Physical ActivityNCT02032667
Exercise Games and Physical Activity: Can a Home-based Exergame System Increase Physical Activity?
A study testing Multi-player condition in people with Physical Activity, run by University of Victoria at 2 sites in Canada.
Trial summary
This study will be investigating an innovative and exciting way to increase physical activity in children between the ages of 9 and 12 years old. Families will be provided with a state-of-the-art exercise bike and video game console to have in their homes. Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Multi-player condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesCanada
- Study dates
- Sep 2013to Jan 2015
- 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 9 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participants will be children between the ages of 9 and 12 years old from the greater Victoria, B.C. area and Kingston, Ontario region. Children will be included if they participate in physical activity below Canadian recommended guidelines (for children under 60 minutes of activity daily).
- Participants must also pass the physical activity readiness protocol or seek physician clearance before participation.
- The families must also agree to having the exergaming station in an accessible location in their homes for the duration of the trial
- Will need high speed internet
Who cannot join
- Children outside of the ages of 9 - 12 years
- Children who are active greater than recommended guidelines (more than 60 minutes of daily activity)
- Children with special needs (i.e. autism spectrum disorder, ADHD/ADD)
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Queens University
Kingston, Ontario, K7L 3X5
University of Victoria
Victoria, British Columbia, STN-CSC
About this study
Official title: Exercise Games and Physical Activity: Does Multi-player Online Play Improve Adherence?
This study will be investigating an innovative and exciting way to increase physical activity in children between the ages of 9 and 12 years old. Families will be provided with a state-of-the-art exercise bike and video game console to have in their homes. The video games will provide a variety of play including racing, puzzle solving, collaborative play, team play and competitive play. We will be comparing whether a 'multi-player' condition has a greater adherence compared to a 'single-player' condition.
Read the detailed description
- Aims of the study: In 2005, the number of deaths attributed to cancer surpassed those caused by major cardiovascular diseases as the number one cause of mortality in Canada, and to this date, continues to significantly impact the lives of Canadians. As a response to the societal and individual afflictions from disease, it is imperative that research initiatives become more focused in the area of primary prevention. Reports have shown that at least half of all new cancer cases and deaths worldwide can be prevented. The largest impact on cancer development are lifestyle variables such as physical activity. Reviews and meta-analysis show a strong inverse linear relationship between physical activity and many of the most prevalent forms of cancer including breast, lung, and colon cancer (i.e., the more an individual exercises the less likely they are to develop cancer). Unfortunately, over 80% of the Canadian populace fails to meet these recommendations. To compound the problem of low physical activity prevalence, the largest declines in activity may occur early in life. Obviously, regular life-long physical activity is the desired outcome for lowering the risk of cancer; thus, promotion efforts targeting critical transitions to physical inactivity early in life are paramount. Two such groups are parents and their children, making family-based physical activity initiatives arguably the most important target for disease prevention. Unfortunately, physical activity interventions focused on the family home are limited and have resulted in negligible changes in physical activity for both children and their parents. Improvements are required in terms of the innovations of interventions. An area often overlooked when trying to increase physical participation is affective expectations or judgments (expected pleasure and enjoyment). Affective judgments are a central construct - in some form - in many of our popular health behaviour models, yet few interventions have focused on the modification of affective expectations, despite its reliable and robust association with physical activity. One such group of activities with this potential is interactive exercise videogaming (exergames). Exergaming is a relatively unexplored topic but early results and commentary have been very controversial; the topic has generated as many reviews as it has experimental trials. Overall, the emerging evidence suggests that these games can significantly increase energy expenditure similar to moderate intensity physical activities and these can translate into health-related fitness improvements. The research conducted from our group on this topic also shows this finding. Our studies employ exergames within the context of traditional exercise bikes (i.e., exercise bikes that interact with video games) because they demonstrate physical activity in the moderate to vigorous intensity range that results in marked fitness changes. Despite these positive effects, limited research is available to understand adherence to exergames. Further, of the available literature on exergames and exercise adherence, reviews find that the exergame conditions typically report higher adherence than various control conditions but long-term change is negligible or advantages diminish across time. Our research on the topic mirrors these overall conclusions. For example, in our family-based home pilot study of Game-bike, we showed significantly higher enjoyment and use for children in the exergame condition compared to a control bike across six weeks, yet