Binge-Eating DisorderCHARGENCT03678766
CHARGE: Controlling Hunger and ReGulating Eating
A study testing Regulation of Cues (ROC) and Cognitive Behavior Therapy (CBT) in people with Binge-Eating Disorder and Overweight, run by University of California, San Diego at 1 site in United States.
Trial summary
The objectives of this proposed study are: 1) to evaluate feasibility and acceptability of a novel intervention, Regulation of Cues (ROC), and Cognitive Behavior Therapy (CBT), and 2) to evaluate the efficacy of both treatments on reduction of binge eating and weight loss among 120 Veterans with subclinical or… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Binge-Eating Disorder, Overweight, Obesity
- What is being tested?
- Regulation of Cues (ROC) and Cognitive Behavior Therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2018to 30 Apr 2023
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All participants will be Veterans between the ages of 18-65 meeting criteria for overweight, with a 45≥ BMI ≥25.
- Participants will meet Diagnostic and Statistical Manual-5 (DSM-5) criteria for BED or subclinical BED
- Participants will be willing and able to participate in assessment visits and treatment sessions at University of California, San Diego (UCSD).
- Participants will be able to provide data in English through interviews and questionnaires and understand treatment materials in English.
- Participants will be willing to maintain contact with the investigators for 11 months.
- Participants will be free of serious or unstable medical (current symptoms of angina, stroke, heart disease or other serious medical condition that would make physical activity unsafe or impossible at a moderate level) or psychiatric illness (i.e., active suicidal ideation, history of suicide attempt within 1 year, current unmanaged psychosis, manic episode, anorexia nervosa, bulimia nervosa, or substance abuse within the past year) or psychosocial instability (e.g., homelessness) that could compromise study participation.
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- Participants will be free from conditions in which exercise or weight loss will be detrimental to the participant's health (e.g., pregnancy); pharmacotherapy for obesity or binge eating disorder (e.g., Orlistat or Meridia) or bariatric surgery within the past 6 months or planning to start such treatments in the next 11 months.
- Participants will not be moving out of the San Diego area for the duration of their study enrollment (11 months).
- Participants will not be pregnant, planning to get pregnant in the 11-month study period or lactating.
- Participants will not be participating in group or individual psychotherapy for binge eating or weight management.
- Participants with medical or psychological problems or taking medications that could make adherence with the study protocol difficult or dangerous will not be included.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSD Center for Healthy Eating and Activity Research (CHEAR)
La Jolla, California, 92093
About this study
Official title: Targeting Food Cue Reactivity and Satiety Sensitivity to Decrease Binge Eating and Weight
The objectives of this proposed study are: 1) to evaluate feasibility and acceptability of a novel intervention, Regulation of Cues (ROC), and Cognitive Behavior Therapy (CBT), and 2) to evaluate the efficacy of both treatments on reduction of binge eating and weight loss among 120 Veterans with subclinical or clinical Binge Eating Disorder (BED) with comorbid overweight/obesity (OW/OB).
Read the detailed description
The investigators have developed a new model for the treatment of obesity, called Regulation of Cues (ROC), which is based on Schachter's Externality Theory. This study will compare ROC with Cognitive Behavior Therapy for individuals with Binge Eating Disorder. The investigators will recruit and randomize 120 male and female Veterans with BED and subclinical BED with comorbid overweight/obesity, provide 5 months of treatment and follow participants for 6-months post-treatment. Participants will complete assessments at baseline, mid-treatment (week 9), post-treatment (week 20), and 6-month follow-up (week 44). This study will be the first to contribute to a body of literature developing treatments for BED and overweight/obesity in the Veterans Affairs (VA) and/or military health care systems.
