Physical Activity Promotion in Children Using a Novel Smartphone Game: A Pilot Randomized Controlled Trial

• ClinicalTrials.gov Identifier: NCT04593199
• Recruitment Status: Recruiting
• First Posted: October 19, 2020
• Last Update Posted: November 5, 2021
• Sponsor: University of Victoria
• Information provided by (Responsible Party): Sam Liu, University of Victoria

Study Description

Brief 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. 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.

Condition or disease	Intervention/treatment	Phase
Physical Activity	Behavioral: Gamified Smartphone App; Behavioral: Physical activity tracking app	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Physical Activity Promotion in Children Using a Novel Smartphone Game: A Pilot Randomized Controlled Trial
• Actual Study Start Date: January 28, 2019
• Estimated Primary Completion Date: March 1, 2022
• Estimated Study Completion Date: April 15, 2022

Arms and Interventions

Arm	Intervention/treatment
Sham Comparator: Physical Activity Tracking App Only; Over a four week period, participants were asked to use the Fitbit app to track their daily physical activity.	Behavioral: Physical activity tracking app; Participants were asked to use the Fitbit app to track and sync their daily physical activity.; Other Name: Fitbit app
Active Comparator: Physical Activity Tracking + Gamified Smartphone App; 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.	Behavioral: Gamified Smartphone 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.; Other Name: Draco app

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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

Secondary Outcome Measures :

1. Steps [ Time Frame: 4 weeks ]
   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).
2. Physical activity minutes [ Time Frame: 4 weeks ]
   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).
3. Motivation for physical activity [ Time Frame: 4 weeks ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 8 Years to 14 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Diagnosis or injury that prevents physical activity participation
• No access to a smartphone or tablet

Contacts and Locations

Contacts

Contact: Sam Liu, PhD; 2507218392; samliu@uvic.ca

Contact: Sam Lapusniak, Masters; 2508094655; samlapusniak@uvic.ca

Locations

Canada, British Columbia

University of Victoria; Recruiting

Victoria, British Columbia, Canada, V8W2Y2

Contact: Sam Liu, PhD 250-721-8392 samliu@uvic.ca

Sponsors and Collaborators

University of Victoria

More Information

• Responsible Party: Sam Liu, Assistant Professor, University of Victoria
• ClinicalTrials.gov Identifier: NCT04593199
• Other Study ID Numbers: UVic181243
• First Posted: October 19, 2020
• Last Update Posted: November 5, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sam Liu, University of Victoria:

Children; Mobile health; Gamification; Physical Activity