the prominent differences were within the first three weeks and these were sharply declining in the later weeks. Thus, exergaming research that attempts to foster maintenance is needed to demonstrate that the initial high participation rate can be sustained within the context of the family home. This was the key recommendation from recent systematic reviews of exergames and it forms the rationale for the innovation in this proposal. Videogames, similar to these initial exergame results, show decline in playing frequency as games become familiar and the novelty wears. One of the most successful forms of videogaming has been the advent of synchronous multi-player online gaming. Games such as Blizzard's World of Warcraft are played online by millions of people. Specifically, videogames can been played with others online. Gamers may form online social clubs (teams, leagues or "guilds") allowing them to play regularly with the same group of people. The social attachments formed by players can be as strong as those held in the "physical" world, contributing to an extremely long maintenance playtime in comparison to ordinary gaming. To our knowledge, exergames with these properties have not been examined with families in the home. Nevertheless, there is an extensive body of research on the effects of social contexts in supporting physical activity adherence behaviour that suggest that people are more likely to sustain their involvement in a physical activity setting if they participate in social, or group-based, settings rather than on their own. In the context of this trial, if Canadian youth are provided with the opportunity to be part of a virtual group (through online synchronous game play), this will likely support their sense of social connectedness in relation to other youth in that condition, a greater degree of enjoyment of the intervention (affective judgements), and thereafter sustain their adherence behaviours. Thus, the primary research question: Does an interactive exergame bike augmented by synchronous online social play capability in comparison to 2) an exergame bike condition both within a family home environment result in greater use among children? Hypothesis: Adherence will be higher for the augmented exergame condition in comparison to the standard exergame condition as children receive the opportunity to play with other children online. The effect will not wane over time from the initial measurement period across three months. Our secondary outcomes of parents, physical fitness, total volume of physical activity and perceptions of the bikes will also be examined in the trial. Finally, we will also explore whether season (winter/summer), and gender (males/females) affect the use of the bikes.
- Study Design and Methods Design: Two-arm parallel design single blinded randomized controlled trial. Participants will be randomised to one of two groups 1) exergame-augmented condition; or 2) exergame standard condition for three months duration. Recruitment: Based on our prior studies, participants will be recruited via advertisements placed through home flyers at elementary/middle schools, cub scouts/brownies, recreation centres, health care centres, children's recreation classes, shopping malls and online interest sites.
Inclusion criteria (see below)
Randomisation and blinding: Families will be randomized at a 1:1 ratio to either intervention or control group, stratified by sex using a central computerised system. Participants will be aware of their group allocation, but all assessors will be blinded to treatment allocation. Justification of sample size: Based on our previous research with exergames, 80 families (40 per group) will be recruited to detect a medium effect size (f2 = .25; (38)) in adherence to physical activity (primary outcome) with a type one error of .05, an average correlation of .75 across time for our DV of interest, and a power of .80. Our sample size also considers the main 2 (group) x 2 (parent/child) x 4 (time) repeated measures design using G-Power and a potential 15% attrition rate.
Procedures and Protocol: After interested participants contact the researcher and are determined to be eligible to participate in the study, families will be visited on site for fitness testing and parents will be asked to complete a brief demographics, physical activity, and quality of life questionnaire while children are asked to complete a brief physical activity and quality of life questionnaire. We will employ a certified exercise physiologist to ensure consistency of the testing. The measurement team will be blind to the treatment conditions of the participants. The family will then be randomized into one of the two conditions. In the standard group, participants will play the games against computer-controlled opponents. In the augmented exergames intervention group, participants will play together, and will be able to talk with each other via a voice over IP link. A Facebook page will be developed allowing the publication of game news, and allowing players to communicate about the game, such as arranging play sessions. For security, only children or parents enrolled in the trail will be permitted to play the game online. The game will be available for play during scheduled times, with separate times for children and for adults.
After the initial six week intervention period, families will be given follow-up questionnaires to complete via an online survey tool. In addition to the brief questionnaires at three months, however, all family members will be asked to participate in a brief end-of-trial qualitative interview to evaluate the impact of the intervention. Although quantitative measurement of outcomes will provide insight into the potency of our exergames intervention, a process evaluation (whereby participants are interviewed) is also essential to examine the content fidelity ("what is done") and process fidelity ("how it is done") of program implementation.
