N/A
N=50
Cognitive Behavioral Therapy for Adolescent Binge Eating and Loss of Control Eating
Binge Eating · Eating Disorders in Adolescence · Overweight and Obesity
Bottom Line
View on ClinicalTrials.gov: NCT04088097 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Binge (Loss-of-control) Eating Episode Frequency — 1.52; 6.05 episodes of behavior — p=.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cognitive-Behavioral Therapy for Adolescent Binge/Loss-of-Control Eating (Behavioral); Control Condition (Other)
- Age
- Pediatric · 12+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Binge (Loss-of-control) Eating Episode Frequency |
2.04; 5.94 | .03 sig |
| PRIMARY Weight (e.g., Percent Loss) |
.02; .01 | — |
| SECONDARY Binge (Loss-of-control) Eating Episode Frequency |
2.04; 5.94 | .03 sig |
| SECONDARY Weight (e.g., Percent Loss) |
.02; .01 | — |
Summary
This study will develop and test a cognitive-behavioral intervention for adolescents with binge/loss-of-control eating.
Eligibility Criteria
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;
- Be available for participation in the study for 7 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.
Data sourced from ClinicalTrials.gov (NCT04088097). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.