Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04088097
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : September 17, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date  ICMJE September 11, 2019
First Posted Date  ICMJE September 12, 2019
Last Update Posted Date September 17, 2019
Estimated Study Start Date  ICMJE October 1, 2019
Estimated Primary Completion Date April 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2019)
  • Binge (loss-of-control) eating episode frequency [ Time Frame: Post (4 months) ]
    Eating episodes will be assessed by interview
  • Weight (e.g., percent loss) [ Time Frame: Post (4 months) ]
    BMI z-score (age and sex-based norms)
Original Primary Outcome Measures  ICMJE
 (submitted: September 11, 2019)
  • Binge (loss-of-control) eating episode frequency [ Time Frame: Post (4 months) ]
    Eating will be assessed by interview and self-report
  • Weight (e.g., percent loss) [ Time Frame: Post (4 months) ]
    BMI z-score (age and sex-based norms)
Change History Complete list of historical versions of study NCT04088097 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2019)
  • 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
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2019)
  • Binge (loss-of-control) eating episode frequency [ Time Frame: Short-Term Follow-Up (3 months after end of treatment) ]
    Eating will be assessed by interview and self-report
  • 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cognitive Behavioral Therapy for Adolescent Binge Eating and Loss of Control Eating
Official Title  ICMJE Development and Initial Efficacy Testing of a Cognitive-Behavioral Intervention to Treat Adolescent Binge Eating
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Binge Eating
  • Eating Disorders in Adolescence
  • Overweight and Obesity
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Cognitive-Behavioral Therapy
    Adapted Cognitive-Behavioral Therapy (CBT) for adolescents with binge eating or loss-of-control eating.
    Intervention: Behavioral: Cognitive-Behavioral Therapy for Adolescent Binge/Loss-of-Control Eating
  • Control Condition
    Educational materials related to adolescent health and nutrition.
    Intervention: Other: Control Condition
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 11, 2019)
55
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2024
Estimated Primary Completion Date April 30, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria: To be included, adolescents must:

  1. Be in the age range ≥13 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Janet A Lydecker, PhD 12037374299 janet.lydecker@yale.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04088097
Other Study ID Numbers  ICMJE 2000024926
K23DK115893 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE Not Provided
PRS Account Yale University
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP