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

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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

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

Condition or disease Intervention/treatment Phase
Binge Eating Eating Disorders in Adolescence Overweight and Obesity Behavioral: Cognitive-Behavioral Therapy for Adolescent Binge/Loss-of-Control Eating Other: Control Condition Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Development and Initial Efficacy Testing of a Cognitive-Behavioral Intervention to Treat Adolescent Binge Eating
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : April 30, 2024
Estimated Study Completion Date : April 30, 2024

Arm Intervention/treatment
Experimental: Cognitive-Behavioral Therapy
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
Cognitive-behavioral therapy (CBT) developed for adolescents with binge eating or loss-of-control eating.

Control Condition
Educational materials related to adolescent health and nutrition.
Other: Control Condition
Educational and informational materials on adolescent health and nutrition.




Primary Outcome Measures :
  1. Binge (loss-of-control) eating episode frequency [ Time Frame: Post (4 months) ]
    Eating episodes will be assessed by interview

  2. Weight (e.g., percent loss) [ Time Frame: Post (4 months) ]
    BMI z-score (age and sex-based norms)


Secondary Outcome Measures :
  1. 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

  2. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04088097


Contacts
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Contact: Janet A Lydecker, PhD 12037374299 janet.lydecker@yale.edu

Locations
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United States, Connecticut
Yale School of Medicine Recruiting
New Haven, Connecticut, United States, 06520
Contact: Janet A Lydecker    203-737-4299    janet.lydecker@yale.edu   
Sponsors and Collaborators
Yale University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT04088097     History of Changes
Other Study ID Numbers: 2000024926
K23DK115893 ( U.S. NIH Grant/Contract )
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yale University:
adolescent
cognitive-behavioral therapy
loss of control eating
Additional relevant MeSH terms:
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Overweight
Bulimia
Feeding and Eating Disorders
Binge-Eating Disorder
Body Weight
Signs and Symptoms
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive