Binge EatingNCT04088097

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

A study of Binge Eating and Eating Disorders in Adolescence, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 12 to 17 years
Conditions the study is for: Binge Eating, Eating Disorders in Adolescence, Overweight and Obesity
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteUnited States
Study dates: 30 Dec 2019to 8 Jan 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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;
Be available for participation in the study for 7 months.

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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.

United States1 site

Yale School of Medicine
New Haven, Connecticut, 06520

Other trials in United States

About this study

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

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

Read the detailed description

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.

Conditions: Binge Eating, Eating Disorders in Adolescence, Overweight and Obesity
Being tested: Cognitive-Behavioral Therapy for Adolescent Binge/Loss-of-Control Eating, Control Condition
Keywords: adolescent, cognitive-behavioral therapy, loss of control eating
Medical subject headings: Bulimia, Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cognitive-Behavioral Therapy for Adolescent Binge/Loss-of-Control EatingBehavioural
Cognitive-behavioral therapy (CBT) developed for adolescents with binge eating or loss-of-control eating.
Control ConditionOther
Educational and informational materials on adolescent health and nutrition.

Study groups in NCT04088097
Study group	Role	What they receive
Cognitive-Behavioral Therapy	Experimental	Adapted Cognitive-Behavioral Therapy (CBT) for adolescents with binge eating or loss-of-control eating. Receives: Behavioral: Cognitive-Behavioral Therapy for Adolescent Binge/Loss-of-Control Eating
Control Condition	Other	Educational materials related to adolescent health and nutrition. Receives: Other: Control Condition

What is being measured

The primary outcome is the main question the study is designed to answer.

Binge (Loss-of-control) Eating Episode Frequency
Eating episodes will be assessed by questionnaire (Eating Disorder Examination questionnaire)
Measured: Post (4 months)
Weight (e.g., Percent Loss)
Percent BMI change
Measured: Post (4 months)

Secondary outcomes (2)

Binge (Loss-of-control) Eating Episode Frequency
Eating episodes will be assessed by questionnaire (Eating Disorder Examination Questionnaire)
Measured: Short-Term Follow-Up (3 months after end of treatment)
Weight (e.g., Percent Loss)
Percent BMI change
Measured: Short-Term Follow-Up (3 months after end of treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Dec 20198 Jan 2024

First posted12 Sep 2019
Study start30 Dec 2019
Primary completion17 Oct 2023
Study completion8 Jan 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04088097
Sponsor's protocol ID: 2000024926
Other IDs: K23DK115893
Status last verified: Sep 2024
First submitted: 11 Sep 2019
Last updated: 10 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Sleep and Activity For Eating Disorders
Eating Disorders, Anorexia Nervosa
Not yet recruiting
Be Body Brave: Digital Written Exposure Therapy for Eating Disorders
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Active, not recruiting
Project VIBE: Virtual Intervention for Binge Eating in Adolescents
Obesity, Binge-Eating Disorder
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Not yet recruiting
FUS Neuromodulation for Binge Eating Disorder
Binge-Eating Disorder

All Binge Eating trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Development and Initial Efficacy Testing of a Cognitive-Behavioral Intervention to Treat Adolescent Binge Eating
ClinicalTrials.gov ID: NCT04088097
Acronym / sponsor ID: 2000024926
Conditions: Binge Eating, Eating Disorders in Adolescence, Overweight and Obesity
Keywords: adolescent, cognitive-behavioral therapy, loss of control eating
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: 30 Dec 2019 (actual)
Primary completion: 17 Oct 2023 (actual)
Study completion: 8 Jan 2024 (actual)
First posted: 12 Sep 2019 (actual)
Results: Posted 10 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Cognitive-Behavioral Therapy	Experimental	Behavioral: Cognitive-Behavioral Therapy for Adolescent Binge/Loss-of-Control EatingAdapted Cognitive-Behavioral Therapy (CBT) for adolescents with binge eating or loss-of-control eating.
Control Condition	Other	Other: Control ConditionEducational materials related to adolescent health and nutrition.

Who may qualify

Ages: 12 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (16 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
Cognitive-Behavioral Therapy for Adolescent Binge/Loss-of-Control EatingCognitive-behavioral therapy (CBT) developed for adolescents with binge eating or loss-of-control eating.	Behavioural	Cognitive-Behavioral Therapy
Control ConditionEducational and informational materials on adolescent health and nutrition.	Other	Control Condition

Primary outcome

Binge (Loss-of-control) Eating Episode Frequency
Time frame: Post (4 months)
Eating episodes will be assessed by questionnaire (Eating Disorder Examination questionnaire)
Weight (e.g., Percent Loss)
Time frame: Post (4 months)
Percent BMI change

2 secondary outcomes

Binge (Loss-of-control) Eating Episode Frequency
Time frame: Short-Term Follow-Up (3 months after end of treatment)
Weight (e.g., Percent Loss)
Time frame: Short-Term Follow-Up (3 months after end of treatment)

Results and safety

Results posted to the registry on 10 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cognitive-Behavioral Therapy	25	23
Control Condition	25	21

Primary outcome: Binge (Loss-of-control) Eating Episode Frequency

Time frame: Post (4 months). Mean (Standard Deviation). Unit: episodes of behavior

Measure	Cognitive-Behavioral Therapy n = 21	Control Condition n = 19
Value	1.52 (2.09)	6.05 (10.35)

Cognitive-Behavioral Therapy vs Control Condition: p = .01, ANOVA

Primary outcome: Weight (e.g., Percent Loss)

Time frame: Post (4 months). Mean (Standard Deviation). Unit: percentage of baseline BMI

Measure	Cognitive-Behavioral Therapy n = 21	Control Condition n = 20
Value	.02 (.13)	.01 (.06)

Cognitive-Behavioral Therapy vs Control Condition: p = .75, ANOVA

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 7 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cognitive-Behavioral Therapy	0 of 25 (0%)	0 of 25 (0%)	0 of 25
Control Condition	0 of 25 (0%)	0 of 25 (0%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Binge Eating

Enrolling by invitation
Sleep and Activity For Eating Disorders
Eating Disorders, Anorexia Nervosa
Not yet recruiting
Be Body Brave: Digital Written Exposure Therapy for Eating Disorders
Eating Disorders
Active, not recruiting
Project VIBE: Virtual Intervention for Binge Eating in Adolescents
Obesity, Binge-Eating Disorder
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Not yet recruiting
FUS Neuromodulation for Binge Eating Disorder
Binge-Eating Disorder

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study of Binge Eating and Eating Disorders in Adolescence, 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 16 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 10 Oct 2024. 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?

Yes. Results are posted in the registry (first posted 10 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Binge (Loss-of-control) Eating Episode Frequency (time frame: Post (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?

On the ClinicalTrials.gov record for NCT04088097.

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 10 Oct 2024; AzTrials last refreshed its copy on 6 Nov 2026.