OverweightROCNCT02516839
PACIFIC: Providing Adults Collaborative Interventions For Ideal Changes
A study testing Regulation of Cues (ROC), Behavioral Weight Loss (BWL) and BWL + ROC 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 initial efficacy data on ROC and ROC + BWL compared to an active comparator (AC) and to BWL. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Regulation of Cues (ROC), Behavioral Weight Loss (BWL) and BWL + ROC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 271 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to 27 Dec 2019
- 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
- All participants will be between the ages of 18-65 meeting criteria for overweight, with a BMI between 25 and 45.
- Participants will provide written informed consent for study participation.
- Participants will possess English language skills at the 5th grade reading level.
- Participants will be free of major medical conditions such as a recent history of coronary heart disease; recent history of myocardial infarction; recent symptoms of angina, diabetes, recent stroke, orthopedic problems that would limit activity during the following twelve months; or any other serious medical condition that would make physical activity unsafe.
- Participants will not have bulimia or anorexia, significant cognitive impairment, a known psychotic disorder, or unstable psychiatric illness (e.g., recent psychiatric hospitalization, acute suicidal ideation) as derived from their intake interview and questionnaires.
- Participants will not be moving out of the San Diego area for the duration of their study enrollment (24 months).
- Participants will not be pregnant, planning to get pregnant in the 2 year study period or lactating.
- Participants will not be taking medication for weight loss or that may impair physical activity tolerance or performance.
- Participants with medical or psychological problems, or taking medications that could make adherence with the study protocol difficult or dangerous will not be included.
- Participants cannot have a history of bariatric surgery
- Participants cannot currently be enrolled in an organized weight control program.
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: Treatment of Obesity Targeting Appetite and Cue Reactivity
The objective of this proposed study is to collect initial efficacy data on ROC and ROC + BWL compared to an active comparator (AC) and to BWL.
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. The ROC program targets two theorized mechanisms for overeating in Schachter's Theory; 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 ROC, BWL, ROC+BWL combined and an active comparator (AC). The investigators will recruit overweight/obese adults and will assess them at baseline, mid-treatment (month 6), post-treatment (month 12), mid-follow-up (month 18) and follow-up (month 24). Assessments will include body mass index (BMI), body composition, and binge eating over the course of treatment and follow-up. This study will contribute to the study of basic behavioral mechanisms and food intake, could provide a novel model for the treatment of obesity, and could inform clinical decision making regarding obesity treatment.
- Conditions
- Overweight, Obesity
- Being tested
- Regulation of Cues (ROC), Behavioral Weight Loss (BWL), BWL + ROC, Nutrition Education, Stress Management and Social Support
- Keywords
- Overweight, Obesity, Overeating, Body Mass Index, Weight, Treatment, Cravings, Intervention, Behavioral Treatment
- Medical subject headings
- Overweight, Obesity, 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.
Behavioral Weight Loss (BWL)Behavioural
Also called BWL
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 (with a calorie counter provided or on their phone), 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.
BWL + ROCBehavioural
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 sessions in the clinic.
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 (ROC) | Experimental | The ROC program provides psychoeducation, coping skills, self-monitoring and experiential learning. Receives: Behavioral: Regulation of Cues (ROC) |
| Behavioral Weight Loss (BWL) | Experimental | The BWL program will include dietary recommendations, physical activity recommendations, and behavioral change recommendations. Receives: Behavioral: Behavioral Weight Loss (BWL) |
| BWL+ ROC | Experimental | BWL and ROC will be integrated for this arm, to capitalize on the strengths of both treatments. Receives: Behavioral: BWL + ROC |
| Nutrition Education, Stress Management 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.
body mass index as measured by height and weight
Measured: Time Frame: Change from baseline at an average of 12 months and 24 months
binge eating as measured by the Eating Disorder Examination
Measured: Change from baseline at an average of 12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2015 (estimated)
- Study startSep 2015
- Primary completion27 Dec 2019
- Study completion27 Dec 2019
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 OverweightStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)
- 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
- NCT02516839
- Sponsor's protocol ID
- 151110
- Other IDs
- 1R01DK103554-01A1
- Acronym
- ROC
- Status last verified
- Mar 2020
- First submitted
- 31 Jul 2015
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
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, Pasquale EK, Strong DR, Eichen DM, Peterson CB. Reduction in eating disorder symptoms among adults in different weight loss interventions. Eat Behav. 2023 Dec;51:101787. doi: 10.1016/j.eatbeh.2023.101787. Epub 2023 Jul 24.
