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Neuroimaging Study of Factors Related to Exercise

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University of Kansas

Status

Completed

Conditions

Obesity

Treatments

Other: Exercise

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02010463
5R01DK085605 (U.S. NIH Grant/Contract)
5R01DK085605-04

Details and patient eligibility

About

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.

Full description

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

Enrollment

200 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

200 participants in 1 patient group

Exercise Intervention
Other group
Description:
9-month exercise program involving four exercise education sessions
Treatment:
Other: Exercise

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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