- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06349460
Trial to Optimize Just-in-Time Adaptive Intervention for Binge Eating & Weight-related Behaviors
December 11, 2025 updated by: Andrea Graham, Northwestern University
A Micro-Randomized Trial to Optimize Just-in-Time Adaptive Intervention for Binge Eating & Weight-related Behaviors
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern University Feinberg School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Increase healthy eating behaviors - Assigned
Individuals will be assigned to increase healthy eating behaviors that week.
|
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.
|
|
Experimental: Increase healthy eating behaviors - Recommended
Individuals will be recommend to increase healthy eating behaviors that week.
|
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.
|
|
Experimental: Increase physical activity - Assigned
Individuals will be assigned to increase physical activity that week.
|
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.
|
|
Experimental: Increase physical activity - Recommended
Individuals will be recommended to increase physical activity that week.
|
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.
|
|
Experimental: Limit unhealthy dieting behaviors - Assigned
Individuals will be assigned to limit unhealthy dieting behaviors that week.
|
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.
|
|
Experimental: Limit unhealthy dieting behaviors - Recommended
Individuals will be recommended to limit unhealthy dieting behaviors that week.
|
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.
|
|
Experimental: Improve self-image - Assigned
Individuals will be assigned to improve self-image that week.
|
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.
|
|
Experimental: Improve self-image - Recommended
Individuals will be recommended to improve self-image that week.
|
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.
|
|
Experimental: Improve mood - Assigned
Individuals will be assigned to improve mood that week.
|
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.
|
|
Experimental: Improve mood - Recommended
Individuals will be recommended to improve mood that week.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weekly change in binge eating
Time Frame: 1 week
|
Change in number of binge eating episodes
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 21, 2024
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Study Registration Dates
First Submitted
March 30, 2024
First Submitted That Met QC Criteria
March 30, 2024
First Posted (Actual)
April 5, 2024
Study Record Updates
Last Update Posted (Actual)
December 17, 2025
Last Update Submitted That Met QC Criteria
December 11, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU00216998
- R01DK133300 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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