BEST: Binge Eating Self-help for Teens ONLINE Pilot and Feasibility Study

Sponsor
Yale University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06107387
Collaborator
(none)
20
1
24

Study Details

Study Description

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 five months of treatment. The first month of treatment is self-monitoring of eating behavior, followed by four months of weekly guided self-help sessions. At the end of treatment, participants will complete an interview with a research clinician to assess outcomes.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Binge Eating Self-help for Teens
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Binge Eating Self-help for Teens

Participants will begin treatment with one month of daily self-monitoring of eating behaviors (timing of meals and snacks; whether or not a binge occurred). Then, participants will have 16 guided self-help sessions (4 months; weekly sessions for adolescents with parents joining monthly). Treatment sessions involve a self-help component, which includes brief videos that participants watch at home, accompanied by interactive forms. Treatment sessions also involve a guidance component, which is 15-30 minutes on a secure videoconferencing platform (e.g., Zoom) between the therapist and the participant. These sessions focus on clarifying material, reviewing self-monitoring and looking for patterns, and problem-solving maladaptive thinking patterns and binge behaviors.

Behavioral: Binge Eating Self-help for Teens
Guided self-help intervention
Other Names:
  • BEST
  • Outcome Measures

    Primary Outcome Measures

    1. Attendance [5 months]

      Number of participants attending >75% of sessions

    2. Retention [5 months]

      Number of participants who attend through the end of treatment

    Secondary Outcome Measures

    1. Treatment Credibility [1 week]

      Adolescent/parent treatment credibility (moderate or higher)

    2. Treatment Satisfaction [5 months]

      Adolescent/parent/clinician treatment satisfaction (acceptable or higher, Client Satisfaction Questionnaire)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria: To be included, adolescents must:
    1. Be in the age range ≥12 years old and ≤17 years old;

    2. Have a BMI that places them above the 85th percentile based on their age and sex;

    3. Report 2 episodes of binge/LOC eating (feeling a loss of control while eating) per month for the past 3 months;

    4. Be otherwise-healthy youth (i.e., no uncontrolled or serious medical conditions);

    5. Read, comprehend, and write English at a sufficient level to complete study-related materials;

    6. Provide a signed and dated written assent prior to study participation;

    7. Provide a signed and dated written consent from one parent prior to study participant; and

    8. Be available for participation in the study for 5 months.

    Exclusion Criteria: Prospective participants will be excluded if the adolescent:
    1. Has a medical or psychiatric condition that would require hospitalization or intensive care (e.g., neurological disorder, psychotic disorders, suicidality);

    2. Has a medical or psychiatric condition that would prohibit them from engaging in behavioral treatment or moderate physical activity (e.g., cardiovascular problems);

    3. Has uncontrolled medical condition(s) (e.g., uncontrolled diabetes or hypertension);

    4. Is pregnant or breastfeeding;

    5. Is taking medication(s) or participating in treatment(s) that could influence weight or appetite;

    6. Began taking hormonal contraceptives less than 3 months prior;

    7. Has a developmental or cognitive disorder (e.g., autism spectrum disorder);

    8. Has a concurrent feeding/eating disorder (e.g., bulimia nervosa); or

    9. Is participating in another clinical research study.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Yale University

    Investigators

    • Principal Investigator: Janet A Lydecker, PhD, Yale School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yale University
    ClinicalTrials.gov Identifier:
    NCT06107387
    Other Study ID Numbers:
    • 2000033103
    First Posted:
    Oct 30, 2023
    Last Update Posted:
    Oct 30, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 30, 2023