- Conditions
- Binge-Eating Disorder, Overweight, Obesity
- Being tested
- Regulation of Cues (ROC), Cognitive Behavior Therapy (CBT)
- Keywords
- Overweight, Obesity, Binge Eating, Overeating, Body Mass Index, Weight, Treatment, Intervention, Behavioral Treatment
- Medical subject headings
- Binge-Eating Disorder, Overweight, Obesity, Bulimia, Hyperphagia, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regulation of Cues (ROC)Behavioural
Also called ROC
Participants are provided information about basic learning theory and how physiological responses to food cues develop and can be managed. Lack of sensitivity to appetite and satiety cues and increased sensitivity to food cues will be discussed. Coping skills are presented to assist in mastery and toleration of food cue sensitivity. Participants will complete experiential learning exercises with food, and taught to monitor their hunger, satiety, and cravings. The physical activity program will focus on increasing both lifestyle activity and structured exercise programs.
Cognitive Behavior Therapy (CBT)Behavioural
Also called CBT
Participants are taught to identify problems in eating, thinking, and mood patterns that served to trigger binge episodes through self-monitoring and to gradually develop alternative patterns aimed at facilitating healthy, binge-free eating patterns. Participants are taught to eat a healthy variety of foods and reducing the avoidance of "forbidden" foods that are typically consumed during a binge.
| Study group | Role | What they receive |
|---|---|---|
| Regulation of Cues (ROC) | Experimental | The ROC program provides psychoeducation, coping skills, self-monitoring and experimental learning. Receives: Behavioral: Regulation of Cues (ROC) |
| Cognitive Behavior Therapy (CBT) | Experimental | CBT provides coping skills, self-monitoring, and goal setting. Receives: Behavioral: Cognitive Behavior Therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attendance
The number of treatment visits attended
Measured: Post-Treatment (5 months following baseline)
Acceptability
Average likert ratings to questions, such as "How much did you enjoy the treatment?" and "How helpful did you find the treatment?"
Measured: Post-Treatment (5 months following baseline)
Binge Eating as measured by the Eating Disorder Examination (EDE)
Diagnosis of Binge Eating Disorder (BED) and subclinical BED, number of OBEs (large amount of food and loss of control), objective overeating episodes (large amount of food without loss of control), and SBEs (lack of large amount of food with loss of control) determined by responses to the EDE.
Measured: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
Binge Eating as measured by the Binge Eating Scale (BES)
Dimensional score of binge eating consisting of items to describe binge eating behaviors and feelings and cognitions associated with binge eating.
Measured: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
Binge Eating as measured by the Eating Disorder Examination-Questionnaire (EDE-Q)
Three question items from the questionnaire to calculate the number of binge eating episodes and number of days participants experienced a binge eating episode.
Measured: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
Body Mass Index (BMI) as measured by weight and height
Measured: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
Energy intake
Calorie intake estimated by 24-hour dietary recalls on 3 non-consecutive days
Measured: Changes from baseline at an average of 20 weeks and 44 weeks
Secondary outcomes (3)
Satiety Responsiveness
Self-reported satiety responsiveness measured by the Adult Eating Behavior Questionnaire (AEBQ)
Measured: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
Food Responsiveness
Self-reported food responsiveness measured by the Adult Eating Behavior Questionnaire (AEBQ)
Measured: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
Reward-Based Eating
Scales to evaluate reward-related eating measured by the Reward-Based Eating Drive Scale (RED-13)
Measured: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study start30 Sep 2018
- Primary completion30 Mar 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Binge-Eating DisorderStudies of the same condition, open and under way.
- 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
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- San Diego Veterans Healthcare System, United States Department of Defense
- Responsible party
- Principal investigator, Kerri Boutelle, University of California, San Diego
- Investigators
- Kerri Boutelle, Ph.D, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03678766
- Sponsor's protocol ID
- 181015
- Acronym
- CHARGE
- Status last verified
- May 2023
- First submitted
- 18 Sep 2018
- Last updated
- 12 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Boutelle KN, Zucker NL, Peterson CB, Rydell SA, Cafri G, Harnack L. Two novel treatments to reduce overeating in overweight children: a randomized controlled trial. J Consult Clin Psychol. 2011 Dec;79(6):759-71. doi: 10.1037/a0025713.
