ClinicalTrials.gg
CompletedNCT05004883SHAREUpdated Nov 2, 2026

Solutions for Hunger And Regulating Eating

An interventional study of Regulation of Cues Enhanced and Behavioral Weight Loss in Overweight and Obesity, sponsored by University of California, San Diego. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-02.

Primary conditionObesityRegistry: OverweightReclassifiedWhy we changed it
Registry
Overweight — the first condition term the registry derived for this study.
ClinicalTrials.gg
Obesity
Why
  1. The study's listed conditions name Obesity, a narrower term within Overweight.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of California, San Diego · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
293
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 59 studies in Obesity by University of California, San Diego — 3 open to participants now, 8 under way, none of them phase 3. Obesity · University of California, San Diego.

Enrollment
9th of 51
293 · median 100
Started
2021
the only one that year
No phase
46 of 59
2 open now
Registered
51st of 59
by date

Among the 59 studies in Obesity by University of California, San Diego, this one is the 9th largest by enrollment of the 51 interventional ones that give a count, is the only one that started in 2021, is one of 46 with no phase, and was the 51st registered.

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

Browse Obesity studies →

Open to participants now

3 of the 59 studies in Obesity by University of California, San Diego are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 3 open studies →

Where they have run

Who these studies take

Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 59 studies in Obesity by University of California, San Diego, or all of them as a file.
02

Study 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 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).

03

Conditions studied

  • Overweight and Obesity

Browse trials for

Keywords

  • Food Responsiveness
  • Satiety Responsiveness
  • Weight Loss
  • Overeating
04

In context

Obesity Reclassified

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's enrollment of 293 is above the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

University of California, San Diego is the lead sponsor of 980 studies on the registry; 195 are open to participants now.

Of its 113 completed or terminated interventional studies of FDA-regulated products, 71 (63%) have results posted.

Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • high Food Responsiveness
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

06

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
293 participants (actual)

Study arms

  • Experimental
    Regulation of Cues Enhanced Treatment

    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.

    Behavioral: Regulation of Cues Enhanced

  • Active comparator
    Behavioral Weight Loss

    The BWL program will include dietary recommendations, physical activity recommendations, and behavioral change recommendations.

    Behavioral: Behavioral Weight Loss

  • Active comparator
    Nutrition, Stress Management, and Social Support

    Nutrition Education, Stress Management and Social Support will be covered. Mindfulness will be practiced in every session.

    Behavioral: Nutrition Education, Stress Management and Social Support

Interventions

  • BehavioralRegulation of Cues Enhanced

    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.

    Also known as: ROC+

  • BehavioralBehavioral Weight Loss

    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.

    Also known as: BWL

  • BehavioralNutrition Education, Stress Management and Social Support

    Topics included will be stress management/relaxation, social support, and nutrition education. There will be a strong mindfulness component to this group.

07

What researchers measure

Primary outcomes

  1. Change in Body Mass Index

    Body Mass Index as measured by height and weight

    Time frame: Change from baseline at an average of 6 months, 9 months, 12 months, 15 months, and 18 months

Secondary outcomes

  1. 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.

    Time frame: Change from baseline at an average of 6 months, 12 months, and 18 months

  2. 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.

    Time frame: Change from baseline at an average of 6 months, 12 months, and 18 months

  3. 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.

    Time frame: Change from baseline at an average of 6 months, 12 months, and 18 months

  4. 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.

    Time frame: Change from baseline at an average of 6 months, 12 months, and 18 months

  5. 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.

    Time frame: Change from baseline at an average of 6 months, 12 months, and 18 months

  6. 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.

    Time frame: Change from baseline at an average of 6 months, 12 months, and 18 months

08

Study locations

1 site
  • UCSD Center for Healthy Eating and Activity Research (CHEAR)
    La Jolla, California 92037, United States
09

References and documents

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 ↗
10

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2021 to primary completion in Jun 2026, 57 months.

Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 57 months is above that.

Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 6, 2021
First posted
Aug 13, 2021
StartActual
Sep 1, 2021
Primary completionActual
Jun 10, 2026
CompletionActual
Jun 30, 2026
Last update
Nov 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Nov 2, 2026
Show all 1 update
  1. Nov 2, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT05004883
Responsible party
Kerri Boutelle (Kerri Boutelle, Ph.D., Professor, Herbert Wertheim School of Public Health and Longevity Science and School of Medicine Departments of Pediatrics and Psychiatry, University of California, San Diego) — Principal investigator
First posted
Aug 13, 2021
Start date
Sep 1, 2021
Primary completion
Jun 10, 2026
Completion
Jun 30, 2026
Last update
Nov 2, 2026

Study contacts

Kerri Boutelle, Ph.D.
principal investigator · University of California, San Diego

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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