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A Randomized-Controlled Lifestyle Intervention to Increase Physical Activity Levels in Adolescents

Healthy.Tyrol - A Randomized-Controlled Lifestyle Intervention to Increase Physical Activity Levels in Adolescents

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04749004
Acronym
healthy tyrol
Enrollment
373
Registered
2021-02-10
Start date
2021-09-23
Completion date
2023-03-31
Last updated
2023-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Life Style, Life Style, Healthy

Keywords

Lifestyle Intervention, Adolescents, Health Behavior, Financial Incentives, Commitment Contract, Nudges, Cardiovascular Risk Reduction, Primoridal Prevention, Physical Activity

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.

Interventions

Provision of motivational stimuli (commitment contracts, nudges, financial incentives) to increase amount of steps taken

Sponsors

Management Center Innsbruck
CollaboratorUNKNOWN
Medical University Innsbruck
CollaboratorOTHER
Tirol Kiniken GmbH
CollaboratorOTHER
VASCage GmbH
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
14 Years to 16 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Difference in average number of steps taken per daymonth 1 versus months 2-7Baseline (observation period = first month) versus intervention period (months 2-7)

Secondary

MeasureTime frameDescription
Difference in average minutes of moderate to vigorous physical activity per day15 monthsBetween and within group differences
Difference in liver fat and fibrosis as measured by FibroScan15 monthsBetween 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 \[kPa\].
Predictors of progression of Intima-Media Thickness [µm]15 monthsIntima-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.
Predictors of progression of pulse-wave velocity [m/s]15 monthspulse-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.
Magnitude of commitment (specified as as percentage increase of steps taken by steps of 10 percentage points ranging from 0% - 50%)15 monthsBetween group differences
Difference in visceral abdominal fat-tissue thickness as measured by ultrasonography15 monthsBetween and within group differences
Achievement of pre-defined goal of steps (specified as percentage change compared to baseline; 0-50% increase)month 1 versus months 2-7percentage of participants in the intervention group achieving their predefined goal (using explanatory variables such as demographic variables, time and risk preferences etc.
Difference in number of ideal cardiovascular health metrics in the ideal range as defined by the American Heart Association15 monthsBetween and within group differences
Difference in systolic and diastolic blood pressure15 monthsBetween and within group differences
Difference in body composition as measured by bioeletrical impedance15 monthsBetween and within group differences
Difference in average number of steps taken per daymonth 1 versus month 8 to follow-up examinationBaseline (observation period = first month) versus post-intervention period (month 8 - follow-up examination)

Other

MeasureTime frameDescription
The impact of physical activity on primary headache disorders.15 monthsPhysical acitivity is assessed by means of a fitness tracker (with step counting function) and by structured physician-guided interviews. Primary headache disorders are assessed in structured physician-guided interviews and classified according to the ICHD-3. Parameters include frequency, intensity, duration, headache characteristics and concomitant symptoms.
The role of time and risk preferences on long-term habit formation (of physical activity in amount of steps taken).15 monthsTime and risk preferences are assessed by means of economic experiments specific for each preference, steps taken are assessed by means of a fitness tracker/step counter.
The role of time and risk preferences on the change of the amount of steps taken per day every month during the motivation period and afterwards in comparison to the baseline value at month 115 monthsTime and risk preferences are assessed by means of economic experiments specific for each preference, steps taken are assessed by means of a fitness tracker/step counter.

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026