PubMed 37639734Boutelle KN, Eichen DM, Peterson CB, Strong DR, Kang-Sim DE, Rock CL, Marcus BH. Effect of a Novel Intervention Targeting Appetitive Traits on Body Mass Index Among Adults With Overweight or Obesity: A Randomized Clinical Trial. JAMA Netw Open. 2022 May 2;5(5):e2212354. doi: 10.1001/jamanetworkopen.2022.12354.
PubMed 35583870
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Obesity Targeting Appetite and Cue Reactivity
- ClinicalTrials.gov ID
- NCT02516839
- Acronym / sponsor ID
- ROC / 151110
- Conditions
- Overweight, Obesity
- Keywords
- Overweight, Obesity, Overeating, Body Mass Index, Weight, Treatment, Cravings, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)
- Study start
- Sep 2015
- Primary completion
- 27 Dec 2019 (actual)
- Study completion
- 27 Dec 2019 (actual)
- First posted
- 6 Aug 2015 (estimated)
- 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 initial efficacy data on ROC and ROC + BWL compared to an active comparator (AC) and to BWL.
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. The ROC program targets two theorized mechanisms for overeating in Schachter's Theory; 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 ROC, BWL, ROC+BWL combined and an active comparator (AC). The investigators will recruit overweight/obese adults and will assess them at baseline, mid-treatment (month 6), post-treatment (month 12), mid-follow-up (month 18) and follow-up (month 24). Assessments will include body mass index (BMI), body composition, and binge eating over the course of treatment and follow-up. This study will contribute to the study of basic behavioral mechanisms and food intake, could provide a novel model for the treatment of obesity, and could inform clinical decision making regarding obesity treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Regulation of Cues (ROC) | Experimental | Behavioral: Regulation of Cues (ROC)The ROC program provides psychoeducation, coping skills, self-monitoring and experiential learning. |
| Behavioral Weight Loss (BWL) | Experimental | Behavioral: Behavioral Weight Loss (BWL)The BWL program will include dietary recommendations, physical activity recommendations, and behavioral change recommendations. |
| BWL+ ROC | Experimental | Behavioral: BWL + ROCBWL and ROC will be integrated for this arm, to capitalize on the strengths of both treatments. |
| Nutrition Education, Stress Management 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
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) |
| Behavioral Weight Loss (BWL)Also: BWLAll 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 (with a calorie counter provided or on their phone), 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 (BWL) |
| BWL + ROCBWL 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 sessions in the clinic. | Behavioural | BWL+ ROC |
| 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 Education, Stress Management Social Support |
Primary outcome
body mass index as measured by height and weight
Time frame: Time Frame: Change from baseline at an average of 12 months and 24 months
binge eating as measured by the Eating Disorder Examination
Time frame: Change from baseline at an average of 12 months and 24 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 25 Mar 2020.
- 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 37639734Boutelle KN, Pasquale EK, Strong DR, Eichen DM, Peterson CB. Reduction in eating disorder symptoms among adults in different weight loss interventions. Eat Behav. 2023 Dec;51:101787. doi: 10.1016/j.eatbeh.2023.101787. Epub 2023 Jul 24.
- Derived from this study: PubMed 35583870Boutelle KN, Eichen DM, Peterson CB, Strong DR, Kang-Sim DE, Rock CL, Marcus BH. Effect of a Novel Intervention Targeting Appetitive Traits on Body Mass Index Among Adults With Overweight or Obesity: A Randomized Clinical Trial. JAMA Netw Open. 2022 May 2;5(5):e2212354. doi: 10.1001/jamanetworkopen.2022.12354.
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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), Behavioral Weight Loss (BWL) and BWL + ROC 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?
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 25 Mar 2020. 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?
body mass index as measured by height and weight (time frame: Time Frame: Change from baseline at an average of 12 months and 24 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 NCT02516839, 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 25 Mar 2020.