Cognitive and Self-regulatory Mechanisms Of Obesity Study (COSMOS)

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Standard Behavioral Treatment (SBT); Behavioral: Acceptance-Based Treatment (ABT)

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.

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.**

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% Weight Loss Post-Treatment	The percentage of weight loss at treatment completion (6 months after baseline).	6 months after baseline
% Weight Loss at Follow-up	The percentage of weight loss at one year after baseline (6 months post-treatment).	One year after baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Insulin Levels	The change in insulin at 6 months and 1 year after baseline.	Baseline to 6-months and Baseline to one-year
Change in Fasting Glucose	The change in fasting glucose at 6 months and 1 year after baseline.	Baseline to 6-months and Baseline to one-year
Change in Hemoglobin A1C	The change in fasting Hemoglobin at 6 months and 1 year after baseline.	Baseline to 6-months and Baseline to one-year
Change in C-Reactive Protein	The change in C-Reactive Protein at 1 year after baseline.	Baseline to one-year
Change in Tumor Necrosis Factor-Alpha	The change in Tumor Necrosis Factor-Alpha at 1 year after baseline.	Baseline to one-year
Change in Interleukin-6	The change in Interleukin-6 at 6 months and 1 year after baseline.	Baseline to one-year
Change in Cognitive Function	Cognitive function measured using the NIH Toolbox - Cognitive Battery	Baseline to 6-months and Baseline to one-year
Change in Self-Regulation	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.	Baseline to 6-months and Baseline to one-year

Collaborators and Investigators

• Sponsor: Oklahoma State University
• Collaborators: University of Oklahoma; University of Minnesota; Case Western Reserve University; Drexel University; Kent State University; Cherokee Nation

Publications and helpful links

General Publications

• Hawkins MAW, Colaizzi J, Gunstad J, Hughes JW, Mullins LL, Betts N, Smith CE, Keirns NG, Vohs KD, Moore SM, Forman EM, Lovallo WR. Cognitive and Self-regulatory Mechanisms of Obesity Study (COSMOS): Study protocol for a randomized controlled weight loss trial examining change in biomarkers, cognition, and self-regulation across two behavioral treatments. Contemp Clin Trials. 2018 Mar;66:20-27. doi: 10.1016/j.cct.2017.12.010. Epub 2017 Dec 22.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): August 1, 2020

Study Registration Dates

• First Submitted: April 12, 2016
• First Submitted That Met QC Criteria: May 25, 2016
• First Posted (Estimate): May 30, 2016

Study Record Updates

• Last Update Posted (Actual): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: AS-15-46

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED