NCT01461382已完成不适用
Workplace Intervention: Activity Monitoring as a Tool for Corporate Wellness and Weight Loss
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Daily Physical Activity
研究概览
简要总结
Is a one-year intervention with Treadmill Desks associated with increased employee daily physical activity and decreased sedentariness.
36 employees with sedentary jobs (87 + 27 kg, BMI 29 + 7 kg/m2) used a Treadmill Desk for one year. Daily Physical Activity, work performance, body composition, and blood variables were measured at Baseline and 6 and 12 months after the Treadmill Desk intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects will be recruited regardless of race/ethnicity.
排除标准
- •Definite termination criteria.
- •Request by subject to leave study.
- •Evidence of deliberate non-compliance (e.g.; placing activity instruments on another individual, deliberate destruction of instruments).
- •Pregnancy.
- •Alcohol abuse; elicit drug abuse.
- •Development of chronic condition that is likely to impact on metabolic variables or requiring medications likely to impact on metabolic variables or likely to result in subject being unable to participate (e.g., Grave's disease, hypothyroidism, rheumatoid arthritis requiring steroids or limiting mobility, congestive cardiac failure, neurological disorder such as multiple sclerosis or stroke).
- •Development of acute condition that is likely to impact on metabolic variables or requiring medications likely to impact on metabolic variables or likely to result in subject being unable to participate (e.g., motor vehicle accident with multiple fractures, myocardial infarction, major depression).
- •Potential termination criteria.
- •Development of acute or chronic condition that may impact on metabolic variables or requiring medications likely to impact on metabolic variables or likely to result in subject being unable to participate. Subjects will be reviewed on a subject-by-subject basis and will be reported to the Safety-Monitoring Panel. Specific action plans are pre-assigned for:
- •Diabetes (two fasting plasma glucose values >126 mg/dl). Here, glycosylated hemoglobin will be measured three monthly (by the study) and subjects referred to their local physician for preventative screening. Subjects will be excluded from further study with any glycosylated hemoglobin value of >8% or symptomatic hyperglycemia.
- •Depression or low mood. Here, all patients will be asked to be evaluated by their primary care physician and if appropriate referred to a psychiatrist. The opinion of the psychiatrist will be used to determine continuance or termination in the protocol.
- •This does not represent a comprehensive listing of criteria or causes. All subjects who withdraw or whom are withdrawn from the study or whom are considering/being considered for withdrawal will be referred to the Safety-Monitoring Panel. These subjects' data will be scrutinized (whether terminated or not) separately to assess for association of intervention with a specific adverse outcome.
研究组 & 干预措施
Phase I
Experimental
Entered Study May 2008.
干预措施: Treadmill Desks (Other)
Phase II
Experimental
Phase II entered 6 months after Phase I. Phase II was a no intervention control for 6 months, then followed an identical intervention protocol to Phase I.
干预措施: Treadmill Desks (Other)
结局指标
主要结局
Daily Physical Activity
时间窗: 1 year
Measured for all waking hours using tri-axial accelerometry.
次要结局
- Body Weight(baseline, 6 months, 12 months)
- Body Composition(baseline, 6 months, 12 months)
- Venous blood(baseline, 6 months, 12 months)
- Work performance(baseline, 6 months, 12 months)
研究者
研究点 (1)
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