Cognitive and Self-regulatory Mechanisms Of Obesity Study
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Standard Behavioral Treatment (SBT); Acceptance-Based Treatment (ABT)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): See description of treatment arm.; 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.**
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment