Neuroimaging Studies of Reward, Impulsivity, and Adherence to an Exercise Program

University of Kansas Medical Center2 sites in 1 country200 target enrollmentOctober 2011

ConditionsObesity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Obesity
Sponsor: University of Kansas Medical Center
Enrollment: 200
Locations: 2
Primary Endpoint: Body weight and body composition
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study aims to support the hypothesis that brain processes underlying reward processing and impulse control contribute to obesity and to adherence in a new exercise regimen.

Detailed Description

This is a nonrandomized trial with groups being defined by BMI and adherence status to the exercise intervention.

Registry

clinicaltrials.gov

Start Date

October 2011

End Date

January 15, 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Kansas Medical Center

Responsible Party

Principal Investigator

Joseph Donnelly

Professor

University of Kansas Medical Center

Eligibility Criteria

Inclusion Criteria

•BMI \>25 to \< 40±1
•Must live in the Greater Kansas City area for at least 1 year
•Willing to exercise
•Provide written approval from a licensed physician that they are healthy enough to participate in a program of moderate physical activity and maximum O2 testing
•All participants must be sedentary except for casual recreation such as softball, bowling, etc.

Exclusion Criteria

•Color-blindness
•Left-handedness
•Any diagnosed neurological disorder or conditions that preclude MRI scanning (e.g., metal in body)
•Participation in a research project involving weight loss or physical activity in the previous 6 months
•Subjects who smoke
•Subjects use medications that affect metabolism (i.e. thyroid, beta blockers), use medications that affect appetite (i.e. Meridia) or cannot exercise (i.e. walk)
•Participants will be excluded by study personnel following interview if they exhibit eating disorders, binge eating, depression or drug addiction
•Metabolic disease that would affect energy balance (e.g. diabetes mellitus or hypothyroidism)
•Pregnant during the previous 6 months, are lactating, or plan pregnancy within 12 months
•Individuals who are not weight stable (± 4.5kg) within the previous year.

Outcomes

Primary Outcomes

Body weight and body composition

Time Frame: Change from Baseline to 9 months

Body weights will be recorded using a digital scale accurate to + 0.1 kg (Befour Inc Model #PS6600, Saukville, WI). Participants will report to the Center between 7 and 10 AM and will be weighed prior to breakfast and after attempting to void. Participants will wear a standard hospital gown at the time of weighing.

Secondary Outcomes

Body weight and body composition(Change from Baseline to 4 Months)
Treadmill testing for maximum oxygen consumption(Change from Baseline to 9 Months)
Measurement of Energy Intake(Change from Baseline to 9 Months)