PACIFIC: Providing Adults Collaborative Interventions For Ideal Changes

Not Applicable

Completed

• Conditions: Obesity; Overweight
• Interventions: Behavioral: Regulation of Cues (ROC); Behavioral: Nutrition Education, Stress Management and Social Support; Behavioral: Behavioral Weight Loss (BWL); Behavioral: BWL + ROC

• Registration Number: NCT02516839
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2015-07-31
• Study First Submitted QC: 2015-08-05
• Study First Posted: 2015-08-06
• Study Start: 2015-09
• Primary Completion: 2019-12-27
• Study Completion: 2019-12-27
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-23
• Last Update Posted: 2020-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 271

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regulation of Cues (ROC)	Regulation of Cues (ROC)	The ROC program provides psychoeducation, coping skills, self-monitoring and experiential learning.
Nutrition Education, Stress Management Social Support	Nutrition Education, Stress Management and Social Support	Nutrition Education, Stress Management and Social Support will be covered. Mindfulness will be practiced in every session.
Behavioral Weight Loss (BWL)	Behavioral Weight Loss (BWL)	The BWL program will include dietary recommendations, physical activity recommendations, and behavioral change recommendations.
BWL+ ROC	BWL + ROC	BWL and ROC will be integrated for this arm, to capitalize on the strengths of both treatments.

Primary Outcome Measures

Name	Time	Method
binge eating as measured by the Eating Disorder Examination	Change from baseline at an average of 12 months and 24 months
body mass index as measured by height and weight	Time Frame: Change from baseline at an average of 12 months and 24 months

Trial Locations

Locations (1)

UCSD Center for Healthy Eating and Activity Research (CHEAR); 🇺🇸 La Jolla, California, United States