Clinical trial NCT02516839: PACIFIC: Providing Adults Collaborative Interventions For Ideal Changes
Official title: Treatment of Obesity Targeting Appetite and Cue Reactivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Keywords: Overweight
Obesity
Overeating
Body Mass Index
Weight
Treatment
Cravings
Intervention
Behavioral Treatment
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: National Institutes of Health (NIH)
First posted: 2015-08-06
Enrollment: 271
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: body mass index as measured by height and weight
timeFrame: Time Frame: Change from baseline at an average of 12 months and 24 months
measure: binge eating as measured by the Eating Disorder Examination
timeFrame: Change from baseline at an average of 12 months and 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD Center for Healthy Eating and Activity Research (CHEAR)
state: California
Study officials:
affiliation: UCSD
name: Kerri Boutelle, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.