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/01/2020

PERIOD OF PERFORMANCE END DATE: 05/31/2026

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