Overweight and ObesitySHARENCT05004883
Solutions for Hunger And Regulating Eating
A study testing Regulation of Cues Enhanced, Behavioral Weight Loss and Nutrition Education, Stress Management and Social Support in people with Overweight and Obesity, run by University of California, San Diego at 1 site in United States.
Trial summary
The objective of this proposed study is to collect efficacy data on ROC+ compared to an active comparator (AC) and to Behavioral Weight Loss (BWL) for participants who are high in Food Responsiveness. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Regulation of Cues Enhanced, Behavioral Weight Loss and Nutrition Education, Stress Management and Social Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 293 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 30 Jun 2026
- 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
- high Food Responsiveness
- BMI between 25kg/m^2 and 45kg/m^2
- able to read English at a 5th grade reading level
- willing and able to participate in assessment visits and treatment sessions, whether held in-person or via password protected Zoom meetings
- able to provide data through questionnaires
- has a smart phone through which they can complete Ecological Momentary Assessments
Who cannot join
- major medical conditions such as diabetes or recent history of coronary heart disease; symptoms of angina, stroke, osteoarthritis, osteoporosis, orthopedic problems that would limit activity during the following 18 months; or any other serious medical condition that would make physical activity unsafe
- bulimia or anorexia, significant cognitive impairment, a known psychotic disorder, acute suicidal ideation, moderate or severe alcohol or substance use disorder, or unstable psychiatric illness (e.g., recent psychiatric hospitalization in the past year)
- medical or psychological problems that could make adherence with the study protocol difficult or dangerous
- pregnant, lactating, or planning to become pregnant in the next 18 months
- participating in other weight control programs and/or taking medication for weight loss
- previous bariatric surgery
- moving out of the San Diego area for the duration of their study enrollment (18 months)
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSD Center for Healthy Eating and Activity Research (CHEAR)
La Jolla, California, 92037
About this study
Official title: Targeting Food Cue Responsiveness for Weight Loss
The objective of this proposed study is to collect efficacy data on ROC+ compared to an active comparator (AC) and to Behavioral Weight Loss (BWL) for participants who are high in Food Responsiveness.
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 Behavioral Susceptibility Theory. The ROC program targets two theorized mechanisms for overeating; decreased sensitivity to appetitive cues and increased sensitivity to external food cues. Considering that BWL has merit for some people, but fails to facilitate maintenance, this study will compare BWL, ROC with some aspects of BWL (ROC+) and an active comparator (AC). All treatment groups will be 1.5 hours (including weigh-ins) and will be provided in groups of 15-20 participants weekly for 4 months and twice a month for 2 months (total treatment duration = 6 months, 20 meetings). The investigators will recruit adults with overweight or obesity who are high in Food Responsiveness (FR) and will assess them at baseline, post-treatment (month 6), mid-follow-up (month 12) and follow-up (month 18).
- Conditions
- Overweight and Obesity
- Being tested
- Regulation of Cues Enhanced, Behavioral Weight Loss, Nutrition Education, Stress Management and Social Support
- Keywords
- Food Responsiveness, Satiety Responsiveness, Weight Loss, Overeating
- Medical subject headings
- Overweight, Obesity, Weight Loss, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regulation of Cues EnhancedBehavioural
Also called ROC+
ROC is based on the Behavioral Susceptibility Theory and designed to incorporate psychoeducation, cue-exposure treatment, appetite awareness training, coping skills, and self-monitoring of satiety and cravings to treat high Food Responsiveness and low Satiety Responsiveness. BWL and ROC will be integrated for this arm, to capitalize on the strengths of both treatments. All participants will be taught to decrease caloric intake and increase physical activity, and to use all of the behavioral skills provided in BWL. However, they will also be taught models of hunger and satiety and about food cue reactivity, and will learn skills to manage these. This arm will include an experiential component, including hunger monitoring during dinner and participating in exposure exercises.
