Clinical trial NCT04088097: Cognitive Behavioral Therapy for Adolescent Binge Eating and Loss of Control Eating
Official title: Development and Initial Efficacy Testing of a Cognitive-Behavioral Intervention to Treat Adolescent Binge Eating
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Binge Eating
Eating Disorders in Adolescence
Overweight and Obesity
Keywords: adolescent
cognitive-behavioral therapy
loss of control eating
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-09-12
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will develop and test a cognitive-behavioral intervention for adolescents with binge/loss-of-control eating.

Detailed description: Youth who engage in binge eating or loss-of-control eating are at high risk for physical and mental health impairment, as well as excess weight gain. As there are few evidence-based treatments for adolescents with binge/loss-of-control eating, assessment and treatment have received minimal attention for adolescent patients. Among adults, cognitive-behavioral therapy (CBT) has a strong evidence base for binge-eating disorder. Adolescents have unique social, cognitive and emotional needs because of their developmental stage; unique treatment approaches are essential to meet these unique needs. This study will develop a new CBT treatment for adolescents with binge eating or loss-of-control eating (modifying adult CBT for binge-eating disorder, conducting interviews with adolescents about aspects of treatment that need to be modified, conducting an open series of patients who receive the active treatment). This study will also test the efficacy of the newly-developed CBT for adolescents with binge/loss-of-control eating versus a control group in a randomized controlled trial.

Eligibility criteria: 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. Be available for participation in the study for 7 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.

Primary outcomes:
measure: Binge (Loss-of-control) Eating Episode Frequency
timeFrame: Post (4 months)
measure: Weight (e.g., Percent Loss)
timeFrame: Post (4 months)
Secondary outcomes:
measure: Binge (Loss-of-control) Eating Episode Frequency
timeFrame: Short-Term Follow-Up (3 months after end of treatment)
measure: Weight (e.g., Percent Loss)
timeFrame: Short-Term Follow-Up (3 months after end of treatment)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
Study officials:
References: