Clinical trial NCT04749004: A Randomized-Controlled Lifestyle Intervention to Increase Physical Activity Levels in Adolescents
Official title: Healthy.Tyrol - A Randomized-Controlled Lifestyle Intervention to Increase Physical Activity Levels in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Life Style, Healthy
Life Style
Keywords: Lifestyle Intervention
Adolescents
Health Behavior
Financial Incentives
Commitment Contract
Nudges
Cardiovascular Risk Reduction
Primoridal Prevention
Physical Activity
Lead sponsor: VASCage GmbH
Sponsor class: OTHER
Collaborators: name: Management Center Innsbruck
name: Medical University Innsbruck
name: Tirol Kiniken GmbH
First posted: 2021-02-10
Enrollment: 373
Sex: ALL
Minimum age (years): 14
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in average number of steps taken per day
timeFrame: month 1 versus months 2-7
Secondary outcomes:
measure: Difference in average number of steps taken per day
timeFrame: month 1 versus month 8 to follow-up examination
measure: Achievement of pre-defined goal of steps (specified as percentage change compared to baseline; 0-50% increase)
timeFrame: month 1 versus months 2-7
measure: Difference in number of ideal cardiovascular health metrics in the ideal range as defined by the American Heart Association
timeFrame: 15 months
measure: Difference in average minutes of moderate to vigorous physical activity per day
timeFrame: 15 months
measure: Difference in systolic and diastolic blood pressure
timeFrame: 15 months
measure: Difference in body composition as measured by bioeletrical impedance
timeFrame: 15 months
measure: Magnitude of commitment (specified as as percentage increase of steps taken by steps of 10 percentage points ranging from 0% - 50%)
timeFrame: 15 months
measure: Difference in visceral abdominal fat-tissue thickness as measured by ultrasonography
timeFrame: 15 months
measure: Difference in liver fat and fibrosis as measured by FibroScan
timeFrame: 15 months
measure: Predictors of progression of Intima-Media Thickness [µm]
timeFrame: 15 months
measure: Predictors of progression of pulse-wave velocity [m/s]
timeFrame: 15 months
Other outcomes:
measure: The role of time and risk preferences on long-term habit formation (of physical activity in amount of steps taken).
timeFrame: 15 months
measure: 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
timeFrame: 15 months
measure: The impact of physical activity on primary headache disorders.
timeFrame: 15 months
Locations:
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
state: Tyrol
Study officials:
affiliation: Medical University Innsbruck
name: Michael Knoflach, MD
role: PRINCIPAL_INVESTIGATOR
References: