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Completed

NCT Number: NCT04749004

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.

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Key information

Conditions

Life Style, Healthy Behavior Health Behavior Life Style Motor Activity

Age range

14 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University Innsbruck

Innsbruck, Tyrol, 6020, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Promotion of physical activity

Behavioral

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

Primary outcomes

  1. 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

  1. Difference in average number of steps taken per day

    Time frame: month 1 versus month 8 to follow-up examination

    Baseline (observation period = first month) versus post-intervention period (month 8 - follow-up examination)

  2. 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

    percentage of participants in the intervention group achieving their predefined goal (using explanatory variables such as demographic variables, time and risk preferences etc.

  3. Difference in number of ideal cardiovascular health metrics in the ideal range as defined by the American Heart Association

    Time frame: 15 months

    Between and within group differences

  4. Difference in average minutes of moderate to vigorous physical activity per day

    Time frame: 15 months

    Between and within group differences

  5. Difference in systolic and diastolic blood pressure

    Time frame: 15 months

    Between and within group differences

  6. Difference in body composition as measured by bioeletrical impedance

    Time frame: 15 months

    Between and within group differences

  7. 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

    Between group differences

  8. Difference in visceral abdominal fat-tissue thickness as measured by ultrasonography

    Time frame: 15 months

    Between and within group differences

  9. Difference in liver fat and fibrosis as measured by FibroScan

    Time frame: 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].

  10. Predictors of progression of Intima-Media Thickness [µm]

    Time frame: 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.

  11. Predictors of progression of pulse-wave velocity [m/s]

    Time frame: 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.

Other outcomes

  1. The role of time and risk preferences on long-term habit formation (of physical activity in amount of steps taken).

    Time frame: 15 months

    Time 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.

  2. 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 1

    Time frame: 15 months

    Time 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.

  3. The impact of physical activity on primary headache disorders.

    Time frame: 15 months

    Physical 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.

Sponsors and collaborators

Lead sponsor

VASCage GmbH

Other

Collaborators

  • Management Center Innsbruck
  • Medical University Innsbruck
  • Tirol Kiniken GmbH

Registry information

Official study title

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

Acronym: healthy tyrol

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 10, 2021
Registry last updated
May 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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