A Randomized-Controlled Lifestyle Intervention to Increase Physical Activity Levels in Adolescents
- Conditions
- Life StyleLife Style, Healthy
- Interventions
- Behavioral: Promotion of physical activity
- Registration Number
- NCT04749004
- Lead Sponsor
- VASCage GmbH
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 373
- Age 14 - 16 years at baseline
- Signed informed consent of subjects and legal guardian
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Group Promotion of physical activity 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)
- Primary Outcome Measures
Name Time Method Difference in average number of steps taken per day month 1 versus months 2-7 Baseline (observation period = first month) versus intervention period (months 2-7)
- Secondary Outcome Measures
Name Time Method Difference in number of ideal cardiovascular health metrics in the ideal range as defined by the American Heart Association 15 months Between and within group differences
Difference in visceral abdominal fat-tissue thickness as measured by ultrasonography 15 months Between and within group differences
Predictors of progression of Intima-Media Thickness [µm] 15 months Intima-media thickness is assessed by means of ultrasonography, predictors to be examined include: Blood pressure, lipid parameters, age, sex, liver fat and fibrosis, body composition/BMI, smoking, fasting glucose and CRP.
Difference in average minutes of moderate to vigorous physical activity per day 15 months Between and within group differences
Magnitude of commitment (specified as as percentage increase of steps taken by steps of 10 percentage points ranging from 0% - 50%) 15 months Between group differences
Predictors of progression of pulse-wave velocity [m/s] 15 months pulse-wave velocity is measured using the Vicorder, an oscillometric pulse-wave velocity measurement device, predictors to be examined include: Blood pressure, lipid parameters, age, sex, liver fat and fibrosis, body composition/BMI, smoking, fasting glucose and CRP.
Difference in systolic and diastolic blood pressure 15 months Between and within group differences
Difference in body composition as measured by bioeletrical impedance 15 months Between and within group differences
Difference in average number of steps taken per day month 1 versus month 8 to follow-up examination Baseline (observation period = first month) versus post-intervention period (month 8 - 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 percentage of participants in the intervention group achieving their predefined goal (using explanatory variables such as demographic variables, time and risk preferences etc.
Difference in liver fat and fibrosis as measured by FibroScan 15 months Between and within group differences Liver fat content is assessed by means of the Controlled-Attenuation Parameter \[dB/m\] and fibrosis by means of transient elastography \[kPa\].
Trial Locations
- Locations (1)
Medical University Innsbruck
🇦🇹Innsbruck, Tyrol, Austria