Measures: (See below)
Analysis: Missing data will be evaluated for pattern of missingness for each psychosocial variable and behaviour at all time points using the dummy coding procedures. Depending on the outcome of these tests (e.g., missing at random, missing completely at random, etc.) we will initiate the appropriate missing data handling strategy. ITT analyses will also be performed in addition to sensitivity analysis procedures. A 2 (condition) x 3 (time) repeated measures factorial ANOVA on the primary outcome of child adherence to the bikes. A child from each household in the eligibility range will serve for this analysis (chosen through randomization procedures). Post hoc examinations using Tukey follow-up procedures will be utilized if necessary. Cluster analysis/HLM will be used for parent/child collinearity if needed. The qualitative analyses will incorporate the accuracy, thematic analysis, and coding.
Timeline: We expect the recruitment process to be ongoing across the first two years of the study and continuing for an additional 12 months for data analysis and write-up. The study should be achievable from start to finish in three years (i.e., two-funded years).
- Conditions
- Physical Activity
- Being tested
- Multi-player condition
- Keywords
- physical activity, exergames
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-player conditionBehavioural
Children in the multi-player condition will be able to play with and compete against other children in real time.
| Study group | Role | What they receive |
|---|---|---|
| Multi-player condition | Experimental | The multi-player condition examines the aspect of online gaming and social interaction with adherence to the exergame. Receives: Behavioral: Multi-player condition |
| Single-player condition | No intervention | This arm will look at whether those who play an exergame by themselves or with a computer generated player have the same adherence and use when compared to a multi-player condition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical activity
Physical activity will be measured via the Physical Activity Questionnaire for Children (PAQ-C) and objective data (use of gamebike) from the exergame. The PAQ-C assesses habitual moderate to vigorous physical activity in children and adolescents.
Measured: Baseline, 2 weeks, 4 weeks and 6 weeks.
Secondary outcomes (10)
Change in motivation
Motivation for physical activity will be measured using the constructs of the Theory of Planned Behaviour. These items will measure affective attitude, instrumental attitude, injunctive norm, descriptive norm and perceived behavioural control.
Measured: Time 1 after first assignment of condition, 2 weeks, 4 weeks and 6 weeks
Change in health-related quality of life/psychosocial distress
Children's Quality of Life will be assessed using the 5-item Satisfaction with Life Scale Adapted for Children (SWLS-C).
Measured: Baseline, 2 weeks, 4 weeks and 6 weeks.
Change in health-related fitness
Body composition, aerobic fitness and musculoskeletal fitness will be measured.
Measured: Baseline and 6 weeks
Change in parent and family based leisure time physical activity
Parent and family based LTPA will be measured by the Godin Leisure Time Exercise Questionnaire and the number of times family based physical activity occurs per week will also be assessed.
Measured: Baseline and at follow-up (6 weeks)
Change in equipment and home environment
The home environment questionnaire will look at the availability of physical activity equipment in the home for the child.
Measured: Baseline
Change in sedentary behaviour
Sedentary behaviour of the child will be assessed through parental reported behaviour of their child throughout the week
Measured: Baseline and follow up (6 week)
Change in social support
A social support questionnaire will be administered to the child to look at whether parents and friends of the child encourage the child to play sports, to be active and to play the exergame.
Measured: Baseline and follow up (6-weeks)
Change in elicited beliefs
The elicited beliefs questionnaire will look at the experience of the child throughout the intervention.
Measured: 2 weeks, 4 weeks and 6 weeks
Change in program belonging and social connectedness
Examining the sense of connection between players during gameplay throughout the intervention.
Measured: 2 weeks, 4 weeks and 6 weeks.
Gamer-type
This will be a web-based questionnaire looking at the type of elements in the videogame that the child is attracted to.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study startSep 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (64)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Victoria
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Cancer Society (CCS)
- Responsible party
- Principal investigator, Ryan Rhodes, University of Victoria
- Investigators
- Ryan Rhodes, Doctoral, Principal investigator, University of VictoriaNicholas Graham, Doctoral, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02032667
- Sponsor's protocol ID
- CCS-701723
- Status last verified
- May 2015
- First submitted
- 29 Dec 2013
- Last updated
- 7 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Statistics Canada. Table 102-0561 - Leading causes of death, total population, by age group and sex, Canada, annual, CANSIM (database). Journal [serial on the Internet]. 2012 Date: Available from: http://www5.statcan.gc.ca/cansim/pick-choisir?lang=eng&p2=33&id=1020561.
Stein CJ, Colditz GA. Modifiable risk factors for cancer. Br J Cancer. 2004 Jan 26;90(2):299-303. doi: 10.1038/sj.bjc.6601509.
PubMed 14735167Harvard Report on Cancer Prevention. Volume 1: Causes of human cancer. Cancer Causes Control. 1996 Nov;7 Suppl 1:S3-59. doi: 10.1007/BF02352719. No abstract available.
