PACIFIC: Providing Adults Collaborative Interventions For Ideal Changes (ROC)

March 23, 2020 updated by: Kerri Boutelle, University of California, San Diego

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

271

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093
        • UCSD Center for Healthy Eating and Activity Research (CHEAR)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  1. All participants will be between the ages of 18-65 meeting criteria for overweight, with a BMI between 25 and 45.
  2. Participants will provide written informed consent for study participation.
  3. Participants will possess English language skills at the 5th grade reading level.
  4. 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.
  5. 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.
  6. Participants will not be moving out of the San Diego area for the duration of their study enrollment (24 months).
  7. Participants will not be pregnant, planning to get pregnant in the 2 year study period or lactating.
  8. Participants will not be taking medication for weight loss or that may impair physical activity tolerance or performance.
  9. Participants with medical or psychological problems, or taking medications that could make adherence with the study protocol difficult or dangerous will not be included.
  10. Participants cannot have a history of bariatric surgery
  11. Participants cannot currently be enrolled in an organized weight control program.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Regulation of Cues (ROC)
The ROC program provides psychoeducation, coping skills, self-monitoring and experiential learning.
Behavioral: Regulation of Cues (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.
Other Names:
  • ROC
Experimental: Behavioral Weight Loss (BWL)
The BWL program will include dietary recommendations, physical activity recommendations, and behavioral change recommendations.
Behavioral: Behavioral Weight Loss (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.
Other Names:
  • BWL
Experimental: BWL+ ROC
BWL and ROC will be integrated for this arm, to capitalize on the strengths of both treatments.
Behavioral: BWL + ROC
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.
Active Comparator: Nutrition Education, Stress Management 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
Topics included will be stress management/relaxation, social support, and nutrition education. There will be a strong mindfulness component to this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
Change from baseline at an average of 12 months and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

December 27, 2019

Study Completion (Actual)

December 27, 2019

Study Registration Dates

First Submitted

July 31, 2015

First Submitted That Met QC Criteria

August 5, 2015

First Posted (Estimate)

August 6, 2015

Study Record Updates

Last Update Posted (Actual)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 23, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 151110
  • 1R01DK103554-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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