NCT02774655已完成不适用
New Health Devices to Improve Adherence to Physical Activity in Overweight Inactive Adults
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The proportion of the participants obtaining 80 % or more of the prescribed physical activity for one year
研究概览
简要总结
The purpose of this study is to test in overweight and inactive adults whether the new PAI eHealh APP leads to better adherence to a physical activity regimen than the wearable step counter App from the market leader FitBit, and to evaluate if improved adherence will be reflected in a better cardiovascular profile in this group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index > 25
- •self reported exercise one time or less per week
排除标准
- •inability to use a SmartPhone
- •illness or disabilities that preclude or hinder completion of the study
- •cancer that makes participation impossible or exercise contraindicated (considered individually, in consultation with physician)
- •test results indicating that study participation is unsafe
- •participation in other studies conflicting with participation in this study
- •symptomatic valvular, hypertrophic cardiomyopathy, unstable angina, primary pulmonary hypertension, uncontrolled hypertension, heart failure or sever arrhythmia
- •diagnosed dementia
- •chronic communicable infectious diseases
- •Bariatric surgery
- •Medication for thyroid disease, diabetes, blood pressure or lipid lowering medication
研究组 & 干预措施
PAI APP
Experimental
personal activity index application
干预措施: Pai APP (Device)
FitBit APP
Active Comparator
干预措施: FitBit APP (Device)
结局指标
主要结局
The proportion of the participants obtaining 80 % or more of the prescribed physical activity for one year
时间窗: 1 year
Prescribed 100 PAI weekly (PAI app group), or 10 000 steps daily (step counter app)
次要结局
- Cardiorespiratory fitness(16 weeks)
- Resting blood pressure(1 year)
- Resting heart rate(1 year)
- Body mass index(1 year)
- Waist line(1 year)
- Body composition(1 year)
- Activity questionnaire(1 year)
- glucose concentration in blood(1 year)
- glycosylated haemoglobin (HbA1c) concentration in blood(1 year)
- c-peptide concentration in blood(1 year)
- concentration of triglycerides in blood serum(1 year)
- concentration of total cholesterol in blood(1 year)
- concentration of low density lipid (LDL) cholesterol in blood(1 year)
- concentration of high density lipid (HDL) cholesterol in blood(1 year)
研究者
研究点 (1)
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