PACIFIC: Providing Adults Collaborative Interventions For Ideal Changes

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.

Conditions

• Overweight
• Obesity

Interventions

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

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• National Institutes of Health (NIH)

  collaborator NIH

• University of California, San Diego

  lead OTHER

Principal Investigators

• Kerri Boutelle, Ph.D. · UCSD

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-09-30

Primary Completion

2019-12-27

Completion

2019-12-27

Countries

• United States

Study Locations