PubMed 22122291Boutelle KN, Zucker N, Peterson CB, Rydell S, Carlson J, Harnack LJ. An intervention based on Schachter's externality theory for overweight children: the regulation of cues pilot. J Pediatr Psychol. 2014 May;39(4):405-17. doi: 10.1093/jpepsy/jst142. Epub 2014 Jan 23.
PubMed 24459240Boutelle KN, Afari N, Obayashi S, Eichen DM, Strong DR, Pasquale EK, Peterson CB. Regulation of Cues vs Cognitive Behavioral Therapy for Binge Eating and Weight Loss Among Veterans: A Feasibility and Randomized Clinical Trial. JAMA Netw Open. 2025 Aug 1;8(8):e2525064. doi: 10.1001/jamanetworkopen.2025.25064.
PubMed 40758351Boutelle KN, Afari N, Obayashi S, Eichen DM, Strong DR, Peterson CB. Design of the CHARGE study: A randomized control trial evaluating a novel treatment for Veterans with binge eating disorder and overweight and obesity. Contemp Clin Trials. 2023 Jul;130:107234. doi: 10.1016/j.cct.2023.107234. Epub 2023 May 19.
PubMed 37210072
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Food Cue Reactivity and Satiety Sensitivity to Decrease Binge Eating and Weight
- ClinicalTrials.gov ID
- NCT03678766
- Acronym / sponsor ID
- CHARGE / 181015
- Conditions
- Binge-Eating Disorder, Overweight, Obesity
- Keywords
- Overweight, Obesity, Binge Eating, Overeating, Body Mass Index, Weight, Treatment, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- San Diego Veterans Healthcare System, United States Department of Defense
- Study start
- 30 Sep 2018 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 20 Sep 2018 (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.
The objectives of this proposed study are: 1) to evaluate feasibility and acceptability of a novel intervention, Regulation of Cues (ROC), and Cognitive Behavior Therapy (CBT), and 2) to evaluate the efficacy of both treatments on reduction of binge eating and weight loss among 120 Veterans with subclinical or clinical Binge Eating Disorder (BED) with comorbid overweight/obesity (OW/OB).
Detailed description
The investigators have developed a new model for the treatment of obesity, called Regulation of Cues (ROC), which is based on Schachter's Externality Theory. This study will compare ROC with Cognitive Behavior Therapy for individuals with Binge Eating Disorder. The investigators will recruit and randomize 120 male and female Veterans with BED and subclinical BED with comorbid overweight/obesity, provide 5 months of treatment and follow participants for 6-months post-treatment. Participants will complete assessments at baseline, mid-treatment (week 9), post-treatment (week 20), and 6-month follow-up (week 44). This study will be the first to contribute to a body of literature developing treatments for BED and overweight/obesity in the Veterans Affairs (VA) and/or military health care systems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regulation of Cues (ROC) | Experimental | Behavioral: Regulation of Cues (ROC)The ROC program provides psychoeducation, coping skills, self-monitoring and experimental learning. |
| Cognitive Behavior Therapy (CBT) | Experimental | Behavioral: Cognitive Behavior Therapy (CBT)CBT provides coping skills, self-monitoring, and goal setting. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- All participants will be Veterans between the ages of 18-65 meeting criteria for overweight, with a 45≥ BMI ≥25.
- Participants will meet Diagnostic and Statistical Manual-5 (DSM-5) criteria for BED or subclinical BED
- Participants will be willing and able to participate in assessment visits and treatment sessions at University of California, San Diego (UCSD).
- Participants will be able to provide data in English through interviews and questionnaires and understand treatment materials in English.
- Participants will be willing to maintain contact with the investigators for 11 months.
