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

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04088097
• Other study ID #: 2000024926
• Secondary ID: K23DK115893
• Status: Completed
• Phase: N/A
• Start date: December 30, 2019
• Est. completion date: January 8, 2024

Study information

• Verified date: February 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: January 8, 2024
• Est. primary completion date: September 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Binge Eating
• Binge-Eating Disorder
• Bulimia
• Eating Disorders in Adolescence
• Feeding and Eating Disorders
• Overweight
• Overweight and Obesity

Intervention

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 and informational materials on adolescent health and nutrition.

Locations

Country	Name	City	State
United States	Yale School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binge (loss-of-control) eating episode frequency	Eating episodes will be assessed by interview	Post (4 months)
Primary	Weight (e.g., percent loss)	BMI z-score (age and sex-based norms)	Post (4 months)
Secondary	Binge (loss-of-control) eating episode frequency	Eating episodes will be assessed by interview	Short-Term Follow-Up (3 months after end of treatment)
Secondary	Weight (e.g., percent loss)	BMI z-score (age and sex-based norms)	Short-Term Follow-Up (3 months after end of treatment)