Physical ActivityNCT04593199
Physical Activity Promotion in Children Using a Novel Smartphone Game: A Pilot Randomized Controlled Trial
A study testing Gamified Smartphone App and Physical activity tracking app in people with Physical Activity, run by University of Victoria at 1 site in Canada.
Trial summary
Increasing physical activity is critical for children's overall health. Smartphone apps using gamification has shown promise to increasing physical activity using game techniques. Read more about this study
- Who is it for?
- Ages 8 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Gamified Smartphone App and Physical activity tracking app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteCanada
- Study dates
- 28 Jan 2019to 15 Apr 2022
- 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 8 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 8-14 years old
- Not meeting the recommended Canadian physical activity guidelines of 60min per day of moderate-to-vigorous physical activity
- English-literate
- Normal to corrected vision
Who cannot join
- Diagnosis or injury that prevents physical activity participation
- No access to a smartphone or tablet
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of Victoria
Victoria, British Columbia, V8W2Y2
Sam Liu, PhD, 250-721-8392, samliu@uvic.ca
About this study
Increasing physical activity is critical for children's overall health. Smartphone apps using gamification has shown promise to increasing physical activity using game techniques. This study is a 4-week randomized controlled trial using a gamified smartphone app to determine acceptability and preliminary effectiveness to increase physical activity in children.
- Conditions
- Physical Activity
- Being tested
- Gamified Smartphone App, Physical activity tracking app
- Keywords
- Children, Mobile health, Gamification, Physical Activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamified Smartphone AppBehavioural
Also called Draco app
The primary objective was to determine the acceptability and satisfaction of the Draco app among children. Secondary objective was to evaluate if the Draco app could improve physical activity levels (steps, and moderate-to-vigorous physical activity) and intrinsic motivation for physical activity in children. The gamified smartphone app, Draco, is a virtual pet simulator where you care for a pet by exercising, walking, and answering healthy lifestyle questions.
Physical activity tracking appBehavioural
Also called Fitbit app
Participants were asked to use the Fitbit app to track and sync their daily physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity Tracking App Only | Sham comparator | Over a four week period, participants were asked to use the Fitbit app to track their daily physical activity. Receives: Behavioral: Physical activity tracking app |
| Physical Activity Tracking + Gamified Smartphone App | Active comparator | Over a four week period, participants were asked to use the Fitbit app to track their daily physical activity. Additionally, they were asked to use the gamified smartphone app, Draco, during the intervention period. Receives: Behavioral: Gamified Smartphone App |
What is being measured
The primary outcome is the main question the study is designed to answer.
User satisfaction with gamified smartphone app
User satisfaction was measured using an adapted version of the short form Intrinsic Motivation Inventory used by Ahn, Johnsen \& Ball, 2019. Items pertained to the enjoyment, satisfaction of using the app and if the experience was unenjoyable. Scores are rated on a 5 point Likert scale where 1 is the lowest score and 5 is the highest. 1 = Not true for me; 2 = Not really true for me; 3 = Sometimes true for me; 4 = Often true for me; 5 = Very true for me.
Measured: 4 weeks
Acceptability with gamified smartphone app
Exit interviews were performed after the intervention period to determine satisfaction and acceptability. Questions related to their experience using the app, their physical activity behavior (before, during, and after the intervention period) and recommendations for app content
Measured: 4 weeks
Secondary outcomes (3)
Steps
Steps were collected using a Fitbit over the intervention period. Fitbit is a previously validated and reliable instrument to measure physical activity (Feehan et al., 2018).
Measured: 4 weeks
Physical activity minutes
Minutes of physical activity engaged in by the participants were collected using a Fitbit device worn by participants. The device is worn while the participant is engaging in physical activity. The intensity of exercise is calculated by heartrate. Fitbit is a previously validated and reliable instrument to measure physical activity (Feehan et al., 2018).
