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

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Regulation of Cues (ROC)
Behavioral Weight Loss (BWL)
BWL + ROC
Nutrition Education, Stress Management and Social Support
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring Overweight, Obesity, Overeating, Body Mass Index, Weight, Treatment, Cravings, Intervention, Behavioral Treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  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.

Sites / Locations

  • UCSD Center for Healthy Eating and Activity Research (CHEAR)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Regulation of Cues (ROC)

Behavioral Weight Loss (BWL)

BWL+ ROC

Nutrition Education, Stress Management Social Support

Arm Description

The ROC program provides psychoeducation, coping skills, self-monitoring and experiential learning.

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

BWL and ROC will be integrated for this arm, to capitalize on the strengths of both treatments.

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

Outcomes

Primary Outcome Measures

body mass index as measured by height and weight
binge eating as measured by the Eating Disorder Examination

Secondary Outcome Measures

Full Information

First Posted
July 31, 2015
Last Updated
March 23, 2020
Sponsor
University of California, San Diego
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT02516839
Brief Title
PACIFIC: Providing Adults Collaborative Interventions For Ideal Changes
Acronym
ROC
Official Title
Treatment of Obesity Targeting Appetite and Cue Reactivity
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
December 27, 2019 (Actual)
Study Completion Date
December 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Overweight, Obesity, Overeating, Body Mass Index, Weight, Treatment, Cravings, Intervention, Behavioral Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
271 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regulation of Cues (ROC)
Arm Type
Experimental
Arm Description
The ROC program provides psychoeducation, coping skills, self-monitoring and experiential learning.
Arm Title
Behavioral Weight Loss (BWL)
Arm Type
Experimental
Arm Description
The BWL program will include dietary recommendations, physical activity recommendations, and behavioral change recommendations.
Arm Title
BWL+ ROC
Arm Type
Experimental
Arm Description
BWL and ROC will be integrated for this arm, to capitalize on the strengths of both treatments.
Arm Title
Nutrition Education, Stress Management Social Support
Arm Type
Active Comparator
Arm Description
Nutrition Education, Stress Management and Social Support will be covered. Mindfulness will be practiced in every session.
Intervention Type
Behavioral
Intervention Name(s)
Regulation of Cues (ROC)
Other Intervention Name(s)
ROC
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Weight Loss (BWL)
Other Intervention Name(s)
BWL
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
BWL + ROC
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nutrition Education, Stress Management and Social Support
Intervention Description
Topics included will be stress management/relaxation, social support, and nutrition education. There will be a strong mindfulness component to this group.
Primary Outcome Measure Information:
Title
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
Title
binge eating as measured by the Eating Disorder Examination
Time Frame
Change from baseline at an average of 12 months and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerri Boutelle, Ph.D.
Organizational Affiliation
UCSD
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Center for Healthy Eating and Activity Research (CHEAR)
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22122291
Citation
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.
Results Reference
background
PubMed Identifier
24459240
Citation
Boutelle 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.
Results Reference
background
PubMed Identifier
35583870
Citation
Boutelle 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.
Results Reference
derived

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PACIFIC: Providing Adults Collaborative Interventions For Ideal Changes

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