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A Micro-Randomized Trial to Optimize Just-in-Time Adaptive Intervention for Binge Eating & Weight-related Behaviors

Award Number: R01DK133300
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/01/2022
PERIOD OF PERFORMANCE END DATE: 05/31/2027

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A Micro-Randomized Trial to Optimize Just-in-Time Adaptive Intervention for Binge Eating & Weight-related Behaviors - Two in five U.S. adults have obesity, and up to 30% of treatment-seeking adults with obesity engage in binge eating, an eating disorder behavior characterized by eating a large amount of food and experiencing a loss of control while eating. First-line interventions are face-to-face treatments, but current approaches commonly fail to address both conditions and cannot reach all people in need. To fill this gap, we designed FoodSteps, the first intervention for both obesity and binge eating, delivered by mobile device to increase scalability. We integrated key mechanisms of behavioral and psychological treatments to provide a personalized medicine approach that intervenes on five evidence-based treatment targets. Each week, users select a target and create a plan for how they will practice that target to change their behavior. Our pilot data show FoodSteps is engaging with high rates of completion and compliance, and intervening on the targets improves weekly binge eating and weight on average, but rates are suboptimal. Our data indicate more precise intervention is needed, but three challenges impede achieving this goal. It is unknown 1) which evidence-based targets are most impactful for which people; and 2) in what sequence; as well as 3) how best to deliver targets to propel users to change their behavior. We will resolve these challenges with a micro-randomized trial, the methodologically ideal design because it uses repeated randomization to inform how to precisely intervene based on individual needs. Adults with obesity and recurrent binge eating will receive FoodSteps for 16 weeks. Each week, 1 of the 5 targets will be randomly delivered to each user, to identify which targets work for whom (Aim 1) and in what sequence (Aim 2). Weekly targets also will be randomly delivered either as a recommended target users can select or as an assigned target, to identify how to deliver targets to propel behavior change (Aim 3). We will assess time-varying user characteristics as moderators to inform the development of personalized algorithms to tailor interventions to user needs over time. Our outcomes of interest are weekly changes in binge eating, since it is a behavior that puts overall weight loss at risk, and change in weight long-term (Aim 4). Our data will provide the infrastructure to build a just-in-time adaptive intervention (JITAI) capable of delivering highly personalized intervention for binge eating and weight-related behaviors at a critical point in the behavior change process; we will test the JITAI in a future trial. This trial furthers NIH and NIDDK’s mission to advance treatment via more precise approaches by specifying which treatment targets drive behavior change, led by a team expert in optimizing digital interventions, intervening on obesity and binge eating, and conducting micro- randomized trials. Results have implications beyond FoodSteps given the role of these targets and processes for behavior change broadly, and will propel personalized medicine by informing sophisticated models for achieving the ultimate goal of personalizing the delivery of digital and non-digital interventions.


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 = $650,662 )
2025	2025	NORTHWESTERN UNIVERSITY	633 CLARK ST	EVANSTON	IL	60208	COOK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	8/1/2025	NON-COMPETING CONTINUATION	$650,662
														Subtotal = $650,662

Issue Date FY: 2024 ( Subtotal = $641,652 )
2024	2024	NORTHWESTERN UNIVERSITY	633 CLARK ST	EVANSTON	IL	60208	COOK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	7/8/2024	NON-COMPETING CONTINUATION	$641,652
														Subtotal = $641,652

Issue Date FY: 2023 ( Subtotal = $689,627 )
2023	2023	NORTHWESTERN UNIVERSITY	633 CLARK ST	EVANSTON	IL	60208	COOK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	5/26/2023	NON-COMPETING CONTINUATION	$689,627
														Subtotal = $689,627

Issue Date FY: 2022 ( Subtotal = $729,388 )
2022	2022	NORTHWESTERN UNIVERSITY	633 CLARK ST	EVANSTON	IL	60208	COOK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	7/25/2022	NEW	$729,388
														Subtotal = $729,388

Grand Total All Awards = $2,711,329

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A Micro-Randomized Trial to Optimize Just-in-Time Adaptive Intervention for Binge Eating & Weight-related Behaviors

Award Number: R01DK133300

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/01/2022

PERIOD OF PERFORMANCE END DATE: 05/31/2027

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