Neuroimaging Studies of Reward, Impulsivity, and Adherence to an Exercise Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 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
- 是
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
研究组 & 干预措施
Exercise Intervention
9-month exercise program involving four exercise education sessions
干预措施: Exercise (Other)
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)
- Treadmill testing for maximum oxygen consumption(Change from Baseline to 4 Months)
- Measurement of Energy Intake(Change from Baseline to 4 Months)
研究者
Joseph Donnelly
Professor
University of Kansas Medical Center