Behavioral Weight LossBehavioural
Also called BWL
The BWL program includes dietary, physical activity, and behavioral change recommendations. All participants will be instructed on how to consume a balanced deficit diet of conventional foods; individual goals for energy intake will be based on initial body weight. Participants will be instructed in measuring portion sizes, counting calories, and self-monitoring food intake. The physical activity program will focus on increasing both lifestyle activity and structured exercise programs. Behavior change recommendations include stimulus control, self-monitoring, goal setting, managing high-risk situations, meal planning, slowing eating, problem solving, social support, cognitive restructuring, lapse and relapse prevention skills, and maintaining weight loss.
Nutrition Education, Stress Management and Social SupportBehavioural
Topics included will be stress management/relaxation, social support, and nutrition education. There will be a strong mindfulness component to this group.
| Study group | Role | What they receive |
|---|---|---|
| Regulation of Cues Enhanced Treatment | Experimental | The ROC program provides psychoeducation, coping skills, self-monitoring and experiential learning, and it will be combined with aspects of BWL to capitalize on the strengths of both treatments. Receives: Behavioral: Regulation of Cues Enhanced |
| Behavioral Weight Loss | Active comparator | The BWL program will include dietary recommendations, physical activity recommendations, and behavioral change recommendations. Receives: Behavioral: Behavioral Weight Loss |
| Nutrition, Stress Management, and Social Support | Active comparator | Nutrition Education, Stress Management and Social Support will be covered. Mindfulness will be practiced in every session. Receives: Behavioral: Nutrition Education, Stress Management and Social Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Mass Index
Body Mass Index as measured by height and weight
Measured: Change from baseline at an average of 6 months, 9 months, 12 months, 15 months, and 18 months
Secondary outcomes (6)
Change in Food Responsiveness As Measured by the FR Scale of the AEBQ
The Adult Eating Behavior Questionnaire (AEBQ) assesses appetitive traits, including food responsiveness, hunger, and satiety responsiveness. We will use the food responsiveness (FR) scale to measure participants' food responsiveness at a given time point. The score for the FR scale ranges from 4-20, with higher scores indicating higher food responsiveness, and lower scores indicating lower food responsiveness.
Measured: Change from baseline at an average of 6 months, 12 months, and 18 months
Change in Satiety Responsiveness As Measured by the SR Scale of the AEBQ
The Adult Eating Behavior Questionnaire (AEBQ) assesses appetitive traits, including food responsiveness, hunger, and satiety responsiveness. We will use the satiety responsiveness (SR) scale to measure participants' satiety responsiveness at a given time point. The score for the SR scale ranges from 4-20, with higher scores indicating higher satiety responsiveness, and lower scores indicating lower satiety responsiveness.
Measured: Change from baseline at an average of 6 months, 12 months, and 18 months
Change in Inhibition As Measured by the Stop Signal Task
Go stimuli are four pictures of food in landscape or portrait format; participants must respond to the go stimuli by pressing the left and right response keys on the keyboard. On 25% of trials, a visual stop signal will be presented; participants are instructed to withhold responding when this signal is presented. This task measures inhibitory control.
Measured: Change from baseline at an average of 6 months, 12 months, and 18 months
Change in Restriction As Measured by the TFEQ
The Three-Factor Eating Questionnaire (TFEQ) assesses three cognitive and behavioral domains of eating: cognitive restraint, disinhibition, and hunger. We will use the restraint subscale to measure restriction. Scores on the restraint subscale range from 0-21, with lower scores indicating less restriction and higher scores indicating more restriction.
Measured: Change from baseline at an average of 6 months, 12 months, and 18 months
Change in Caloric Intake As Measured by the DHQ III
The Diet History Questionnaire III consists of 135 food and beverage line items and 26 dietary supplement questions. Some line items for foods and beverages have additional embedded questions that allow for final assignment to items in the nutrient and food group database leading to 263 foods/beverages listed in the database. For example, a single line item asks frequency of intake and portion size of soda or soft drinks. Embedded underneath are questions regarding whether the soft drinks consumed are regular vs. diet or caffeinated vs. decaffeinated. Answers to these questions lead to assignment of one of four food codes in the database: diet soda with caffeine, diet soda without caffeine, regular soda with caffeine or regular soda without caffeine. We will use this to measure caloric intake.
