Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK103554-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| National Institutes of Health (NIH) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regulation of Cues (ROC) | Experimental | The ROC program provides psychoeducation, coping skills, self-monitoring and experiential learning. |
|
| Behavioral Weight Loss (BWL) | Experimental | The BWL program will include dietary recommendations, physical activity recommendations, and behavioral change recommendations. |
|
| BWL+ ROC | Experimental | BWL and ROC will be integrated for this arm, to capitalize on the strengths of both treatments. |
|
| Nutrition Education, Stress Management Social Support | Active Comparator | Nutrition Education, Stress Management and Social Support will be covered. Mindfulness will be practiced in every session. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regulation of Cues (ROC) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| body mass index as measured by height and weight | Time Frame: Change from baseline at an average of 12 months and 24 months | |
| binge eating as measured by the Eating Disorder Examination | Change from baseline at an average of 12 months and 24 months |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kerri Boutelle, Ph.D. | UCSD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Center for Healthy Eating and Activity Research (CHEAR) | La Jolla | California | 92093 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22122291 | Background | Boutelle KN, Zucker NL, Peterson CB, Rydell SA, Cafri G, Harnack L. Two novel treatments to reduce overeating in overweight children: a randomized controlled trial. J Consult Clin Psychol. 2011 Dec;79(6):759-71. doi: 10.1037/a0025713. | |
| 24459240 | Background | Boutelle KN, Zucker N, Peterson CB, Rydell S, Carlson J, Harnack LJ. An intervention based on Schachter's externality theory for overweight children: the regulation of cues pilot. J Pediatr Psychol. 2014 May;39(4):405-17. doi: 10.1093/jpepsy/jst142. Epub 2014 Jan 23. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D006963 | Hyperphagia |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Behavioral Weight Loss (BWL) | Behavioral | 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. |
|
|
| BWL + ROC | Behavioral | 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. |
|
| Nutrition Education, Stress Management and Social Support | Behavioral | Topics included will be stress management/relaxation, social support, and nutrition education. There will be a strong mindfulness component to this group. |
|
| 37639734 | Derived | Boutelle KN, Pasquale EK, Strong DR, Eichen DM, Peterson CB. Reduction in eating disorder symptoms among adults in different weight loss interventions. Eat Behav. 2023 Dec;51:101787. doi: 10.1016/j.eatbeh.2023.101787. Epub 2023 Jul 24. |
| 35583870 | Derived | Boutelle KN, Eichen DM, Peterson CB, Strong DR, Kang-Sim DE, Rock CL, Marcus BH. Effect of a Novel Intervention Targeting Appetitive Traits on Body Mass Index Among Adults With Overweight or Obesity: A Randomized Clinical Trial. JAMA Netw Open. 2022 May 2;5(5):e2212354. doi: 10.1001/jamanetworkopen.2022.12354. |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |