Life Style, Healthyhealthy tyrolNCT04749004
A Randomized-Controlled Lifestyle Intervention to Increase Physical Activity Levels in Adolescents
A study testing Promotion of physical activity in people with Life Style, Healthy and Life Style, run by VASCage GmbH at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Life Style, Healthy, Life Style
- What is being tested?
- Promotion of physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 373 participants
- Where
- 1 siteAustria
- Study dates
- 23 Sep 2021to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 14 - 16 years at baseline
- Signed informed consent of subjects and legal guardian
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Healthy.Tyrol - A Randomized-Controlled Lifestyle Intervention to Increase Physical Activity Levels in Adolescents
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.
Read the 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.
- Conditions
- Life Style, Healthy, Life Style
- Being tested
- Promotion of physical activity
- Keywords
- Lifestyle Intervention, Adolescents, Health Behavior, Financial Incentives, Commitment Contract, Nudges, Cardiovascular Risk Reduction, Primoridal Prevention, Physical Activity
- Medical subject headings
- Health Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promotion of physical activityBehavioural
Provision of motivational stimuli (commitment contracts, nudges, financial incentives) to increase amount of steps taken
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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) Receives: Behavioral: Promotion of physical activity |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in average number of steps taken per day
Baseline (observation period = first month) versus intervention period (months 2-7)
Measured: month 1 versus months 2-7
Secondary outcomes (11)
Difference in average number of steps taken per day
Baseline (observation period = first month) versus post-intervention period (month 8 - follow-up examination)
Measured: 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)
percentage of participants in the intervention group achieving their predefined goal (using explanatory variables such as demographic variables, time and risk preferences etc.
Measured: month 1 versus months 2-7
Difference in number of ideal cardiovascular health metrics in the ideal range as defined by the American Heart Association
Between and within group differences
Measured: 15 months
Difference in average minutes of moderate to vigorous physical activity per day
Between and within group differences
Measured: 15 months
Difference in systolic and diastolic blood pressure
Between and within group differences
Measured: 15 months
Difference in body composition as measured by bioeletrical impedance
Between and within group differences
Measured: 15 months
Magnitude of commitment (specified as as percentage increase of steps taken by steps of 10 percentage points ranging from 0% - 50%)
Between group differences
Measured: 15 months
Difference in visceral abdominal fat-tissue thickness as measured by ultrasonography
Between and within group differences
Measured: 15 months
Difference in liver fat and fibrosis as measured by FibroScan
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].
Measured: 15 months
Predictors of progression of Intima-Media Thickness [µm]
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.
Measured: 15 months
Predictors of progression of pulse-wave velocity [m/s]
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.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start23 Sep 2021
- Primary completion28 Feb 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Life Style, HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 373 participants (actual)
Sponsor and investigators
- Lead sponsor
- VASCage GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Management Center Innsbruck, Medical University Innsbruck, Tirol Kiniken GmbH
- Responsible party
- Sponsor
- Investigators
- Michael Knoflach, MD, Principal investigator, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04749004
- Sponsor's protocol ID
- healthy.tyrol
- Acronym
- healthy tyrol
- Status last verified
- May 2023
- First submitted
- 23 Sep 2020
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy.Tyrol - A Randomized-Controlled Lifestyle Intervention to Increase Physical Activity Levels in Adolescents
- ClinicalTrials.gov ID
- NCT04749004
- Acronym / sponsor ID
- healthy tyrol / healthy.tyrol
- Conditions
- Life Style, Healthy, Life Style
- Keywords
- Lifestyle Intervention, Adolescents, Health Behavior, Financial Incentives, Commitment Contract, Nudges, Cardiovascular Risk Reduction, Primoridal Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 373 participants (actual)
- Lead sponsor
- VASCage GmbHUniversity, hospital or other
- Collaborators
- Management Center Innsbruck, Medical University Innsbruck, Tirol Kiniken GmbH
- Study start
- 23 Sep 2021 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Promotion of physical activityTracking 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) |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 14 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age 14 - 16 years at baseline
- Signed informed consent of subjects and legal guardian
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Promotion of physical activityProvision of motivational stimuli (commitment contracts, nudges, financial incentives) to increase amount of steps taken | Behavioural | Intervention Group |
Primary outcome
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)
11 secondary outcomes
Difference in average number of steps taken per day
Time frame: 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)
Time frame: month 1 versus months 2-7
Difference in number of ideal cardiovascular health metrics in the ideal range as defined by the American Heart Association
Time frame: 15 months
Difference in average minutes of moderate to vigorous physical activity per day
Time frame: 15 months
Difference in systolic and diastolic blood pressure
Time frame: 15 months
Difference in body composition as measured by bioeletrical impedance
Time frame: 15 months
Magnitude of commitment (specified as as percentage increase of steps taken by steps of 10 percentage points ranging from 0% - 50%)
Time frame: 15 months
Difference in visceral abdominal fat-tissue thickness as measured by ultrasonography
Time frame: 15 months
Difference in liver fat and fibrosis as measured by FibroScan
Time frame: 15 months
Predictors of progression of Intima-Media Thickness [µm]
Time frame: 15 months
Predictors of progression of pulse-wave velocity [m/s]
Time frame: 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Knoflach, MD principal investigator
Medical University Innsbruck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Promotion of physical activity in people with Life Style, Healthy and Life Style, run by VASCage GmbH at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in average number of steps taken per day (time frame: month 1 versus months 2-7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.