Overview

This trial is active, not recruiting.

Condition obesity
Treatment exercise
Sponsor University of Kansas Medical Center
Collaborator National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date October 2011
End date December 2016
Trial size 200 participants
Trial identifier NCT02010463, 5R01DK085605, 5R01DK085605-04

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose basic science
Arm
(Other)
9-month exercise program involving four exercise education sessions
exercise

Primary Outcomes

Measure
Body weight and body composition
time frame: Change from Baseline to 9 months

Secondary Outcomes

Measure
Body weight and body composition
time frame: Change from Baseline to 4 Months
Treadmill testing for maximum oxygen consumption
time frame: Change from Baseline to 4 Months
Treadmill testing for maximum oxygen consumption
time frame: Change from Baseline to 9 Months
Measurement of Energy Intake
time frame: Change from Baseline to 4 Months
Measurement of Energy Intake
time frame: Change from Baseline to 9 Months

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

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. - Serious medical risks such as type 1-diabetes, cancer, recent cardiac event (i.e. heart attack, angioplasty, etc.) - High blood pressure - Current use of smoking/tobacco products or initiation of the use of smoking/tobacco products during the study and alcohol abuse and any history of dependence - Subject IQ is less that 80 - Reported radiation exposure from CT, PET, fluoroscopic or nuclear medicine studies within the previous year, or other radiation exposure at the discretion of the PI

Additional Information

Official title Neuroimaging Studies of Reward, Impulsivity, and Adherence to an Exercise Program
Principal investigator Cary Savage, PhD
Description This is a nonrandomized trial with groups being defined by BMI and adherence status to the exercise intervention.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University of Kansas Medical Center.