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

NCT04088097 | Completed Results

• 2 other identifiers: 2000024926K23DK115893
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Binge Eating; Eating Disorders in Adolescence; Overweight and Obesity

Keywords

adolescent; cognitive-behavioral therapy; loss of control eating

Outcome Measures

Primary Outcomes (2)

• Binge (Loss-of-control) Eating Episode Frequency

  Eating episodes will be assessed by questionnaire (Eating Disorder Examination questionnaire)

  Post (4 months)

• Weight (e.g., Percent Loss)

  Percent BMI change

  Post (4 months)

Secondary Outcomes (2)

• Binge (Loss-of-control) Eating Episode Frequency

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

• Weight (e.g., Percent Loss)

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

Study Arms (2)

Cognitive-Behavioral Therapy

EXPERIMENTAL

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

Control Condition

OTHER

Educational materials related to adolescent health and nutrition.

Other: Control Condition

Interventions

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

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

Cognitive-Behavioral Therapy

Control Condition OTHER

Educational and informational materials on adolescent health and nutrition.

Control Condition

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Bulimia; Overweight; Obesity

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr Janet Lydecker
• Organization: Yale University

janet.lydecker@yale.edu

2037374299

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: September 12, 2019
• Study Start: December 30, 2019
• Primary Completion: October 17, 2023
• Study Completion: January 8, 2024
• Last Updated: October 10, 2024
• Results First Posted: October 10, 2024

Record last verified: 2024-09

Locations

US (1)