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

NCT06107387 | Completed

• 2 other identifiers: 2000033103000
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Binge Eating; Binge-Eating Disorder; Overweight or Obesity

Outcome Measures

Primary Outcomes (2)

• Attendance

  Number of participants attending \>75% of sessions

  4 months

• Retention

  Number of participants who attend through the end of treatment

  4 months

Secondary Outcomes (2)

• Treatment Credibility

  1 week

• Treatment Satisfaction

  4 months

Study Arms (1)

Binge Eating Self-help for Teens

EXPERIMENTAL

Participants will have 16 guided self-help sessions (4 months; weekly sessions for adolescents with parents joining monthly). Participants will complete daily self-monitoring of eating behaviors (timing of meals and snacks; whether or not a binge occurred) throughout treatment. Treatment sessions involve a self-help component, which includes brief videos that participants watch at home. Treatment sessions also involve a guidance component (brief consultation), 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

Interventions

Binge Eating Self-help for Teens BEHAVIORAL

Guided self-help intervention

Also known as: BEST

Binge Eating Self-help for Teens

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Bulimia; Binge-Eating Disorder; Overweight; Obesity

Condition Hierarchy (Ancestors)

Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding and Eating Disorders; Mental Disorders; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Study Officials

• Janet A Lydecker, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: October 30, 2023
• Study Start: February 14, 2024
• Primary Completion: June 26, 2025
• Study Completion: June 26, 2025
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)