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Clinical trial

Project VIBE: Virtual Intervention for Binge Eating in Adolescents

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT06819813

Active, not recruitingNot applicableInterventional

What this study is about

The aim of this project is to pilot test a novel mobile app intervention for adolescents with dysregulated eating behaviors and elevated weight status. This intervention will incorporate evidence-informed strategies targeting self-regulation into cognitive-behavioral treatment for maladaptive eating. Adolescents will use the app for 16 weeks and provide feedback on its usability and effectiveness in managing dysregulated eating.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age13 Years to 19 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity, Binge-Eating Disorder, Binge Eating

Full registry criteria

Inclusion Criteria: * BMI≥75th percentile for their age and sex * Report recent loss of control eating and/or overeating (≥3 episodes of either type of eating behavior in the past 3 months) * Have an email address, Smartphone, and regular access to the internet * Be willing and able to measure their height and weight prior to study enrollment Exclusion Criteria: * Report more than 2 instances of compensatory behavior (e.g. diuretics, laxatives, vomiting, driven exercise) in the past 3 months * Not fluent in English at a third-grade reading level or higher * Currently taking medications known to affect weight or appetite or concurrently involved in treatment for eating or weight disorders * Meet criteria for a medical or psychiatric condition (e.g., diabetes, bulimia nervosa) known to significantly affect eating or weight, aside from binge eating disorder * Developmental or cognitive delay precluding participation in the intervention * Currently pregnant or lactating

Treatments and study arms

Feasibility/Efficacy Testing

Behavioral

This digital intervention will include elements of adapted cognitive-behavioral treatment for adolescent binge eating and weight control, with a focus on self-regulation and skills use.

Primary outcomes

Usability of interventionWeek 16

Perceptions that the intervention is or would be useful, useable, and satisfactory will be measured by the System Usability Scale.

Acceptability of interventionWeek 16

Perceptions that the intervention is or would be useful, useable, and satisfactory will be measured by the Usefulness, Satisfaction, and Ease of use questionnaire (USE).

Body mass index percentileThrough study completion (up to 9 months)

Adolescents will have their height and weight measured to calculate body mass index percentile using nationally representative growth charts and accompanying procedures. These data will be collected at each of the 4 major time points (pre-intervention assessment, mid-intervention assessment, post-intervention assessment, and 4-month follow up assessment).

Dysregulated eatingThrough study completion (up to 9 months)

Dysregulated eating (overeating and loss of control eating episodes) will be measured using the Eating Disorder Examination (EDE; interview and questionnaire). The EDE features 4 subscales that are rated on a 7-point forced-choice format (0-6), with higher scores reflecting greater severity or frequency. These measures will be completed at each of the 4 major time points (pre-intervention assessment, mid-intervention assessment, post-intervention assessment, and 4-month follow up assessment).

Study locations

2 locations were listed when this page was built. The first 40 are shown.

Northwestern University🇺🇸 Chicago, Illinois, United States
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University of Pittsburgh🇺🇸 Pittsburgh, Pennsylvania, United States
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