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Clinical Trials/NCT06107387
NCT06107387
Completed
Not Applicable

Binge Eating Self-help for Teens (BEST): A Pilot and Feasibility Test of an Online Behavioral Intervention for Adolescents With Binge Eating and Elevated Weight

Yale University1 site in 1 country8 target enrollmentFebruary 14, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Binge Eating
Sponsor
Yale University
Enrollment
8
Locations
1
Primary Endpoint
Attendance
Status
Completed
Last Updated
4 months ago

Overview

Brief Summary

This study is a pilot clinical trial of a new guided self-help CBT for binge eating. Participants will complete an intake assessment; following determination of eligibility, participants will then complete four months of treatment (weekly guided self-help sessions). At the end of treatment, participants will complete an interview with a research clinician to assess outcomes.

Registry
clinicaltrials.gov
Start Date
February 14, 2024
End Date
June 26, 2025
Last Updated
4 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • To be included, adolescents must:
  • Be in the age range ≥12 years old and ≤17 years old;
  • Have a BMI that places them above the 85th percentile based on their age and sex;
  • Report 2 episodes of binge/LOC eating (feeling a loss of control while eating) per month for the past 3 months;
  • Be otherwise-healthy youth (i.e., no uncontrolled or serious medical conditions);
  • Read, comprehend, and write English at a sufficient level to complete study-related materials;
  • Provide a signed and dated written assent prior to study participation;
  • Provide a signed and dated written consent from one parent prior to study participant; and
  • Be available for participation in the study for 4 months.

Exclusion Criteria

  • Prospective participants will be excluded if the adolescent:
  • Has a medical or psychiatric condition that would require hospitalization or intensive care (e.g., neurological disorder, psychotic disorders, suicidality);
  • Has a medical or psychiatric condition that would prohibit them from engaging in behavioral treatment or moderate physical activity (e.g., cardiovascular problems);
  • Has uncontrolled medical condition(s) (e.g., uncontrolled diabetes or hypertension);
  • Is pregnant or breastfeeding;
  • Is taking medication(s) or participating in treatment(s) that could influence weight or appetite;
  • Began taking hormonal contraceptives less than 3 months prior;
  • Has a developmental or cognitive disorder (e.g., autism spectrum disorder);
  • Has a concurrent feeding/eating disorder (e.g., bulimia nervosa); or
  • Is participating in another clinical research study.

Outcomes

Primary Outcomes

Attendance

Time Frame: 4 months

Number of participants attending \>75% of sessions

Retention

Time Frame: 4 months

Number of participants who attend through the end of treatment

Secondary Outcomes

  • Treatment Credibility(1 week)
  • Treatment Satisfaction(4 months)

Study Sites (1)

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