Cognitive and Self-regulatory Mechanisms Of Obesity Study (COSMOS)
|ClinicalTrials.gov Identifier: NCT02786238|
Recruitment Status : Active, not recruiting
First Posted : May 30, 2016
Last Update Posted : June 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Behavioral: Standard Behavioral Treatment (SBT) Behavioral: Acceptance-Based Treatment (ABT)||Not Applicable|
This K23 award will allow Dr. Misty Hawkins, a clinical psychologist with expertise in behavioral medicine and obesity, to further develop into an independent investigator proficient in physiological, neuropsychological, and self-regulatory research methods and interventions that will allow her to study novel mechanisms of and treatments for obesity maintenance. She has a career interest in intervening on the neuropsychological factors related to obesity. Her research goal is to identify novel cognitive and self-regulatory mechanisms of obesity in this pilot trial which can then be targeted in larger randomized controlled trials (RCTs) to reduce obesity development or to maintain weight loss. Obesity continues to be a global epidemic, yet successful interventions for obesity are rare, with 80% of individuals in treatment programs being unsuccessful at achieving long-term weight loss. The training and research activities in this K23 application will allow her to examine the complexities of physiological dysregulation, cognitive deficits, and self-regulatory failure in an obesity treatment study. The application proposes an intensive, 5-year program of mentored research and formal training activities to enhance Dr. Hawkins' skills and experience in: 1) basic research on and assessment of cognitive function; (2) assessment of obesity-related physiological changes; (3) research with patient populations; (4) advanced assessment of self-regulation (SR); and (5) the conduct of randomized clinical trials and advanced statistics. In the long term, Dr. Hawkins will apply these translational research skills to study targeted cognitive and self-regulation interventions as potentially effective treatments for persons with obesity who may exhibit cognitive deficits or chronic self-regulatory failure. The research component of this career development award is a clinical trial examining the impact of two different weight loss treatments on physiological markers, cognition, self-regulation, and health behaviors in 96 obese persons. The specific aims are to: 1) Confirm that baseline obesity-related physiological dysregulation is linked to cognitive deficits, poorer self-regulation, and obesogenic behaviors, 2) Demonstrate that the two treatment groups have improvements in biomarkers, cognition, SR, and obesogenic behaviors, less weight gain, and greater weight loss, and 3) Evaluate whether the acceptance-based treatment (ABT) group has greater improvements in biomarkers, cognition, SR, and obesogenic behaviors, less weight gain, and greater weight loss than the standard behavioral treatment group (SBT) from pre- to post-treatment and 1-year follow-up. Oklahoma State University and its research partner Oklahoma University Health Sciences Center provide exceptional environments for Dr. Hawkins to gain the skills needed to achieve her goals. The training component uses academic resources including the College of Arts and Sciences and the Department of Psychology. Dr. Hawkins' mentors are highly regarded scientists in the areas of obesity, neuropsychology, psychophysiology, nutrition, and patient-oriented research.
**An open trial arm of ABT was added to the study in September 2016 to test feasibility of ABT among members of Cherokee Nation. This arm is entitled POWER-UP: Pilot Of WEight Reduction in Underserved Populations. Glucose is the only biomarker being measured in POWER-UP.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Cognitive and Self-regulatory Mechanisms Of Obesity Study|
|Actual Study Start Date :||May 2016|
|Actual Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||August 2020|
Active Comparator: Standard Behavioral Treatment (SBT)
For the Standard Behavioral Treatment (SBT) condition, participants will participate in the standard behavioral weight loss programming, which utilizes strategies from existing obesity treatments (e.g., the Diabetes Prevention Program). These features include the following: 1) nutritional education, 2) diet and physical activity, 3) expectations for daily self-monitoring of calorie intake and activity, 4) stimulus control, behavior shaping, behavior analysis, and relapse prevention strategies, and 5) social support.
Behavioral: Standard Behavioral Treatment (SBT)
See description of treatment arm.
Experimental: Acceptance-Based Treatment (ABT)
The Acceptance-Based Treatment (ABT) group will receive most features listed in the SBT arm as well as unique ABT training designed to help individuals increase awareness of their cognitive and affective experiences, and the following exercises: 1) identifying weight-related goals from personal life values (e.g., health) and connecting these values to day-to-day eating, 2) increasing awareness of moment-by-moment behavior choices, 3) tolerating aversive internal states that include eating-related states as well as affective states such as stress, sadness, and anxiety (i.e., "urge-surfing"). These strategies that have been empirically tested and found to be effective in the NIH-funded Mind Your Health RCT (R21DK080430).
Behavioral: Acceptance-Based Treatment (ABT)
See description of treatment arm. **Cherokee Nation members receive only the ABT intervention as they are in an open, feasibility trial and are not randomized.**
- % Weight Loss Post-Treatment [ Time Frame: 6 months after baseline ]The percentage of weight loss at treatment completion (6 months after baseline).
- % Weight Loss at Follow-up [ Time Frame: One year after baseline ]The percentage of weight loss at one year after baseline (6 months post-treatment).
- Change in Insulin Levels [ Time Frame: Baseline to 6-months and Baseline to one-year ]The change in insulin at 6 months and 1 year after baseline.
- Change in Fasting Glucose [ Time Frame: Baseline to 6-months and Baseline to one-year ]The change in fasting glucose at 6 months and 1 year after baseline.
- Change in Hemoglobin A1C [ Time Frame: Baseline to 6-months and Baseline to one-year ]The change in fasting Hemoglobin at 6 months and 1 year after baseline.
- Change in C-Reactive Protein [ Time Frame: Baseline to one-year ]The change in C-Reactive Protein at 1 year after baseline.
- Change in Tumor Necrosis Factor-Alpha [ Time Frame: Baseline to one-year ]The change in Tumor Necrosis Factor-Alpha at 1 year after baseline.
- Change in Interleukin-6 [ Time Frame: Baseline to one-year ]The change in Interleukin-6 at 6 months and 1 year after baseline.
- Change in Cognitive Function [ Time Frame: Baseline to 6-months and Baseline to one-year ]Cognitive function measured using the NIH Toolbox - Cognitive Battery
- Change in Self-Regulation [ Time Frame: Baseline to 6-months and Baseline to one-year ]Self-regulation measured using two self-report questionnaires and two behavioral tasks. Scores on these tasks will be converted to z-scores and then aggregated into one measure.