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

NCT ID: NCT06349460

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-21

Study Completion Date

2026-06-30

Brief Summary

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The purpose of this study is to conduct a micro-randomized trial to learn which evidence-based targets within a mobile intervention for binge eating and weight-related behaviors are most impactful for which people and in what sequence.

Detailed Description

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Conditions

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Binge Eating Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

In this micro-randomized trial, participants will have 2 consecutive, independent micro-randomizations at the time of target selection each week for 16 weeks: namely, 1 of 5 treatment targets will be randomly delivered, either as a recommended or assigned target, to each user, of equal probability per randomization.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Increase physical activity - Recommended

Individuals will be recommended to increase physical activity that week.

Group Type EXPERIMENTAL

FoodSteps behavioral intervention

Intervention Type BEHAVIORAL

Behavioral intervention that targets binge eating and weight-related behaviors. Each week, users are recommended or assigned one of five targets, set a relevant goal, and track their progress. If a target is recommended, the user can choose to select that target or a different target.

Limit unhealthy dieting behaviors - Assigned

Individuals will be assigned to limit unhealthy dieting behaviors that week.

Group Type EXPERIMENTAL

FoodSteps behavioral intervention

Intervention Type BEHAVIORAL

Behavioral intervention that targets binge eating and weight-related behaviors. Each week, users are recommended or assigned one of five targets, set a relevant goal, and track their progress. If a target is recommended, the user can choose to select that target or a different target.

Limit unhealthy dieting behaviors - Recommended

Individuals will be recommended to limit unhealthy dieting behaviors that week.

Group Type EXPERIMENTAL

FoodSteps behavioral intervention

Intervention Type BEHAVIORAL

Behavioral intervention that targets binge eating and weight-related behaviors. Each week, users are recommended or assigned one of five targets, set a relevant goal, and track their progress. If a target is recommended, the user can choose to select that target or a different target.

Improve self-image - Assigned

Individuals will be assigned to improve self-image that week.

Group Type EXPERIMENTAL

FoodSteps behavioral intervention

Intervention Type BEHAVIORAL

Behavioral intervention that targets binge eating and weight-related behaviors. Each week, users are recommended or assigned one of five targets, set a relevant goal, and track their progress. If a target is recommended, the user can choose to select that target or a different target.

Improve self-image - Recommended

Individuals will be recommended to improve self-image that week.

Group Type EXPERIMENTAL

FoodSteps behavioral intervention

Intervention Type BEHAVIORAL

Behavioral intervention that targets binge eating and weight-related behaviors. Each week, users are recommended or assigned one of five targets, set a relevant goal, and track their progress. If a target is recommended, the user can choose to select that target or a different target.

Improve mood - Assigned

Individuals will be assigned to improve mood that week.

Group Type EXPERIMENTAL

FoodSteps behavioral intervention

Intervention Type BEHAVIORAL

Behavioral intervention that targets binge eating and weight-related behaviors. Each week, users are recommended or assigned one of five targets, set a relevant goal, and track their progress. If a target is recommended, the user can choose to select that target or a different target.

Improve mood - Recommended

Individuals will be recommended to improve mood that week.

Group Type EXPERIMENTAL

FoodSteps behavioral intervention

Intervention Type BEHAVIORAL

Behavioral intervention that targets binge eating and weight-related behaviors. Each week, users are recommended or assigned one of five targets, set a relevant goal, and track their progress. If a target is recommended, the user can choose to select that target or a different target.

Increase healthy eating behaviors - Assigned

Individuals will be assigned to increase healthy eating behaviors that week.

Group Type EXPERIMENTAL

FoodSteps behavioral intervention

Intervention Type BEHAVIORAL

Behavioral intervention that targets binge eating and weight-related behaviors. Each week, users are recommended or assigned one of five targets, set a relevant goal, and track their progress. If a target is recommended, the user can choose to select that target or a different target.

Increase healthy eating behaviors - Recommended

Individuals will be recommend to increase healthy eating behaviors that week.

Group Type EXPERIMENTAL

FoodSteps behavioral intervention

Intervention Type BEHAVIORAL

Behavioral intervention that targets binge eating and weight-related behaviors. Each week, users are recommended or assigned one of five targets, set a relevant goal, and track their progress. If a target is recommended, the user can choose to select that target or a different target.

Increase physical activity - Assigned

Individuals will be assigned to increase physical activity that week.

Group Type EXPERIMENTAL

FoodSteps behavioral intervention

Intervention Type BEHAVIORAL

Behavioral intervention that targets binge eating and weight-related behaviors. Each week, users are recommended or assigned one of five targets, set a relevant goal, and track their progress. If a target is recommended, the user can choose to select that target or a different target.

Interventions

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FoodSteps behavioral intervention

Behavioral intervention that targets binge eating and weight-related behaviors. Each week, users are recommended or assigned one of five targets, set a relevant goal, and track their progress. If a target is recommended, the user can choose to select that target or a different target.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Adults age 18 years or older
* Obesity (BMI ≥30)
* Recurrent binge eating (≥12 episodes in the past 3 months)
* Interested in losing weight and reducing binge eating
* Willing to use a mobile application
* Has a smartphone with Internet access and capacity for calls and text messaging
* Has a valid email address
* Has access to a scale
* Not pregnant
* English-speaking

Exclusion Criteria

* Diagnosis for which the study/intervention is not clinically indicated
* Not currently receiving clinical services for weight management or binge eating
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Andrea Graham

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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Ortega A, Rooper IR, Massion T, Azubuike C, Lipman LD, Lakhtakia T, Camino MK, Parsons LM, Tack E, Alshurafa N, Kay M, Graham AK. Co-designing prediction data visualizations for a digital binge eating intervention. Transl Behav Med. 2025 Jan 16;15(1):ibaf009. doi: 10.1093/tbm/ibaf009.

Reference Type DERIVED
PMID: 40167045 (View on PubMed)

Other Identifiers

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R01DK133300

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STU00216998

Identifier Type: -

Identifier Source: org_study_id