Clinical trial NCT02010463: Neuroimaging Study of Factors Related to Exercise
Official title: Neuroimaging Studies of Reward, Impulsivity, and Adherence to an Exercise Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: reward processing
impulse control
obese
clinically obese
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2013-12-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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.
* 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

Primary outcomes:
measure: Body weight and body composition
timeFrame: Change from Baseline to 9 months
Secondary outcomes:
measure: Body weight and body composition
timeFrame: Change from Baseline to 4 Months
measure: Treadmill testing for maximum oxygen consumption
timeFrame: Change from Baseline to 4 Months
measure: Treadmill testing for maximum oxygen consumption
timeFrame: Change from Baseline to 9 Months
measure: Measurement of Energy Intake
timeFrame: Change from Baseline to 4 Months
measure: Measurement of Energy Intake
timeFrame: Change from Baseline to 9 Months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Lawrence
country: United States
facility: University of Kansas
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Cary Savage, PhD
role: PRINCIPAL_INVESTIGATOR
References: