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

University of California San Diego

Status: Completed

Conditions: Overweight; Obesity

Treatments: Behavioral: Behavioral Weight Loss (BWL); Behavioral: BWL + ROC; Behavioral: Regulation of Cues (ROC); Behavioral: Nutrition Education, Stress Management and Social Support

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02516839

151110

1R01DK103554-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 271 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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271 participants in 4 patient groups

Regulation of Cues (ROC)

Experimental group

Description:

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

Treatment:

Behavioral: Regulation of Cues (ROC)

Behavioral Weight Loss (BWL)

Experimental group

Description:

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

Treatment:

Behavioral: Behavioral Weight Loss (BWL)

BWL+ ROC

Experimental group

Description:

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

Treatment:

Behavioral: BWL + ROC

Nutrition Education, Stress Management Social Support

Active Comparator group

Description:

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

Treatment:

Behavioral: Nutrition Education, Stress Management and Social Support