PubMed 9091058Adami HO, Day NE, Trichopoulos D, Willett WC. Primary and secondary prevention in the reduction of cancer morbidity and mortality. Eur J Cancer. 2001 Oct;37 Suppl 8:S118-27. doi: 10.1016/s0959-8049(01)00262-3.
PubMed 11602378Monninkhof EM, Elias SG, Vlems FA, van der Tweel I, Schuit AJ, Voskuil DW, van Leeuwen FE; TFPAC. Physical activity and breast cancer: a systematic review. Epidemiology. 2007 Jan;18(1):137-57. doi: 10.1097/01.ede.0000251167.75581.98.
PubMed 17130685Tardon A, Lee WJ, Delgado-Rodriguez M, Dosemeci M, Albanes D, Hoover R, Blair A. Leisure-time physical activity and lung cancer: a meta-analysis. Cancer Causes Control. 2005 May;16(4):389-97. doi: 10.1007/s10552-004-5026-9.
PubMed 15953981Harriss DJ, Atkinson G, Batterham A, George K, Cable NT, Reilly T, Haboubi N, Renehan AG; Colorectal Cancer, Lifestyle, Exercise And Research Group. Lifestyle factors and colorectal cancer risk (2): a systematic review and meta-analysis of associations with leisure-time physical activity. Colorectal Dis. 2009 Sep;11(7):689-701. doi: 10.1111/j.1463-1318.2009.01767.x. Epub 2009 Jan 17.
PubMed 19207713Colley RC, Garriguet D, Janssen I, Craig CL, Clarke J, Tremblay MS. Physical activity of Canadian adults: accelerometer results from the 2007 to 2009 Canadian Health Measures Survey. Health Rep. 2011 Mar;22(1):7-14.
PubMed 21510585Colley RC, Garriguet D, Janssen I, Craig CL, Clarke J, Tremblay MS. Physical activity of Canadian children and youth: accelerometer results from the 2007 to 2009 Canadian Health Measures Survey. Health Rep. 2011 Mar;22(1):15-23.
PubMed 21510586Jedwab J. Actively Canadian: Who's the most active of us all? : Association for Canadian Studies; 2005.
Statistics Canada. Canadian Community Health Survey 1994-2003. Government of Canada; 2005 [updated 2005; cited 2005 April 13]; Available from: http://www.acs-aec.ca/Polls/Physical%20Activity%20and%20Obesity.pdf.
O'Connor TM, Jago R, Baranowski T. Engaging parents to increase youth physical activity a systematic review. Am J Prev Med. 2009 Aug;37(2):141-9. doi: 10.1016/j.amepre.2009.04.020.
PubMed 19589450Nasuti G, Rhodes RE. Affective judgment and physical activity in youth: review and meta-analyses. Ann Behav Med. 2013 Jun;45(3):357-76. doi: 10.1007/s12160-012-9462-6.
PubMed 23297073Rhodes RE, Fiala B, Conner M. A review and meta-analysis of affective judgments and physical activity in adult populations. Ann Behav Med. 2009 Dec;38(3):180-204. doi: 10.1007/s12160-009-9147-y.
PubMed 20082164Barnett A, Cerin E, Baranowski T. Active video games for youth: a systematic review. J Phys Act Health. 2011 Jul;8(5):724-37. doi: 10.1123/jpah.8.5.724.
PubMed 21734319
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Games and Physical Activity: Does Multi-player Online Play Improve Adherence?
- ClinicalTrials.gov ID
- NCT02032667
- Acronym / sponsor ID
- CCS-701723
- Conditions
- Physical Activity
- Keywords
- physical activity, exergames
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of VictoriaUniversity, hospital or other
- Collaborators
- Canadian Cancer Society (CCS)
- Study start
- Sep 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 10 Jan 2014 (estimated)
- 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.
This study will be investigating an innovative and exciting way to increase physical activity in children between the ages of 9 and 12 years old. Families will be provided with a state-of-the-art exercise bike and video game console to have in their homes. The video games will provide a variety of play including racing, puzzle solving, collaborative play, team play and competitive play. We will be comparing whether a 'multi-player' condition has a greater adherence compared to a 'single-player' condition.
