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临床试验/NCT02010463
NCT02010463已完成不适用

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

University of Kansas Medical Center4 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2011年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
4
主要终点
Body weight and body composition

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Body weight and body composition

时间窗: Change from Baseline to 9 months

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.

次要结局

  • Body weight and body composition(Change from Baseline to 4 Months)
  • Treadmill testing for maximum oxygen consumption(Change from Baseline to 9 Months)
  • Measurement of Energy Intake(Change from Baseline to 9 Months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joseph Donnelly

Professor

University of Kansas Medical Center

研究点 (4)

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