Overweight or Obesity Clinical Trial
— BESTOfficial title:
Binge Eating Self-help for Teens (BEST): A Pilot and Feasibility Test of an Online Behavioral Intervention for Adolescents With Binge Eating and Elevated Weight
This study is a pilot clinical trial of a new guided self-help CBT for binge eating. Participants will complete an intake assessment; following determination of eligibility, participants will then complete four months of treatment (weekly guided self-help sessions). At the end of treatment, participants will complete an interview with a research clinician to assess outcomes.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 2025 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 17 Years |
Eligibility | Inclusion Criteria: To be included, adolescents must: 1. Be in the age range =12 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. Provide a signed and dated written assent prior to study participation; 7. Provide a signed and dated written consent from one parent prior to study participant; and 8. Be available for participation in the study for 4 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. |
Country | Name | City | State |
---|---|---|---|
United States | Yale | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Attendance | Number of participants attending >75% of sessions | 4 months | |
Primary | Retention | Number of participants who attend through the end of treatment | 4 months | |
Secondary | Treatment Credibility | Adolescent/parent treatment credibility (moderate or higher, study-specific face-valid treatment credibility form) | 1 week | |
Secondary | Treatment Satisfaction | Adolescent/parent/clinician treatment satisfaction (acceptable or higher, Client Satisfaction Questionnaire) | 4 months |
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