NCT02010463 - Neuroimaging Study of Factors Related to Exercise | Crick

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

NA

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

200

Conditions

Obesity

Interventions

ExerciseOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

University of Kansas Medical Center

Kansas City, Kansas, United States

University of Kansas

Lawrence, Kansas, United States

Outcomes

Primary Outcomes

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.

Time frame: Change from Baseline to 9 months

Secondary Outcomes

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.

Time frame: 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).

Time frame: 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).