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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Binge Eating, Binge-Eating Disorder, Overweight or Obesity

Intervention / Treatment
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* Behavioral: Binge Eating Self-help for Teens


Participation Criteria
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Eligibility Criteria
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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 5 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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Binge Eating Self-help for Teens<br>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<br>* Guided self-help intervention<br>* Other names: BEST;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attendance | Number of participants attending >75% of sessions | 5 months | 
| Retention | Number of participants who attend through the end of treatment | 5 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) | 5 months |