PACIFIC: Providing Adults Collaborative Interventions For Ideal Changes



Status:Active, not recruiting
Conditions:Obesity Weight Loss, Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 65
Updated:11/23/2017
Start Date:September 2015
End Date:March 2020

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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.

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.

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.
We found this trial at
1
site
La Jolla, California 92093
Principal Investigator: Kerri Boutelle, PhD
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mi
from
La Jolla, CA
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