Measured: Change from baseline at an average of 6 months, 12 months, and 18 months
Change in Eating Cognitions As Measured by the FCQ-T-reduced
The shortened version of the Food Craving Questionnaire - Trait (FCQ-T-reduced) assesses food cravings and evaluates food craving traits. We will use it to measure eating cognitions. Item scores range from 1-6, and the overall score ranges from 15-90, with higher scores indicating with more food craving cognitions, and lower scores indicating fewer food craving cognitions.
Measured: Change from baseline at an average of 6 months, 12 months, and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start1 Sep 2021
- Primary completion10 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies 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
- 293 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Kerri Boutelle, University of California, San Diego
- Investigators
- Kerri Boutelle, Ph.D., Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05004883
- Sponsor's protocol ID
- 201362
- Other IDs
- R01DK122504
- Acronym
- SHARE
- Status last verified
- Sep 2026
- First submitted
- 6 Aug 2021
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Boutelle KN, Eichen DM, Obayashi S, Pasquale EK, Strong DR, Tietz AS, Reed KL, Peterson CB. Design of the SHARE study: A randomized controlled trial evaluating the regulation of cues treatment for adults with overweight or obesity and high food responsiveness. Contemp Clin Trials. 2025 Aug;155:107970. doi: 10.1016/j.cct.2025.107970. Epub 2025 Jun 1.
PubMed 40460908
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Food Cue Responsiveness for Weight Loss
- ClinicalTrials.gov ID
- NCT05004883
- Acronym / sponsor ID
- SHARE / 201362
- Conditions
- Overweight and Obesity
- Keywords
- Food Responsiveness, Satiety Responsiveness, Weight Loss, Overeating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 293 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- University of Minnesota, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 10 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 13 Aug 2021 (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 objective of this proposed study is to collect efficacy data on ROC+ compared to an active comparator (AC) and to Behavioral Weight Loss (BWL) for participants who are high in Food Responsiveness.
Detailed description
The investigators have developed a new model for the treatment of obesity, called Regulation of Cues (ROC), which is based on Behavioral Susceptibility Theory. The ROC program targets two theorized mechanisms for overeating; decreased sensitivity to appetitive cues and increased sensitivity to external food cues. Considering that BWL has merit for some people, but fails to facilitate maintenance, this study will compare BWL, ROC with some aspects of BWL (ROC+) and an active comparator (AC). All treatment groups will be 1.5 hours (including weigh-ins) and will be provided in groups of 15-20 participants weekly for 4 months and twice a month for 2 months (total treatment duration = 6 months, 20 meetings). The investigators will recruit adults with overweight or obesity who are high in Food Responsiveness (FR) and will assess them at baseline, post-treatment (month 6), mid-follow-up (month 12) and follow-up (month 18).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Regulation of Cues Enhanced Treatment | Experimental | Behavioral: Regulation of Cues EnhancedThe ROC program provides psychoeducation, coping skills, self-monitoring and experiential learning, and it will be combined with aspects of BWL to capitalize on the strengths of both treatments. |
| Behavioral Weight Loss | Active comparator | Behavioral: Behavioral Weight LossThe BWL program will include dietary recommendations, physical activity recommendations, and behavioral change recommendations. |
| Nutrition, Stress Management, and Social Support | Active comparator | Behavioral: Nutrition Education, Stress Management and Social SupportNutrition Education, Stress Management and Social Support will be covered. Mindfulness will be practiced in every session. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- high Food Responsiveness
- BMI between 25kg/m^2 and 45kg/m^2
- able to read English at a 5th grade reading level
- willing and able to participate in assessment visits and treatment sessions, whether held in-person or via password protected Zoom meetings
- able to provide data through questionnaires
Key exclusion criteria (7 listed)
- major medical conditions such as diabetes or recent history of coronary heart disease; symptoms of angina, stroke, osteoarthritis, osteoporosis, orthopedic problems that would limit activity during the following 18 months; or any other serious medical condition that would make physical activity unsafe