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 |
|---|---|---|
| Regulation of Cues (ROC)Also: ROCParticipants are provided information about basic learning theory and how physiological responses to food cues develop and can be managed. Lack of sensitivity to appetite and satiety cues and increased sensitivity to food cues will be discussed. Coping skills are presented to assist in mastery and toleration of food cue sensitivity. Participants will complete experiential learning exercises with food, and taught to monitor their hunger, satiety, and cravings. The physical activity program will focus on increasing both lifestyle activity and structured exercise programs. | Behavioural | Regulation of Cues (ROC) |
| Cognitive Behavior Therapy (CBT)Also: CBTParticipants are taught to identify problems in eating, thinking, and mood patterns that served to trigger binge episodes through self-monitoring and to gradually develop alternative patterns aimed at facilitating healthy, binge-free eating patterns. Participants are taught to eat a healthy variety of foods and reducing the avoidance of "forbidden" foods that are typically consumed during a binge. | Behavioural | Cognitive Behavior Therapy (CBT) |
Primary outcome
Attendance
Time frame: Post-Treatment (5 months following baseline)
The number of treatment visits attended
Acceptability
Time frame: Post-Treatment (5 months following baseline)
Average likert ratings to questions, such as "How much did you enjoy the treatment?" and "How helpful did you find the treatment?"
Binge Eating as measured by the Eating Disorder Examination (EDE)
Time frame: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
Diagnosis of Binge Eating Disorder (BED) and subclinical BED, number of OBEs (large amount of food and loss of control), objective overeating episodes (large amount of food without loss of control), and SBEs (lack of large amount of food with loss of control) determined by responses to the EDE.
Binge Eating as measured by the Binge Eating Scale (BES)
Time frame: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
Dimensional score of binge eating consisting of items to describe binge eating behaviors and feelings and cognitions associated with binge eating.
Binge Eating as measured by the Eating Disorder Examination-Questionnaire (EDE-Q)
Time frame: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
Three question items from the questionnaire to calculate the number of binge eating episodes and number of days participants experienced a binge eating episode.
Body Mass Index (BMI) as measured by weight and height
Time frame: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
Energy intake
Time frame: Changes from baseline at an average of 20 weeks and 44 weeks
Calorie intake estimated by 24-hour dietary recalls on 3 non-consecutive days
3 secondary outcomes
Satiety Responsiveness
Time frame: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
Food Responsiveness
Time frame: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
Reward-Based Eating
Time frame: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
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 12 May 2023.
- Background: PubMed 22122291Boutelle KN, Zucker NL, Peterson CB, Rydell SA, Cafri G, Harnack L. Two novel treatments to reduce overeating in overweight children: a randomized controlled trial. J Consult Clin Psychol. 2011 Dec;79(6):759-71. doi: 10.1037/a0025713.
- Background: PubMed 24459240Boutelle KN, Zucker N, Peterson CB, Rydell S, Carlson J, Harnack LJ. An intervention based on Schachter's externality theory for overweight children: the regulation of cues pilot. J Pediatr Psychol. 2014 May;39(4):405-17. doi: 10.1093/jpepsy/jst142. Epub 2014 Jan 23.
- Derived from this study: PubMed 40758351Boutelle KN, Afari N, Obayashi S, Eichen DM, Strong DR, Pasquale EK, Peterson CB. Regulation of Cues vs Cognitive Behavioral Therapy for Binge Eating and Weight Loss Among Veterans: A Feasibility and Randomized Clinical Trial. JAMA Netw Open. 2025 Aug 1;8(8):e2525064. doi: 10.1001/jamanetworkopen.2025.25064.
- Derived from this study: PubMed 37210072Boutelle KN, Afari N, Obayashi S, Eichen DM, Strong DR, Peterson CB. Design of the CHARGE study: A randomized control trial evaluating a novel treatment for Veterans with binge eating disorder and overweight and obesity. Contemp Clin Trials. 2023 Jul;130:107234. doi: 10.1016/j.cct.2023.107234. Epub 2023 May 19.
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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.
Kerri Boutelle, Ph.D principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regulation of Cues (ROC) and Cognitive Behavior Therapy (CBT) in people with Binge-Eating Disorder and Overweight, run by University of California, San Diego 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 11 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 12 May 2023. 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: Post-Treatment (5 months following baseline)). The study lists 7 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 NCT03678766, which also lists 4 linked publications.
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 12 May 2023.