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

NCT ID: NCT04088097

Last Updated: 2024-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-30
• Study Completion Date: 2024-01-08

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.

Conditions

Binge Eating; Eating Disorders in Adolescence; Overweight and Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cognitive-Behavioral Therapy

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

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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

Control Condition

Educational materials related to adolescent health and nutrition.

Group Type: OTHER

Control Condition

Intervention Type: OTHER

Educational and informational materials on adolescent health and nutrition.

Interventions

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.

Intervention Type: BEHAVIORAL

Control Condition

Educational and informational materials on adolescent health and nutrition.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Yale School of Medicine

New Haven, Connecticut, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

K23DK115893

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000024926

Identifier Type: -

Identifier Source: org_study_id