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Completed

NCT Number: NCT04088097

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

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

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Key information

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale School of Medicine

New Haven, Connecticut, 06520, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Control condition

Other

Educational and informational materials on adolescent health and nutrition.

Primary outcomes

  1. Binge (Loss-of-control) Eating Episode Frequency

    Time frame: Post (4 months)

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

  2. Weight (e.g., Percent Loss)

    Time frame: Post (4 months)

    Percent BMI change

Secondary outcomes

  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 questionnaire (Eating Disorder Examination Questionnaire)

  2. Weight (e.g., Percent Loss)

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

    Percent BMI change

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Sep 12, 2019
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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