NCT03279497

Brief Summary

The study evaluates the effectiveness of the game-intervention in promotion of physical activity self-efficacy and physical activity behavior among early adolescents (10-13 year olds). Half of the study participants will receive the game-intervention and half of the study participants will receive a commercially available sport and fitness application for running, cycling and every-day training.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 12, 2017

Completed
19 days until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

3 months

First QC Date

September 5, 2017

Last Update Submit

October 24, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Physical activity behavior

    Physical activity behavior is tracked with Actigraph wGT3X-BT accelerometer during one week period

    at baseline during one week period and at 4 weeks during one week period

Secondary Outcomes (3)

  • Change in Physical activity self-efficacy

    At baseline and at 4 weeks

  • Actual use of the intervention

    During the four week intervention

  • Usability of the intervention

    At 4 weeks

Study Arms (2)

Health game

EXPERIMENTAL

Health game intervention consists of 20 minutes guided training session with the mobile health game at school and 4 weeks free usage of the game via own smart phone during free time. Smart phones are tracking the actual physical activity (steps) of the participants via activity sensors and the tracked steps work as In-App Currency enabling the participants to play the game and proceed in it.

Behavioral: Health game

Sport and fitness application

SHAM COMPARATOR

Sport and fitness application intervention consists of 20 minutes guided training session with the app at school and 4 weeks free usage of the app via own smart phone during free time. Sport and fitness application, when turned on, tracks the physical activity (running, cycling and every-day training) of the participant.

Behavioral: Sport and fitness application

Interventions

Health gameBEHAVIORAL

Participants allocated to the Health game intervention group get to use the health game during the four week intervention period and participants are allowed to use it on their free time.

Health game

Participants allocated to the Sport and fitness application intervention group get to use the sport and fitness application during the four week intervention period and participants are allowed to use it on their free time.

Sport and fitness application

Eligibility Criteria

Age10 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Goes to school at 4th, 5th or 6th grade
  • Understands and can communicate either in Finnish
  • Has daily access to a smart phone (Android) during free time

You may not qualify if:

  • Physical activity impairments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Primary schools (n=2)

Turku, Southwest Finland, Finland

RECRUITING

MeSH Terms

Conditions

Motor ActivityHealth Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Anni Pakarinen, MHSc

    University of Turku

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anni Pakarinen, MHSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral candidate

Study Record Dates

First Submitted

September 5, 2017

First Posted

September 12, 2017

Study Start

October 1, 2017

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

October 26, 2017

Record last verified: 2017-10

Locations