NCT07521072

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for early_phase_1

Timeline
17mo left

Started Dec 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 9, 2026

Completed
8 months until next milestone

Study Start

First participant enrolled

December 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

April 2, 2026

Last Update Submit

April 2, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    3 weeks

  • Systems Usability Scale (SUS)

    Measures usability of an intervention

    3 weeks

  • Digital Behavioral Change Interventions (DBCI) Engagement Scale

    Measures intervention engagement

    3 weeks

Study Arms (1)

Binge eating intervention

EXPERIMENTAL

This arm will test a novel binge eating intervention for college students experiencing food insecurity.

Behavioral: novel binge eating intervention for college students experiencing food insecurity.

Interventions

this intervention uses aspects of cognitive behavorial therapy for eating disorders combined with compassion-focused therapy techniques.

Binge eating intervention

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Severe levels of anxiety and depression symptoms.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Bulimia

Condition Hierarchy (Ancestors)

HyperphagiaSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 2, 2026

First Posted

April 9, 2026

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

May 1, 2028

Last Updated

April 9, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share