Binge Eating Self-help for Teens ONLINE Pilot and Feasibility Study

Overweight or Obesity Clinical Trial

— BEST  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06107387
• Other study ID #: 2000033103
• Secondary ID: 000
• Status: Recruiting
• Phase: N/A
• Start date: February 14, 2024
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Yale University
• Contact: Janet A Lydecker, PhD
• Phone: 12037374299
• Email: janet.lydecker[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Binge Eating
• Binge-Eating Disorder
• Bulimia
• Feeding and Eating Disorders
• Overweight
• Overweight or Obesity

Intervention

Behavioral:
• Binge Eating Self-help for Teens
Guided self-help intervention

Locations

Country	Name	City	State
United States	Yale	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

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