Binge EatingCARE2NCT07856784
Cognitive and Behavioral Approaches to Reduce Binge Eating and Excess Weight in Adolescents (Online)
A study testing Cognitive-Behavioral Therapy for Adolescent Binge Eating and Lifestyle Behavioral Obesity Intervention in people with Binge Eating and Overweight and Obesity, run by Indiana University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Binge Eating, Overweight and Obesity, Eating Disorders in Adolescence
- What is being tested?
- Cognitive-Behavioral Therapy for Adolescent Binge Eating and Lifestyle Behavioral Obesity Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 31 Jan 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 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.
Who cannot join
- 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;
- Be taking medication(s) or participating in treatment(s) that could influence weight or appetite;
- Have begun taking hormonal contraceptives less than 3 months prior, as this can be related to weight changes;
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- Have a developmental or cognitive disorder that would interfere with engaging in cognitive treatment;
- Have a concurrent feeding/eating disorder (e.g., bulimia nervosa); or
- Be participating in another clinical research study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Janet Lydecker, PhD, 317-963-7288, jalydeck@iu.edu
About this study
Official title: Cognitive and Behavioral Approaches to Reduce Binge Eating and Excess Weight in Adolescents (CARE2)
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.
Read the detailed description
Binge eating is the most prevalent eating disorder but has the lowest rate (<4%) of receiving eating disorder treatment. Binge eating often begins in adolescence and is related to obesity, physical and mental health problems, and psychological distress. Yet, there are virtually no established treatments, and no clear standard of care, for adolescents with binge eating. Evidence-based treatments exist for adults, including psychological treatments (e.g., CBT-BED) and lifestyle behavioral obesity intervention (LBOI), but how well these treatments work for adolescents remains largely unknown. LBOI is an effective treatment for adolescent obesity, but has only been tested as additional outcomes (not the initial goal) for binge eating. There is an urgent need for research to establish the efficacy of interventions for adolescents with binge eating to improve adolescents' health and quality of life. This study will conduct a randomized controlled trial (RCT) in which adolescents are randomized to Psychological Treatment (cognitive behavioral therapy for binge eating, or CBT-BED), Behavioral Treatment (lifestyle health behavioral treatment for obesity, or LBOI), or Active Control. In this study, we will compare both CBT-BED and LBOI to each other and to an Active Control. Active Control is daily self-monitoring (emotions, eating, exercise) on an "app", mimicking real-world self-help, followed by choice of CBT-BED or LBOI.
- Being tested
- Cognitive-Behavioral Therapy for Adolescent Binge Eating, Lifestyle Behavioral Obesity Intervention, Active Control
- Keywords
- cognitive-behavioral therapy, obesity, psychotherapy, randomized controlled trial, binge eating, eating disorder, adolescent, child, parent
- Medical subject headings
- Bulimia, Overweight, Obesity, Feeding and Eating Disorders
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 EatingBehavioural
Also called CBT-BED
Cognitive-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 InterventionBehavioural
Also called LBOI, Intensive Health Behavior Lifestyle Treatment, Behavioral Obesity Treatment, Behavioral Weight Loss
Lifestyle 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 ControlOther
Also called Self-monitoring
Self-monitoring eating, emotions, and exercise daily in a digital "app" that is similar to real-world self-help.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-Behavioral Therapy | Experimental | Cognitive-behavioral therapy for binge-eating disorder (CBT-BED) for adolescents with binge eating and overweight or obesity, delivered remotely by telehealth. Receives: Behavioral: Cognitive-Behavioral Therapy for Adolescent Binge Eating |
| Lifestyle Behavioral Obesity Intervention | Experimental | Lifestyle behavioral obesity intervention (LBOI) for adolescents with binge eating and overweight or obesity, delivered remotely by telehealth. Receives: Behavioral: Lifestyle Behavioral Obesity Intervention |
| Active Control | Active comparator | Active control: daily self-monitoring of eating, emotions, and physical activity via an "app," similar to real-world digital self-help. At the end of the initial period, individuals are presented with descriptions of CBT-BED and LBOI, choose their preferred treatment, and receive it. Receives: Other: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binge Eating Episode Frequency
Eating episodes will be assessed by the Eating Disorder Examination
Measured: End of treatment (6 months)
Weight (e.g., Percent Loss)
Percent body mass index change
Measured: End of treatment (6 months)
Secondary outcomes (2)
Eating Disorder Severity
Global eating-disorder psychopathology will be assessed by the Eating Disorder Examination (scores range from 0 through 6; higher scores indicate more severe psychopathology).
Measured: End of treatment (6 months)
Weight-related Quality of Life score
Weight-related quality of life will be assessed by questionnaire.
Measured: End of treatment (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Jan 2030 (estimated)
- Study completion31 Jan 2031 (estimated)
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 Indiana 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
- 159 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janet Lydecker, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07856784
- Sponsor's protocol ID
- 32948
- Other IDs
- R01DK146817
- Acronym
- CARE2
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: de-identified data will be shared with qualified researchers with ethics board approval and a data use agreement.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive and Behavioral Approaches to Reduce Binge Eating and Excess Weight in Adolescents (CARE2)
- ClinicalTrials.gov ID
- NCT07856784
- Acronym / sponsor ID
- CARE2 / 32948
- Keywords
- cognitive-behavioral therapy, obesity, psychotherapy, randomized controlled trial, binge eating, eating disorder, adolescent, child
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 159 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Jan 2030 (estimated)
- Study completion
- 31 Jan 2031 (estimated)
- First posted
- 5 Oct 2026 (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 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.
Detailed description
Binge eating is the most prevalent eating disorder but has the lowest rate (<4%) of receiving eating disorder treatment. Binge eating often begins in adolescence and is related to obesity, physical and mental health problems, and psychological distress. Yet, there are virtually no established treatments, and no clear standard of care, for adolescents with binge eating. Evidence-based treatments exist for adults, including psychological treatments (e.g., CBT-BED) and lifestyle behavioral obesity intervention (LBOI), but how well these treatments work for adolescents remains largely unknown. LBOI is an effective treatment for adolescent obesity, but has only been tested as additional outcomes (not the initial goal) for binge eating. There is an urgent need for research to establish the efficacy of interventions for adolescents with binge eating to improve adolescents' health and quality of life. This study will conduct a randomized controlled trial (RCT) in which adolescents are randomized to Psychological Treatment (cognitive behavioral therapy for binge eating, or CBT-BED), Behavioral Treatment (lifestyle health behavioral treatment for obesity, or LBOI), or Active Control. In this study, we will compare both CBT-BED and LBOI to each other and to an Active Control. Active Control is daily self-monitoring (emotions, eating, exercise) on an "app", mimicking real-world self-help, followed by choice of CBT-BED or LBOI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive-Behavioral Therapy | Experimental | Behavioral: Cognitive-Behavioral Therapy for Adolescent Binge EatingCognitive-behavioral therapy for binge-eating disorder (CBT-BED) for adolescents with binge eating and overweight or obesity, delivered remotely by telehealth. |
| Lifestyle Behavioral Obesity Intervention | Experimental | Behavioral: Lifestyle Behavioral Obesity InterventionLifestyle behavioral obesity intervention (LBOI) for adolescents with binge eating and overweight or obesity, delivered remotely by telehealth. |
| Active Control | Active comparator | Other: Active ControlActive control: daily self-monitoring of eating, emotions, and physical activity via an "app," similar to real-world digital self-help. At the end of the initial period, individuals are presented with descriptions of CBT-BED and LBOI, choose their preferred treatment, and receive it. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 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 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.
Key exclusion criteria (9 listed)
- 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;
- Be taking medication(s) or participating in treatment(s) that could influence weight or appetite;
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 EatingAlso: CBT-BEDCognitive-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. | Behavioural | Cognitive-Behavioral Therapy |
| Lifestyle Behavioral Obesity InterventionAlso: LBOI, Intensive Health Behavior Lifestyle Treatment, Behavioral Obesity Treatment, Behavioral Weight LossLifestyle 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. | Behavioural | Lifestyle Behavioral Obesity Intervention |
| Active ControlAlso: Self-monitoringSelf-monitoring eating, emotions, and exercise daily in a digital "app" that is similar to real-world self-help. | Other | Active Control |
Primary outcome
Binge Eating Episode Frequency
Time frame: End of treatment (6 months)
Eating episodes will be assessed by the Eating Disorder Examination
Weight (e.g., Percent Loss)
Time frame: End of treatment (6 months)
Percent body mass index change
2 secondary outcomes
Eating Disorder Severity
Time frame: End of treatment (6 months)
Weight-related Quality of Life score
Time frame: End of treatment (6 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No. de-identified data will be shared with qualified researchers with ethics board approval and a data use agreement.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-Behavioral Therapy for Adolescent Binge Eating and Lifestyle Behavioral Obesity Intervention in people with Binge Eating and Overweight and Obesity, run by Indiana 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 4 inclusion and 9 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: opening soon, as of the sponsor's last update on 29 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binge Eating Episode Frequency (time frame: End of treatment (6 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 29 Oct 2026.