- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06348251
FoodSteps for Binge Eating & Food Insecurity
January 27, 2026 updated by: Andrea Graham, Northwestern University
Evaluating a Digital Intervention for Binge Eating and Weight Management Among Adults With Food Insecurity
The purpose of this study is to conduct a pilot trial of a mobile intervention that targets binge eating and weight-related behaviors, to determine the feasibility, acceptability, and preliminary efficacy of the intervention among adults with recurrent binge eating, diabetes, and food insecurity.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
31
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
- Recurrent binge eating (≥12 episodes in the past 3 months)
- Type 2 diabetes mellitus
- Food insecure status (e.g. difficulty accessing food)
- 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
- Not pregnant
- English-speaking
Exclusion Criteria:
- Diagnosis for which the study/intervention is not clinically indicated
- Currently receiving clinical services for weight management or binge eating
- Started or recently (within the past month) changed dosage of a medication for binge eating, weight management, or diabetes
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Behavioral intervention
|
Participants will get access to the FoodSteps digital intervention with coaching for 16 weeks and receive a weekly stipend benefit to aid with implementing health behavior changes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recruitment Rate
Time Frame: 16 weeks
|
Feasibility assessed by study recruitment and retention rates
|
16 weeks
|
|
Study Retention Rate
Time Frame: 16 weeks
|
Feasibility assessed by study recruitment and retention rates
|
16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 26, 2024
Primary Completion (Actual)
November 20, 2024
Study Completion (Actual)
November 20, 2024
Study Registration Dates
First Submitted
March 30, 2024
First Submitted That Met QC Criteria
March 30, 2024
First Posted (Actual)
April 4, 2024
Study Record Updates
Last Update Posted (Actual)
January 28, 2026
Last Update Submitted That Met QC Criteria
January 27, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU00219612
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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