Physical ActivityNCT03279497
Health Game Intervention to Promote the Physical Activity of Early Adolescents
A study testing Health game and Sport and fitness application in people with Physical Activity and Health Behavior, run by University of Turku at 1 site in Finland.
Trial 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). Read more about this study
- Who is it for?
- Ages 10 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Health Behavior
- What is being tested?
- Health game and Sport and fitness application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteFinland
- Study dates
- Oct 2017to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Physical activity impairments
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Primary schools (n=2)
Turku, Southwest Finland
Anni Pakarinen, +358451213567, anni.pakarinen@utu.fi
About this study
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.
Read the detailed description
The study evaluates the effectiveness of the game-intervention in promotion of physical activity self-efficacy and physical activity behavior among early 10 to 13 years old adolescents. Participants allocated to the Health game intervention group will use a game called Movenator, during a four week intervention and participants allocated to the Sport and fitness-intervention group will use a commercially available Sport and fitness application for running, cycling and every-day training, during a four week intervention period.
- Conditions
- Physical Activity, Health Behavior
- Being tested
- Health game, Sport and fitness application
- Medical subject headings
- Motor Activity, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health gameBehavioural
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.
Sport and fitness applicationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Sport and fitness application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physical activity behavior
Physical activity behavior is tracked with Actigraph wGT3X-BT accelerometer during one week period
Measured: at baseline during one week period and at 4 weeks during one week period
Secondary outcomes (3)
Change in Physical activity self-efficacy
Measured with Physical Activity Self-Efficacy Scale (PASES), a 8-item 5-point Likert-scale.
Measured: At baseline and at 4 weeks
Actual use of the intervention
Actual use of the intervention is tracked with log files
Measured: During the four week intervention
Usability of the intervention
Measured with System Usability Scale (SUS), a 10-item 5-point Likert-scale
Measured: At 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study startOct 2017 (estimated)
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anni Pakarinen, University of Turku
- Investigators
- Anni Pakarinen, MHSc, Principal investigator, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03279497
- Sponsor's protocol ID
- MoveF2017
- Status last verified
- Oct 2017
- First submitted
- 5 Sep 2017
- Last updated
- 26 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Game Intervention to Promote the Physical Activity of Early Adolescents
- ClinicalTrials.gov ID
- NCT03279497
- Acronym / sponsor ID
- MoveF2017
- Conditions
- Physical Activity, Health Behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Study start
- Oct 2017 (estimated)
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 12 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study evaluates the effectiveness of the game-intervention in promotion of physical activity self-efficacy and physical activity behavior among early 10 to 13 years old adolescents. Participants allocated to the Health game intervention group will use a game called Movenator, during a four week intervention and participants allocated to the Sport and fitness-intervention group will use a commercially available Sport and fitness application for running, cycling and every-day training, during a four week intervention period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health game | Experimental | Behavioral: Health gameHealth 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. |
| Sport and fitness application | Sham comparator | Behavioral: Sport and fitness applicationSport 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. |
Who may qualify
- Ages
- 10 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Physical activity impairments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health gameParticipants 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. | Behavioural | Health game |
| Sport and fitness applicationParticipants 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. | Behavioural | Sport and fitness application |
Primary outcome
Change in Physical activity behavior
Time frame: at baseline during one week period and at 4 weeks during one week period
Physical activity behavior is tracked with Actigraph wGT3X-BT accelerometer during one week period
3 secondary outcomes
Change in Physical activity self-efficacy
Time frame: At baseline and at 4 weeks
Actual use of the intervention
Time frame: During the four week intervention
Usability of the intervention
Time frame: At 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anni Pakarinen, MHSc principal investigator
University of Turku
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health game and Sport and fitness application in people with Physical Activity and Health Behavior, run by University of Turku at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anni Pakarinen, MHSc (+358451213567, anni.pakarinen@utu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Physical activity behavior (time frame: at baseline during one week period and at 4 weeks during one week period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2017.