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Clinical Trials/NCT04088097
NCT04088097
Completed
Not Applicable

Development and Initial Efficacy Testing of a Cognitive-Behavioral Intervention to Treat Adolescent Binge Eating

Yale University1 site in 1 country50 target enrollmentDecember 30, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Binge Eating
Sponsor
Yale University
Enrollment
50
Locations
1
Primary Endpoint
Binge (Loss-of-control) Eating Episode Frequency
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 30, 2019
End Date
January 8, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Binge (Loss-of-control) Eating Episode Frequency

Time Frame: Post (4 months)

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

Weight (e.g., Percent Loss)

Time Frame: Post (4 months)

Percent BMI change

Secondary Outcomes

  • 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 Sites (1)

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