Cognitive and Self-regulatory Mechanisms Of Obesity Study

NCT02786238 | Completed

• 1 other identifier: AS-15-46
• Study Type: interventional
• Target: 156
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• % 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 Outcomes (8)

• Change in Insulin Levels

  Baseline to 6-months and Baseline to one-year

• Change in Fasting Glucose

  Baseline to 6-months and Baseline to one-year

• Change in Hemoglobin A1C

  Baseline to 6-months and Baseline to one-year

• Change in C-Reactive Protein

  Baseline to one-year

• Change in Tumor Necrosis Factor-Alpha

  Baseline to one-year

Study Arms (2)

Standard Behavioral Treatment (SBT)

ACTIVE COMPARATOR

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)

Acceptance-Based Treatment (ABT)

EXPERIMENTAL

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)

Interventions

Standard Behavioral Treatment (SBT) BEHAVIORAL

See description of treatment arm.

Standard Behavioral Treatment (SBT)

Acceptance-Based Treatment (ABT) BEHAVIORAL

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.\*\*

Acceptance-Based Treatment (ABT)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Oklahoma State University: lead
• Kent State University: collaborator
• Case Western Reserve University: collaborator
• University of Minnesota: collaborator
• Drexel University: collaborator
• University of Oklahoma: collaborator
• Cherokee Nation: collaborator

Related Publications (1)

• 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.

  PMID: 29274893 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2016
• First Posted: May 30, 2016
• Study Start: May 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: August 1, 2020
• Last Updated: January 27, 2021

Record last verified: 2021-01