- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04088097
Cognitive Behavioral Therapy for Adolescent Binge Eating and Loss of Control Eating
February 13, 2024 updated by: Yale University
Development and Initial Efficacy Testing of a Cognitive-Behavioral Intervention to Treat Adolescent Binge Eating
This study will develop and test a cognitive-behavioral intervention for adolescents with binge/loss-of-control eating.
Study Overview
Status
Completed
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 Type
Interventional
Enrollment (Actual)
55
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Janet A Lydecker, PhD
- Phone Number: 12037374299
- Email: janet.lydecker@yale.edu
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06520
- Yale School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 17 years (Child)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cognitive-Behavioral Therapy
Adapted Cognitive-Behavioral Therapy (CBT) for adolescents with binge eating or 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.
|
Educational and informational materials on adolescent health and nutrition.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Binge (loss-of-control) eating episode frequency
Time Frame: Post (4 months)
|
Eating episodes will be assessed by interview
|
Post (4 months)
|
Weight (e.g., percent loss)
Time Frame: Post (4 months)
|
BMI z-score (age and sex-based norms)
|
Post (4 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Binge (loss-of-control) eating episode frequency
Time Frame: Short-Term Follow-Up (3 months after end of treatment)
|
Eating episodes will be assessed by interview
|
Short-Term Follow-Up (3 months after end of treatment)
|
Weight (e.g., percent loss)
Time Frame: Short-Term Follow-Up (3 months after end of treatment)
|
BMI z-score (age and sex-based norms)
|
Short-Term Follow-Up (3 months after end of treatment)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 30, 2019
Primary Completion (Actual)
September 21, 2023
Study Completion (Actual)
January 8, 2024
Study Registration Dates
First Submitted
September 11, 2019
First Submitted That Met QC Criteria
September 11, 2019
First Posted (Actual)
September 12, 2019
Study Record Updates
Last Update Posted (Actual)
February 16, 2024
Last Update Submitted That Met QC Criteria
February 13, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2000024926
- K23DK115893 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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