A Randomized-Controlled Lifestyle Intervention to Increase Physical Activity Levels in Adolescents (healthy tyrol)

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.

Study Overview

• Status: Completed
• Conditions: Life Style, Healthy; Life Style
• Intervention / Treatment: Behavioral: Promotion of physical activity

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 Type: Interventional
• Enrollment (Actual): 373
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Tyrol
    • Innsbruck, Tyrol, Austria, 6020
      • Medical University Innsbruck

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 16 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; 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)	Behavioral: Promotion of physical activity; Provision of motivational stimuli (commitment contracts, nudges, financial incentives) to increase amount of steps taken
No Intervention: Control Group; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in average number of steps taken per day	Baseline (observation period = first month) versus intervention period (months 2-7)	month 1 versus months 2-7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in average number of steps taken per day	Baseline (observation period = first month) versus post-intervention period (month 8 - follow-up examination)	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.	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	15 months
Difference in average minutes of moderate to vigorous physical activity per day	Between and within group differences	15 months
Difference in systolic and diastolic blood pressure	Between and within group differences	15 months
Difference in body composition as measured by bioeletrical impedance	Between and within group differences	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	15 months
Difference in visceral abdominal fat-tissue thickness as measured by ultrasonography	Between and within group differences	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].	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.	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.	15 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The role of time and risk preferences on long-term habit formation (of physical activity in amount of steps taken).	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.	15 months
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 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.	15 months
The impact of physical activity on primary headache disorders.	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.	15 months

Collaborators and Investigators

• Sponsor: VASCage GmbH
• Collaborators: Medical University Innsbruck; Tirol Kiniken GmbH; Management Center Innsbruck
• Investigators: Principal Investigator: Michael Knoflach, MD, Medical University Innsbruck

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2021
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: September 23, 2020
• First Submitted That Met QC Criteria: February 5, 2021
• First Posted (Actual): February 10, 2021

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Adolescents; Physical Activity; Lifestyle Intervention; Health Behavior; Financial Incentives; Commitment Contract; Nudges; Cardiovascular Risk Reduction; Primoridal Prevention
• Other Study ID Numbers: healthy.tyrol

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No