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

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ClinicalTrials.gov Identifier: NCT02516839
Recruitment Status : Active, not recruiting
First Posted : August 6, 2015
Last Update Posted : November 21, 2017
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Kerri Boutelle, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Overweight Obesity Behavioral: Regulation of Cues (ROC) Behavioral: Behavioral Weight Loss (BWL) Behavioral: BWL + ROC Behavioral: Nutrition Education, Stress Management and Social Support Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 281 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Obesity Targeting Appetite and Cue Reactivity
Study Start Date : September 2015
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : March 2020

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 Name: 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 Name: 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.




Primary Outcome Measures :
  1. 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 ]
  2. fat free mass as measured by dual energy x-ray absorptiometry (DXA) [ Time Frame: Change from baseline at an average of 12 months and 24 months ]
  3. fat mass as measured by dual energy x-ray absorptiometry (DXA) [ Time Frame: Change from baseline at an average of 12 months and 24 months ]
  4. binge eating as measured by the Eating Disorder Examination [ Time Frame: Change from baseline at an average of 12 months and 24 months ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02516839


Locations
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United States, California
UCSD Center for Healthy Eating and Activity Research (CHEAR)
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Kerri Boutelle, Ph.D. UCSD

Publications:
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Responsible Party: Kerri Boutelle, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02516839     History of Changes
Other Study ID Numbers: 151110
1R01DK103554-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 6, 2015    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: November 2017

Keywords provided by Kerri Boutelle, University of California, San Diego:
Overweight
Obesity
Overeating
Body Mass Index
Weight
Treatment
Cravings
Intervention
Behavioral Treatment

Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms