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

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

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.

Study Overview

• Status: Completed
• Conditions: Binge-Eating Disorder; Overweight or Obesity; Binge Eating
• Intervention / Treatment: Behavioral: Binge Eating Self-help for Teens

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 4 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Binge Eating Self-help for Teens; 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; Guided self-help intervention; Other Names: BEST

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attendance	Number of participants attending >75% of sessions	4 months
Retention	Number of participants who attend through the end of treatment	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Credibility	Adolescent/parent treatment credibility (moderate or higher, study-specific face-valid treatment credibility form)	1 week
Treatment Satisfaction	Adolescent/parent/clinician treatment satisfaction (acceptable or higher, Client Satisfaction Questionnaire)	4 months

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Janet A Lydecker, PhD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2024
• Primary Completion (Actual): June 26, 2025
• Study Completion (Actual): June 26, 2025

Study Registration Dates

• First Submitted: October 24, 2023
• First Submitted That Met QC Criteria: October 24, 2023
• First Posted (Actual): October 30, 2023

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nutrition Disorders; Overnutrition; Body Weight; Hyperphagia; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Bulimia; Obesity; Binge-Eating Disorder
• Other Study ID Numbers: 2000033103; 000 (Other Identifier: YCTG)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a pilot study. We are prioritizing individuals' privacy because they are children and binge eating and weight can be stigmatizing. We will consider requests to share individual-level data from other researchers if they are consistent with privacy protections.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No