Measured: 4 weeks
Motivation for physical activity
Motivation for physical activity was measured using an adapted version of the Intrinsic Motivation Inventory used by Ahn, Johnsen \& Ball, 2019. Questions related to perceived competence to physical activity, perceived autonomy to physical activity and perceived relatedness to the app. The items addressed perceived competence, perceived autonomy, and relatedness. Scores are rated on a 5 point Likert scale where 1 is the lowest score and 5 is the highest. 1 = Not true for me; 2 = Not really true for me; 3 = Sometimes true for me; 4 = Often true for me; 5 = Very true for me.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start28 Jan 2019
- Primary completion1 Mar 2022 (estimated)
- Study completion15 Apr 2022 (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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Victoria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sam Liu, University of Victoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593199
- Sponsor's protocol ID
- UVic181243
- Status last verified
- Oct 2021
- First submitted
- 13 Oct 2020
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity Promotion in Children Using a Novel Smartphone Game: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04593199
- Acronym / sponsor ID
- UVic181243
- Conditions
- Physical Activity
- Keywords
- Children, Mobile health, Gamification, Physical Activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of VictoriaUniversity, hospital or other
- Study start
- 28 Jan 2019 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 15 Apr 2022 (estimated)
- First posted
- 19 Oct 2020 (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.
Increasing physical activity is critical for children's overall health. Smartphone apps using gamification has shown promise to increasing physical activity using game techniques. This study is a 4-week randomized controlled trial using a gamified smartphone app to determine acceptability and preliminary effectiveness to increase physical activity in children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity Tracking App Only | Sham comparator | Behavioral: Physical activity tracking appOver a four week period, participants were asked to use the Fitbit app to track their daily physical activity. |
| Physical Activity Tracking + Gamified Smartphone App | Active comparator | Behavioral: Gamified Smartphone AppOver a four week period, participants were asked to use the Fitbit app to track their daily physical activity. Additionally, they were asked to use the gamified smartphone app, Draco, during the intervention period. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 8-14 years old
- Not meeting the recommended Canadian physical activity guidelines of 60min per day of moderate-to-vigorous physical activity
- English-literate
- Normal to corrected vision
Key exclusion criteria (2 listed)
- Diagnosis or injury that prevents physical activity participation
- No access to a smartphone or tablet
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 |
|---|---|---|
| Gamified Smartphone AppAlso: Draco appThe primary objective was to determine the acceptability and satisfaction of the Draco app among children. Secondary objective was to evaluate if the Draco app could improve physical activity levels (steps, and moderate-to-vigorous physical activity) and intrinsic motivation for physical activity in children. The gamified smartphone app, Draco, is a virtual pet simulator where you care for a pet by exercising, walking, and answering healthy lifestyle questions. | Behavioural | Physical Activity Tracking + Gamified Smartphone App |
| Physical activity tracking appAlso: Fitbit appParticipants were asked to use the Fitbit app to track and sync their daily physical activity. | Behavioural | Physical Activity Tracking App Only |
Primary outcome
User satisfaction with gamified smartphone app
Time frame: 4 weeks
User satisfaction was measured using an adapted version of the short form Intrinsic Motivation Inventory used by Ahn, Johnsen \& Ball, 2019. Items pertained to the enjoyment, satisfaction of using the app and if the experience was unenjoyable. Scores are rated on a 5 point Likert scale where 1 is the lowest score and 5 is the highest. 1 = Not true for me; 2 = Not really true for me; 3 = Sometimes true for me; 4 = Often true for me; 5 = Very true for me.
Acceptability with gamified smartphone app
Time frame: 4 weeks
Exit interviews were performed after the intervention period to determine satisfaction and acceptability. Questions related to their experience using the app, their physical activity behavior (before, during, and after the intervention period) and recommendations for app content
3 secondary outcomes
Steps
Time frame: 4 weeks
Physical activity minutes
Time frame: 4 weeks
Motivation for physical activity
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gamified Smartphone App and Physical activity tracking app in people with Physical Activity, run by University of Victoria at 1 site in Canada.
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 4 inclusion and 2 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 5 Nov 2021. 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 Canada. 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 Sam Liu, PhD (2507218392, samliu@uvic.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
User satisfaction with gamified smartphone app (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 5 Nov 2021.