Cognitive and Self-regulatory Mechanisms Of Obesity Study
Cognitive and Self-regulatory Mechanisms Of Obesity Study
This study will be the first clinical trial to examine the impact of two different weight
 loss interventions on novel mechanisms that promote obesity and impede its successful
 treatment, including cognitive function and self-regulatory factors. The results will provide
 important data about how impaired cognitive function and/or self-regulation promote obesity
 and how different weight loss treatments may differentially impact these factors; this
 information will be used to identify promising cognitive and self-regulatory treatment
 targets for preventing further obesity development and for maintaining weight loss.
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.
Inclusion Criteria:

 -  >21 years old

 -  <65 years old

 -  BMI > 27

 -  BMI < 52

 -  Attended Information/Recruitment session

 -  **For Cherokee Nation arm of the study only, participants must endorse Native
 American/American Indian racial identity (POWER-UP).

 Exclusion Criteria:

 -  Age out of stated range

 -  BMI out of stated range

 -  Physician says physical activity is contraindicated (won't sign off) or participant
 meets the criteria on the Physical Activity Readiness Questionnaire (PARQ) for need a
 physician signature and doesn't obtain one.

 -  History of bariatric surgery or planning to get surgery over next 12 months

 -  Pregnant, planning to become pregnant over next 12 months

 -  Currently breastfeeding

 -  Failure of Independence (a family member/friend enrolling in study)

 -  History or current serious eating disorder pathology

 -  Current severe depression or suicidal ideation

 -  Current severe anxiety

 -  History or current substance use disorder

 -  History of hypomanic or manic episode

 -  History of psychotic episode

 -  History of neurological disorder or head injury (e.g., stroke, epilepsy, loss of
 consciousness >10 min)

 -  Recent significant weight loss

 -  Current Type I Diabetes

 -  Medications or disease that impact weight (e.g., mirtazapine, prednisone,
 dexamethasone, dronabinol, megestrol, Cushing's syndrome). The exclusion of persons
 with hypothyroidism was discontinued given very high base rates in recruitment sample.
 We will run sensitivity analyses by those with and without hypothyroidism.