Binge EatingNCT06348251
FoodSteps for Binge Eating & Food Insecurity
A study testing FoodSteps in people with Binge Eating and Type 2 Diabetes, run by Northwestern University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Binge Eating, Type 2 Diabetes, Food Insecurity
- What is being tested?
- FoodSteps
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2024to 20 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- Has a smartphone with Internet access and capacity for calls and text messaging
- Has a valid email address
- Not pregnant
- English-speaking
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
About this study
Official title: 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.
- Conditions
- Binge Eating, Type 2 Diabetes, Food Insecurity
- Being tested
- FoodSteps
- Medical subject headings
- Bulimia, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FoodStepsBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Behavioral intervention | Other | Not described Receives: Behavioral: FoodSteps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Feasibility assessed by study recruitment and retention rates
Measured: 16 weeks
Study Retention Rate
Feasibility assessed by study recruitment and retention rates
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start26 Mar 2024
- Primary completion20 Nov 2024
- Study completion20 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Binge EatingStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Graham, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348251
- Sponsor's protocol ID
- STU00219612
- Status last verified
- Jan 2026
- First submitted
- 30 Mar 2024
- Last updated
- 28 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Digital Intervention for Binge Eating and Weight Management Among Adults With Food Insecurity
- ClinicalTrials.gov ID
- NCT06348251
- Acronym / sponsor ID
- STU00219612
- Conditions
- Binge Eating, Type 2 Diabetes, Food Insecurity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- 20 Nov 2024 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 4 Apr 2024 (actual)
- Results
- Posted 28 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behavioral intervention | Other | Behavioral: FoodSteps |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FoodStepsParticipants 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 | Behavioural | Behavioral intervention |
Primary outcome
Recruitment Rate
Time frame: 16 weeks
Feasibility assessed by study recruitment and retention rates
Study Retention Rate
Time frame: 16 weeks
Feasibility assessed by study recruitment and retention rates
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FoodSteps in people with Binge Eating and Type 2 Diabetes, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.