Cognitive and Behavioral Approaches to Reduce Binge Eating and Excess Weight in Adolescents (Online)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-17
SponsorIndiana University
About this trial
This study will compare a psychological treatment (cognitive-behavioral therapy; CBT-BED) and a lifestyle beahvioral obesity intervention (LBOI) for adolescents who experience binge eating and have overweight or obesity. These treatments will be compared to each other and to a control condition that involves self-monitoring eating and mood using an "app". Participants can be located in most states in the United States. All participation occurs remotely by telehealth. The goal is to learn which approach works best for reducing binge eating and excess weight in this age group.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 4 episodes of binge eating (feeling a loss of control while eating) per month for the past 3 months;
Be available for participation in the study for 18 months.
Disqualifiers
Have a medical or psychiatric condition that would require a higher level of care, such as hospitalization or intensive outpatient care (e.g., neurological disorder, psychotic disorders, suicidality);
Have a medical or psychiatric condition that would prohibit them from engaging in behavioral treatment or moderate physical activity (e.g., cardiovascular problems);
Have uncontrolled medical condition(s) (e.g., uncontrolled diabetes or hypertension);
Be pregnant or breastfeeding;
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive-Behavioral Therapy for Adolescent Binge Eating
BehavioralCognitive-behavioral therapy for binge-eating disorder (CBT-BED) for adolescents with binge eating and overweight or obesity, delivered remotely by telehealth. Sessions target cognitive and emotional drivers of binge eating through coping skills, problem-solving triggers, cognitive restructuring, and executive-function skill training; parent sessions focus on communication and support.
Lifestyle Behavioral Obesity Intervention
BehavioralLifestyle behavioral obesity intervention (LBOI) for adolescents with binge eating and overweight or obesity, delivered remotely by telehealth. Sessions provide nutrition and physical-activity prescriptions to create a modest calorie deficit and sustainable lifestyle habits and problem-solve nonadherence; parent sessions focus on the home food environment.
Active Control
Other interventionSelf-monitoring eating, emotions, and exercise daily in a digital "app" that is similar to real-world self-help.
Treatment groups
159 Participants
are divided into 3 treatment groupsGroup A: Cognitive-Behavioral TherapyExperimental treatment 1 intervention
Group B: Lifestyle Behavioral Obesity InterventionExperimental treatment 1 intervention
Group C: Active ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Binge Eating Episode Frequency
Eating episodes will be assessed by the Eating Disorder Examination
Time frame
End of treatment (6 months)2
Weight (e.g., Percent Loss)
Percent BMI change
Time frame
End of treatment (6 months)Secondary outcomes
1
Eating Disorder Severity
Global eating-disorder psychopathology will be assessed by the Eating Disorder Examination.
Time frame
End of treatment (6 months)2
Weight-related Quality of Life score
Weight-related quality of life will be assessed by questionnaire.
Time frame
End of treatment (6 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Indiana University
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: