Healthy.Tyrol - A Randomized-Controlled Lifestyle Intervention to Increase Physical Activity Levels in Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- VASCage GmbH
- 入组人数
- 373
- 试验地点
- 1
- 主要终点
- Difference in average number of steps taken per day
研究概览
简要总结
Students at the age of 14-16 years will be randomized to one intervention arm or one control arm in a 1:1 ratio. Participants of both groups receive a fitness tracker to count the amount of their steps taken. The participants of the intervention arm will commit themselves to a personal goal of steps taken by means of a commitment contract. Achievement of the goal will be rewarded with financial incentives to fulfill the requirements of proper reward medium, according to the Induced Value Theory (Smith, 1976).
The duration of the intervention will be 1 year; incentives are provided for 6 months, the remaining 6 months are the follow-up period.
The hypothesis is that intensified motivational strategies like the provision of commitment contracts and nudges are effective in increasing the number of steps taken per month compared to a control group.
详细描述
Adolescents age 14 to 16 years visiting schools throughout Tyrol, Austria will be randomized to one intervention arm or a control arm on a class-wise level in a 1:1 ratio. Participants will be invited by the Department of Education in Tyrol and schools will be contacted directly. At the baseline examination cardiovascular risk profiles (including laboratory analysis; anthropometry; a standardized medical interview; and blood pressure, bioelectrical impedance and pulse-wave velocity measurements) are determined and results are communicated in an individual discussion of results.
Afterwards, participants of both groups receive a fitness tracker to count the amount of their steps taken. The participants of the intervention arm will commit themselves to a personal goal of steps taken by means of a commitment contract. Achievement of the goal will be rewarded with financial incentives to fulfill the requirements of proper reward medium, according to the Induced Value Theory (Smith, 1976) and nudges (reminders) will be provided to increase motivation.
The duration of the intervention will be 1 year; incentives are provided for 6 months, the remaining 6 months are the follow-up period. After 1 year a follow-up examination will be conducted. Economic experiments on time and risk preferences are furthermore carried out at baseline.
The hypothesis is that intensified motivational strategies like the provision of commitment contracts and nudges are effective in increasing the number of steps taken per month compared to a control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 14 - 16 years at baseline
- •Signed informed consent of subjects and legal guardian
排除标准
- •Persons, who are suspended upon a court order or upon other legal processes or are accommodated according to the Hospitalization Act, or for whom a custodian is appointed (or appointment is initiated).
- •Persons with impaired power of judgment
- •Persons who are currently engaged in military or community service
研究组 & 干预措施
Intervention Group
Tracking of steps by means of a fitness tracker
For the economic experiments on time and risk preferences monetary rewards are used with the amount depending on the decisions of the participants.
Participants collect points for transmitting informations about the amount of steps taken on the basis of which they get a small reward (e.g., a skiing ticket)
Setting-up of a commitment contract on the individual's goal of monthly steps taken
Provision of financial incentives upon achievement of one's goal of steps taken
Provision of nudges (reminders)
干预措施: Promotion of physical activity (Behavioral)
Control Group
Tracking of steps by means of a fitness tracker
For the economic experiments on time and risk preferences monetary rewards are used with the amount depending on the decisions of the participants.
Participants collect points for transmitting informations about the amount of steps taken on the basis of which they get a small reward (e.g., a skiing ticket)
To keep incentives constant the control group will also receive the flat payment of €10 to disentangle the effects between the contract and financial incentives.
结局指标
主要结局
Difference in average number of steps taken per day
时间窗: month 1 versus months 2-7
Baseline (observation period = first month) versus intervention period (months 2-7)
次要结局
- Difference in number of ideal cardiovascular health metrics in the ideal range as defined by the American Heart Association(15 months)
- Difference in visceral abdominal fat-tissue thickness as measured by ultrasonography(15 months)
- Predictors of progression of Intima-Media Thickness [µm](15 months)
- Difference in average minutes of moderate to vigorous physical activity per day(15 months)
- Magnitude of commitment (specified as as percentage increase of steps taken by steps of 10 percentage points ranging from 0% - 50%)(15 months)
- Predictors of progression of pulse-wave velocity [m/s](15 months)
- Difference in systolic and diastolic blood pressure(15 months)
- Difference in body composition as measured by bioeletrical impedance(15 months)
- Difference in average number of steps taken per day(month 1 versus month 8 to follow-up examination)
- Achievement of pre-defined goal of steps (specified as percentage change compared to baseline; 0-50% increase)(month 1 versus months 2-7)
- Difference in liver fat and fibrosis as measured by FibroScan(15 months)