Cognitive Behavioral Therapy for Adolescent Binge Eating and Loss of Control Eating

Sponsor

Yale University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04088097

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Binge Eating Eating Disorders in Adolescence Overweight and Obesity	Behavioral: Cognitive-Behavioral Therapy for Adolescent Binge/Loss-of-Control Eating Other: Control Condition	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

55 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Development and Initial Efficacy Testing of a Cognitive-Behavioral Intervention to Treat Adolescent Binge Eating

Actual Study Start Date :

Dec 30, 2019

Anticipated Primary Completion Date :

Apr 30, 2024

Anticipated Study Completion Date :

Apr 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cognitive-Behavioral Therapy Adapted Cognitive-Behavioral Therapy (CBT) for adolescents with binge eating or loss-of-control eating.	Behavioral: Cognitive-Behavioral Therapy for Adolescent Binge/Loss-of-Control Eating Cognitive-behavioral therapy (CBT) developed for adolescents with binge eating or loss-of-control eating.
Other: Control Condition Educational materials related to adolescent health and nutrition.	Other: Control Condition Educational and informational materials on adolescent health and nutrition.

Arm

Intervention/Treatment

Experimental: Cognitive-Behavioral Therapy

Adapted Cognitive-Behavioral Therapy (CBT) for adolescents with binge eating or loss-of-control eating.

Behavioral: Cognitive-Behavioral Therapy for Adolescent Binge/Loss-of-Control Eating

Cognitive-behavioral therapy (CBT) developed for adolescents with binge eating or loss-of-control eating.

Other: Control Condition

Educational materials related to adolescent health and nutrition.

Other: Control Condition

Educational and informational materials on adolescent health and nutrition.

Outcome Measures

Primary Outcome Measures

Binge (loss-of-control) eating episode frequency [Post (4 months)]
Eating episodes will be assessed by interview
Weight (e.g., percent loss) [Post (4 months)]
BMI z-score (age and sex-based norms)

Secondary Outcome Measures

Binge (loss-of-control) eating episode frequency [Short-Term Follow-Up (3 months after end of treatment)]
Eating episodes will be assessed by interview
Weight (e.g., percent loss) [Short-Term Follow-Up (3 months after end of treatment)]
BMI z-score (age and sex-based norms)

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.