PACIFIC: Providing Adults Collaborative Interventions For Ideal Changes

Obesity Clinical Trial

— ROC  

Official title:

Treatment of Obesity Targeting Appetite and Cue Reactivity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02516839
• Other study ID #: 151110
• Secondary ID: 1R01DK103554-01A
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: December 27, 2019

Study information

• Verified date: March 2020
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 271
• Est. completion date: December 27, 2019
• Est. primary completion date: December 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	UCSD Center for Healthy Eating and Activity Research (CHEAR)	La Jolla	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Diego	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	body mass index as measured by height and weight		Time Frame: Change from baseline at an average of 12 months and 24 months
Primary	binge eating as measured by the Eating Disorder Examination		Change from baseline at an average of 12 months and 24 months