Binge EatingBESTNCT06107387
Binge Eating Self-help for Teens ONLINE Pilot and Feasibility Study
A study testing Binge Eating Self-help for Teens in people with Binge Eating and Binge-Eating Disorder, run by Yale University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Binge Eating, Binge-Eating Disorder, Overweight or Obesity
- What is being tested?
- Binge Eating Self-help for Teens
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2024to 26 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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;
- Provide a signed and dated written assent prior to study participation;
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- Provide a signed and dated written consent from one parent prior to study participant; and
- Be available for participation in the study for 4 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Binge Eating, Binge-Eating Disorder, Overweight or Obesity
- Being tested
- Binge Eating Self-help for Teens
- Medical subject headings
- Bulimia, Binge-Eating Disorder, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Binge Eating Self-help for TeensBehavioural
Also called BEST
Guided self-help intervention
| Study group | Role | What they receive |
|---|---|---|
| Binge Eating Self-help for Teens | Experimental | Participants will have 16 guided self-help sessions (4 months; weekly sessions for adolescents with parents joining monthly). Participants will complete daily self-monitoring of eating behaviors (timing of meals and snacks; whether or not a binge occurred) throughout treatment. Treatment sessions involve a self-help component, which includes brief videos that participants watch at home. Treatment sessions also involve a guidance component (brief consultation), which is 15-30 minutes on a secure videoconferencing platform (e.g., Zoom) between the therapist and the participant. These sessions focus on clarifying material, reviewing self-monitoring and looking for patterns, and problem-solving maladaptive thinking patterns and binge behaviors. Receives: Behavioral: Binge Eating Self-help for Teens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attendance
Number of participants attending >75% of sessions
Measured: 4 months
Retention
Number of participants who attend through the end of treatment
Measured: 4 months
Secondary outcomes (2)
Treatment Credibility
Adolescent/parent treatment credibility (moderate or higher, study-specific face-valid treatment credibility form)
Measured: 1 week
Treatment Satisfaction
Adolescent/parent/clinician treatment satisfaction (acceptable or higher, Client Satisfaction Questionnaire)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start14 Feb 2024
- Primary completion26 Jun 2025
- Study completion26 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge EatingStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janet A Lydecker, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107387
- Sponsor's protocol ID
- 2000033103
- Other IDs
- 000
- Acronym
- BEST
- Status last verified
- Dec 2025
- First submitted
- 24 Oct 2023
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a pilot study. We are prioritizing individuals' privacy because they are children and binge eating and weight can be stigmatizing. We will consider requests to share individual-level data from other researchers if they are consistent with privacy protections.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06107387
- Acronym / sponsor ID
- BEST / 2000033103
- Conditions
- Binge Eating, Binge-Eating Disorder, Overweight or Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- 26 Jun 2025 (actual)
- Study completion
- 26 Jun 2025 (actual)
- First posted
- 30 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Binge Eating Self-help for Teens | Experimental | Behavioral: Binge Eating Self-help for TeensParticipants will have 16 guided self-help sessions (4 months; weekly sessions for adolescents with parents joining monthly). Participants will complete daily self-monitoring of eating behaviors (timing of meals and snacks; whether or not a binge occurred) throughout treatment. Treatment sessions involve a self-help component, which includes brief videos that participants watch at home. Treatment sessions also involve a guidance component (brief consultation), which is 15-30 minutes on a secure videoconferencing platform (e.g., Zoom) between the therapist and the participant. These sessions focus on clarifying material, reviewing self-monitoring and looking for patterns, and problem-solving maladaptive thinking patterns and binge behaviors. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (18 listed)
- 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;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Binge Eating Self-help for TeensAlso: BESTGuided self-help intervention | Behavioural | Binge Eating Self-help for Teens |
Primary outcome
Attendance
Time frame: 4 months
Number of participants attending >75% of sessions
Retention
Time frame: 4 months
Number of participants who attend through the end of treatment
2 secondary outcomes
Treatment Credibility
Time frame: 1 week
Treatment Satisfaction
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Individual participant dataSharing planned: No. This is a pilot study. We are prioritizing individuals' privacy because they are children and binge eating and weight can be stigmatizing. We will consider requests to share individual-level data from other researchers if they are consistent with privacy protections.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet A Lydecker, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Binge Eating Self-help for Teens in people with Binge Eating and Binge-Eating Disorder, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attendance (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.