Binge EatingEarly Phase 1NCT07521072
Testing an Intervention for College Students With Food Insecurity and Binge Eating
A Early Phase 1 study testing novel binge eating intervention for college students experiencing food insecurity. in people with Binge Eating, run by Virginia Polytechnic Institute and State University.
Trial summary
This study is being conducted to test a new intervention. We are interested in whether it is easy to use and complete and whether you find it helpful in reducing concerns about your eating. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Binge Eating
- What is being tested?
- novel binge eating intervention for college students experiencing food insecurity.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 May 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- college student status, ages 18-30 years, current food insecurity, current binge eating, and interest in changing binge eating behaviors. Food security status will be determined by 2-item the Hunger Vital Sign screening, which demonstrates high sensitivity and specificity in identifying individuals with food insecurity; scores must report mild or greater food insecurity to participate. Binge eating and related impairment will be evaluated by the Eating Disorder Diagnostic Scale and the Clinical Impairment Assessment, and the binge eating items from the Eating Disorder Examination interview. Eating behaviors must be consistent with a DSM-5-TR binge spectrum eating disorder diagnosis, whereby an individual reports binge eating episodes at minimum one time per week for the current month and at least two times per month for the prior two months, to participate. Participants will be permitted to report other mild level symptoms of psychopathology due to the high comorbidity between anxiety, depression, and binge eating among individuals with food insecurity.
Who cannot join
- Severe levels of anxiety and depression symptoms.
About this study
Official title: Building an Intervention for College Students With Food Insecurity and Binge Eating
This study is being conducted to test a new intervention. We are interested in whether it is easy to use and complete and whether you find it helpful in reducing concerns about your eating.
- Conditions
- Binge Eating
- Being tested
- novel binge eating intervention for college students experiencing food insecurity.
- Medical subject headings
- Bulimia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
novel binge eating intervention for college students experiencing food insecurity.Behavioural
this intervention uses aspects of cognitive behavorial therapy for eating disorders combined with compassion-focused therapy techniques.
| Study group | Role | What they receive |
|---|---|---|
| Binge eating intervention | Experimental | This arm will test a novel binge eating intervention for college students experiencing food insecurity. Receives: Behavioral: novel binge eating intervention for college students experiencing food insecurity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Compassion Scale (SCS)
SCS is a 26-item survey that measures how an individual perceives themselves, and whether they respond with self-criticism or self-compassion in times of suffering, failure, and perceived inadequacy.
Measured: 3 weeks
Experiences of Shame Scale (ESS)
The ESS is a 25-item survey that assesses an individual's perceived feelings of shame about themselves, their behaviors, and their body weight and shape; higher scores indicate greater feelings of shame.
Measured: 3 weeks
Systems Usability Scale (SUS)
Measures usability of an intervention
Measured: 3 weeks
Digital Behavioral Change Interventions (DBCI) Engagement Scale
Measures intervention engagement
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge EatingStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heather Davis, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07521072
- Sponsor's protocol ID
- PK2RNLRK
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building an Intervention for College Students With Food Insecurity and Binge Eating
- ClinicalTrials.gov ID
- NCT07521072
- Acronym / sponsor ID
- PK2RNLRK
- Conditions
- Binge Eating
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to test a new intervention. We are interested in whether it is easy to use and complete and whether you find it helpful in reducing concerns about your eating.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Binge eating intervention | Experimental | Behavioral: novel binge eating intervention for college students experiencing food insecurity.This arm will test a novel binge eating intervention for college students experiencing food insecurity. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- college student status, ages 18-30 years, current food insecurity, current binge eating, and interest in changing binge eating behaviors. Food security status will be determined by 2-item the Hunger Vital Sign screening, which demonstrates high sensitivity and specificity in identifying individuals with food insecurity; scores must report mild or greater food insecurity to participate. Binge eating and related impairment will be evaluated by the Eating Disorder Diagnostic Scale and the Clinical Impairment Assessment, and the binge eating items from the Eating Disorder Examination interview. Eating behaviors must be consistent with a DSM-5-TR binge spectrum eating disorder diagnosis, whereby an individual reports binge eating episodes at minimum one time per week for the current month and at least two times per month for the prior two months, to participate. Participants will be permitted to report other mild level symptoms of psychopathology due to the high comorbidity between anxiety, depression, and binge eating among individuals with food insecurity.
Key exclusion criteria (1 listed)
- Severe levels of anxiety and depression symptoms.
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 |
|---|---|---|
| novel binge eating intervention for college students experiencing food insecurity.this intervention uses aspects of cognitive behavorial therapy for eating disorders combined with compassion-focused therapy techniques. | Behavioural | Binge eating intervention |
Primary outcome
Self-Compassion Scale (SCS)
Time frame: 3 weeks
SCS is a 26-item survey that measures how an individual perceives themselves, and whether they respond with self-criticism or self-compassion in times of suffering, failure, and perceived inadequacy.
Experiences of Shame Scale (ESS)
Time frame: 3 weeks
The ESS is a 25-item survey that assesses an individual's perceived feelings of shame about themselves, their behaviors, and their body weight and shape; higher scores indicate greater feelings of shame.
Systems Usability Scale (SUS)
Time frame: 3 weeks
Measures usability of an intervention
Digital Behavioral Change Interventions (DBCI) Engagement Scale
Time frame: 3 weeks
Measures intervention engagement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing novel binge eating intervention for college students experiencing food insecurity. in people with Binge Eating, run by Virginia Polytechnic Institute and State University.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Self-Compassion Scale (SCS) (time frame: 3 weeks). The study lists 4 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 9 Apr 2026.