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

Life Style Clinical Trial

— healthy tyrol  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04749004
• Other study ID #: healthy.tyrol
• Status: Completed
• Phase: N/A
• Start date: September 23, 2021
• Est. completion date: March 31, 2023

Study information

• Verified date: May 2023
• Source: VASCage GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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 information / eligibility

• Status: Completed
• Enrollment: 373
• Est. completion date: March 31, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Life Style
• Life Style, Healthy

Intervention

Behavioral:
• Promotion of physical activity
Provision of motivational stimuli (commitment contracts, nudges, financial incentives) to increase amount of steps taken

Locations

Country	Name	City	State
Austria	Medical University Innsbruck	Innsbruck	Tyrol

Sponsors (4)

Lead Sponsor	Collaborator
VASCage GmbH	Management Center Innsbruck, Medical University Innsbruck, Tirol Kiniken GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Difference in average minutes of moderate to vigorous physical activity per day	Between and within group differences	15 months
Secondary	Difference in systolic and diastolic blood pressure	Between and within group differences	15 months
Secondary	Difference in body composition as measured by bioeletrical impedance	Between and within group differences	15 months
Secondary	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
Secondary	Difference in visceral abdominal fat-tissue thickness as measured by ultrasonography	Between and within group differences	15 months
Secondary	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
Secondary	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
Secondary	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