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

NCT ID: NCT04749004

Last Updated: 2023-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 373 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-23
• Study Completion Date: 2023-03-31

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.

Conditions

Life Style, Healthy; Life Style

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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)

Group Type: EXPERIMENTAL

Promotion of physical activity

Intervention Type: BEHAVIORAL

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Promotion of physical activity

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Management Center Innsbruck

UNKNOWN

Sponsor Role: collaborator

Medical University Innsbruck

OTHER

Sponsor Role: collaborator

Tirol Kiniken GmbH

OTHER

Sponsor Role: collaborator

VASCage GmbH

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Knoflach, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University Innsbruck

Locations

Medical University Innsbruck

Innsbruck, Tyrol, Austria

Countries

Austria

Other Identifiers

healthy.tyrol

Identifier Type: -

Identifier Source: org_study_id