Healthy.Tyrol - A Randomized-Controlled Lifestyle Intervention to Increase Physical Activity Levels in Adolescents
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Life Style, Healthy
- Sponsor
- VASCage GmbH
- Enrollment
- 373
- Locations
- 1
- Primary Endpoint
- Difference in average number of steps taken per day
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 14 - 16 years at baseline
- •Signed informed consent of subjects and legal guardian
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Difference in average number of steps taken per day
Time Frame: month 1 versus months 2-7
Baseline (observation period = first month) versus intervention period (months 2-7)
Secondary Outcomes
- 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)