PACIFIC: Providing Adults Collaborative Interventions For Ideal Changes (ROC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02516839|
Recruitment Status : Active, not recruiting
First Posted : August 6, 2015
Last Update Posted : November 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Overweight Obesity||Behavioral: Regulation of Cues (ROC) Behavioral: Behavioral Weight Loss (BWL) Behavioral: BWL + ROC Behavioral: Nutrition Education, Stress Management and Social Support||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||281 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Treatment of Obesity Targeting Appetite and Cue Reactivity|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||March 2020|
Experimental: Regulation of Cues (ROC)
The ROC program provides psychoeducation, coping skills, self-monitoring and experiential learning.
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.
Other Name: ROC
Experimental: Behavioral Weight Loss (BWL)
The BWL program will include dietary recommendations, physical activity recommendations, and behavioral change recommendations.
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.
Other Name: BWL
Experimental: BWL+ ROC
BWL and ROC will be integrated for this arm, to capitalize on the strengths of both treatments.
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.
Active Comparator: Nutrition Education, Stress Management Social Support
Nutrition Education, Stress Management and Social Support will be covered. Mindfulness will be practiced in every session.
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.
- body mass index as measured by height and weight [ Time Frame: Time Frame: Change from baseline at an average of 12 months and 24 months ]
- fat free mass as measured by dual energy x-ray absorptiometry (DXA) [ Time Frame: Change from baseline at an average of 12 months and 24 months ]
- fat mass as measured by dual energy x-ray absorptiometry (DXA) [ Time Frame: Change from baseline at an average of 12 months and 24 months ]
- binge eating as measured by the Eating Disorder Examination [ Time Frame: Change from baseline at an average of 12 months and 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02516839
|United States, California|
|UCSD Center for Healthy Eating and Activity Research (CHEAR)|
|La Jolla, California, United States, 92093|
|Principal Investigator:||Kerri Boutelle, Ph.D.||UCSD|