Neuroimaging Study of Factors Related to Exercise

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Other: Exercise

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
    • Lawrence, Kansas, United States, 66045
      • University of Kansas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Exercise Intervention; 9-month exercise program involving four exercise education sessions	Other: Exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight and body composition	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.	Change from Baseline to 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight and body composition	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.	Change from Baseline to 4 Months
Treadmill testing for maximum oxygen consumption	Participants will undergo a physician supervised maximal treadmill test to assess changes in maximal oxygen consumption. Furthermore, maximal heart rate obtained from the baseline test will be used to target the appropriate exercise intensity. Participants will walk at 3.4 mph beginning at 0% grade. The grade will be increased 2.5% at 2 minute intervals until exhaustion occurs. Heart rates will be recorded at one minute intervals with a multiple channel electrocardiograph. Expired air will be measured for oxygen and carbon dioxide at 20-second intervals using a ParvoMedics TrueOne 2400 indirect calorimetry system. The system will be and calibrated before each test according to the specifications of the manufacturer (ParvoMedics, Inc Sandy, Utah). Maximal oxygen consumption will be considered as the highest observed value (American College of Sports Medicine 2000).	Change from Baseline to 4 Months
Treadmill testing for maximum oxygen consumption	Participants will undergo a physician supervised maximal treadmill test to assess changes in maximal oxygen consumption. Furthermore, maximal heart rate obtained from the baseline test will be used to target the appropriate exercise intensity. Participants will walk at 3.4 mph beginning at 0% grade. The grade will be increased 2.5% at 2 minute intervals until exhaustion occurs. Heart rates will be recorded at one minute intervals with a multiple channel electrocardiograph. Expired air will be measured for oxygen and carbon dioxide at 20-second intervals using a ParvoMedics TrueOne 2400 indirect calorimetry system. The system will be and calibrated before each test according to the specifications of the manufacturer (ParvoMedics, Inc Sandy, Utah). Maximal oxygen consumption will be considered as the highest observed value (American College of Sports Medicine 2000).	Change from Baseline to 9 Months
Measurement of Energy Intake	Participants will be asked not to alter their dietary intake during the intervention. Dietary intake will be documented from 3-day food records (2 weekdays, 1 weekend day). The nutrient content of the record data will be determined using Nutrition Data System for Research (NDS-R, version 2008, University of Minnesota, Minneapolis, MN).	Change from Baseline to 4 Months
Measurement of Energy Intake	Participants will be asked not to alter their dietary intake during the intervention. Dietary intake will be documented from 3-day food records (2 weekdays, 1 weekend day). The nutrient content of the record data will be determined using Nutrition Data System for Research (NDS-R, version 2008, University of Minnesota, Minneapolis, MN).	Change from Baseline to 9 Months

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Cary Savage, PhD, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2011
• Primary Completion (Actual): December 30, 2019
• Study Completion (Actual): January 15, 2020

Study Registration Dates

• First Submitted: December 9, 2013
• First Submitted That Met QC Criteria: December 9, 2013
• First Posted (Estimate): December 12, 2013

Study Record Updates

• Last Update Posted (Actual): March 25, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: obese; reward processing; impulse control; clinically obese
• Other Study ID Numbers: 5R01DK085605-04 (U.S. NIH Grant/Contract); 5R01DK085605 (U.S. NIH Grant/Contract)