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

NCT04749004 | Completed

• 1 other identifier: healthy.tyrol
• Study Type: interventional
• Target: 373
• Locations: 1 country
• Sites: 1

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.

Conditions

Life Style, Healthy; Life Style

Keywords

Lifestyle Intervention; Adolescents; Health Behavior; Financial Incentives; Commitment Contract; Nudges; Cardiovascular Risk Reduction; Primoridal Prevention; Physical Activity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Difference in average number of steps taken per day

  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)

  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

  15 months

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

  15 months

• Difference in systolic and diastolic blood pressure

  15 months

Other Outcomes (3)

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

  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

  15 months

• The impact of physical activity on primary headache disorders.

  15 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

Promotion of physical activity BEHAVIORAL

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

Intervention Group

Eligibility Criteria

• Age: 14 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 14 - 16 years at baseline
• Signed informed consent of subjects and legal guardian

You may not qualify if:

• 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

Sponsors & Collaborators

• VASCage GmbH: lead
• Management Center Innsbruck: collaborator
• Medical University Innsbruck: collaborator
• Tirol Kiniken GmbH: collaborator

Study Sites (1)

Medical University Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

MeSH Terms

Conditions

Health Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Michael Knoflach, MD

  Medical University Innsbruck

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: February 10, 2021
• Study Start: September 23, 2021
• Primary Completion: February 28, 2023
• Study Completion: March 31, 2023
• Last Updated: May 17, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)