- bulimia or anorexia, significant cognitive impairment, a known psychotic disorder, acute suicidal ideation, moderate or severe alcohol or substance use disorder, or unstable psychiatric illness (e.g., recent psychiatric hospitalization in the past year)
- medical or psychological problems that could make adherence with the study protocol difficult or dangerous
- pregnant, lactating, or planning to become pregnant in the next 18 months
- participating in other weight control programs and/or taking medication for weight loss
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 EnhancedAlso: ROC+ROC is based on the Behavioral Susceptibility Theory and designed to incorporate psychoeducation, cue-exposure treatment, appetite awareness training, coping skills, and self-monitoring of satiety and cravings to treat high Food Responsiveness and low Satiety Responsiveness. BWL and ROC will be integrated for this arm, to capitalize on the strengths of both treatments. All participants will be taught to decrease caloric intake and increase physical activity, and to use all of the behavioral skills provided in BWL. However, they will also be taught models of hunger and satiety and about food cue reactivity, and will learn skills to manage these. This arm will include an experiential component, including hunger monitoring during dinner and participating in exposure exercises. | Behavioural | Regulation of Cues Enhanced Treatment |
| Behavioral Weight LossAlso: BWLThe BWL program includes dietary, physical activity, and behavioral change recommendations. All participants will be instructed on how to consume a balanced deficit diet of conventional foods; individual goals for energy intake will be based on initial body weight. Participants will be instructed in measuring portion sizes, counting calories, and self-monitoring food intake. The physical activity program will focus on increasing both lifestyle activity and structured exercise programs. Behavior change recommendations include stimulus control, self-monitoring, goal setting, managing high-risk situations, meal planning, slowing eating, problem solving, social support, cognitive restructuring, lapse and relapse prevention skills, and maintaining weight loss. | Behavioural | Behavioral Weight Loss |
| Nutrition Education, Stress Management and Social SupportTopics included will be stress management/relaxation, social support, and nutrition education. There will be a strong mindfulness component to this group. | Behavioural | Nutrition, Stress Management, and Social Support |
Primary outcome
Change in Body Mass Index
Time frame: Change from baseline at an average of 6 months, 9 months, 12 months, 15 months, and 18 months
Body Mass Index as measured by height and weight
6 secondary outcomes
Change in Food Responsiveness As Measured by the FR Scale of the AEBQ
Time frame: Change from baseline at an average of 6 months, 12 months, and 18 months
Change in Satiety Responsiveness As Measured by the SR Scale of the AEBQ
Time frame: Change from baseline at an average of 6 months, 12 months, and 18 months
Change in Inhibition As Measured by the Stop Signal Task
Time frame: Change from baseline at an average of 6 months, 12 months, and 18 months
Change in Restriction As Measured by the TFEQ
Time frame: Change from baseline at an average of 6 months, 12 months, and 18 months
Change in Caloric Intake As Measured by the DHQ III
Time frame: Change from baseline at an average of 6 months, 12 months, and 18 months
Change in Eating Cognitions As Measured by the FCQ-T-reduced
Time frame: Change from baseline at an average of 6 months, 12 months, and 18 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 10 Sep 2026.
- Derived from this study: PubMed 40460908Boutelle KN, Eichen DM, Obayashi S, Pasquale EK, Strong DR, Tietz AS, Reed KL, Peterson CB. Design of the SHARE study: A randomized controlled trial evaluating the regulation of cues treatment for adults with overweight or obesity and high food responsiveness. Contemp Clin Trials. 2025 Aug;155:107970. doi: 10.1016/j.cct.2025.107970. Epub 2025 Jun 1.
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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
University of California, San Diego
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 Enhanced, Behavioral Weight Loss and Nutrition Education, Stress Management and Social Support in people with Overweight and Obesity, 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 6 inclusion and 7 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 Sep 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?
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?
Change in Body Mass Index (time frame: Change from baseline at an average of 6 months, 9 months, 12 months, 15 months, and 18 months). 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 NCT05004883, which also lists 1 linked publication.
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 Sep 2026.