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

Primary Purpose

Binge Eating, Eating Disorders in Adolescence, Overweight and Obesity

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

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

Control Condition

About this trial

This is an interventional treatment trial for Binge Eating focused on measuring adolescent, cognitive-behavioral therapy, loss of control eating

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept 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.

Sites / Locations

Yale School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Cognitive-Behavioral Therapy

Control Condition

Arm Description

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

Educational materials related to adolescent health and nutrition.

Outcomes

Primary Outcome Measures

Binge (loss-of-control) eating episode frequency

Eating episodes will be assessed by interview

Weight (e.g., percent loss)

BMI z-score (age and sex-based norms)

Secondary Outcome Measures

Binge (loss-of-control) eating episode frequency

Eating episodes will be assessed by interview

Weight (e.g., percent loss)

BMI z-score (age and sex-based norms)

Full Information

NCT ID

NCT04088097

First Posted

September 11, 2019

Last Updated

September 7, 2023

Sponsor

Yale University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04088097

Brief Title

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

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

December 30, 2019 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Binge Eating, Eating Disorders in Adolescence, Overweight and Obesity

Keywords

adolescent, cognitive-behavioral therapy, loss of control eating

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

55 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cognitive-Behavioral Therapy

Arm Type

Experimental

Arm Description

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

Arm Title

Control Condition

Arm Type

Other

Arm Description

Educational materials related to adolescent health and nutrition.

Intervention Type

Behavioral

Intervention Name(s)

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

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Control Condition

Intervention Description

Educational and informational materials on adolescent health and nutrition.

Primary Outcome Measure Information:

Title

Binge (loss-of-control) eating episode frequency

Description

Eating episodes will be assessed by interview

Time Frame

Post (4 months)

Title

Weight (e.g., percent loss)

Description

BMI z-score (age and sex-based norms)

Time Frame

Post (4 months)

Secondary Outcome Measure Information:

Title

Binge (loss-of-control) eating episode frequency

Description

Eating episodes will be assessed by interview

Time Frame

Short-Term Follow-Up (3 months after end of treatment)

Title

Weight (e.g., percent loss)

Description

BMI z-score (age and sex-based norms)

Time Frame

Short-Term Follow-Up (3 months after end of treatment)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Yale School of Medicine

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520

Country

United States

12. IPD Sharing Statement

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

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