Detailed description
- Aims of the study: In 2005, the number of deaths attributed to cancer surpassed those caused by major cardiovascular diseases as the number one cause of mortality in Canada, and to this date, continues to significantly impact the lives of Canadians. As a response to the societal and individual afflictions from disease, it is imperative that research initiatives become more focused in the area of primary prevention. Reports have shown that at least half of all new cancer cases and deaths worldwide can be prevented. The largest impact on cancer development are lifestyle variables such as physical activity. Reviews and meta-analysis show a strong inverse linear relationship between physical activity and many of the most prevalent forms of cancer including breast, lung, and colon cancer (i.e., the more an individual exercises the less likely they are to develop cancer). Unfortunately, over 80% of the Canadian populace fails to meet these recommendations. To compound the problem of low physical activity prevalence, the largest declines in activity may occur early in life. Obviously, regular life-long physical activity is the desired outcome for lowering the risk of cancer; thus, promotion efforts targeting critical transitions to physical inactivity early in life are paramount. Two such groups are parents and their children, making family-based physical activity initiatives arguably the most important target for disease prevention. Unfortunately, physical activity interventions focused on the family home are limited and have resulted in negligible changes in physical activity for both children and their parents. Improvements are required in terms of the innovations of interventions. An area often overlooked when trying to increase physical participation is affective expectations or judgments (expected pleasure and enjoyment). Affective judgments are a central construct - in some form - in many of our popular health behaviour models, yet few interventions have focused on the modification of affective expectations, despite its reliable and robust association with physical activity. One such group of activities with this potential is interactive exercise videogaming (exergames). Exergaming is a relatively unexplored topic but early results and commentary have been very controversial; the topic has generated as many reviews as it has experimental trials. Overall, the emerging evidence suggests that these games can significantly increase energy expenditure similar to moderate intensity physical activities and these can translate into health-related fitness improvements. The research conducted from our group on this topic also shows this finding. Our studies employ exergames within the context of traditional exercise bikes (i.e., exercise bikes that interact with video games) because they demonstrate physical activity in the moderate to vigorous intensity range that results in marked fitness changes. Despite these positive effects, limited research is available to understand adherence to exergames. Further, of the available literature on exergames and exercise adherence, reviews find that the exergame conditions typically report higher adherence than various control conditions but long-term change is negligible or advantages diminish across time. Our research on the topic mirrors these overall conclusions. For example, in our family-based home pilot study of Game-bike, we showed significantly higher enjoyment and use for children in the exergame condition compared to a control bike across six weeks, yet the prominent differences were within the first three weeks and these were sharply declining in the later weeks. Thus, exergaming research that attempts to foster maintenance is needed to demonstrate that the initial high participation rate can be sustained within the context of the family home. This was the key recommendation from recent systematic reviews of exergames and it forms the rationale for the innovation in this proposal. Videogames, similar to these initial exergame results, show decline in playing frequency as games become familiar and the novelty wears. One of the most successful forms of videogaming has been the advent of synchronous multi-player online gaming. Games such as Blizzard's World of Warcraft are played online by millions of people. Specifically, videogames can been played with others online. Gamers may form online social clubs (teams, leagues or "guilds") allowing them to play regularly with the same group of people. The social attachments formed by players can be as strong as those held in the "physical" world, contributing to an extremely long maintenance playtime in comparison to ordinary gaming. To our knowledge, exergames with these properties have not been examined with families in the home. Nevertheless, there is an extensive body of research on the effects of social contexts in supporting physical activity adherence behaviour that suggest that people are more likely to sustain their involvement in a physical activity setting if they participate in social, or group-based, settings rather than on their own. In the context of this trial, if Canadian youth are provided with the opportunity to be part of a virtual group (through online synchronous game play), this will likely support their sense of social connectedness in relation to other youth in that condition, a greater degree of enjoyment of the intervention (affective judgements), and thereafter sustain their adherence behaviours. Thus, the primary research question: Does an interactive exergame bike augmented by synchronous online social play capability in comparison to 2) an exergame bike condition both within a family home environment result in greater use among children? Hypothesis: Adherence will be higher for the augmented exergame condition in comparison to the standard exergame condition as children receive the opportunity to play with other children online. The effect will not wane over time from the initial measurement period across three months. Our secondary outcomes of parents, physical fitness, total volume of physical activity and perceptions of the bikes will also be examined in the trial. Finally, we will also explore whether season (winter/summer), and gender (males/females) affect the use of the bikes.
- Study Design and Methods Design: Two-arm parallel design single blinded randomized controlled trial. Participants will be randomised to one of two groups 1) exergame-augmented condition; or 2) exergame standard condition for three months duration. Recruitment: Based on our prior studies, participants will be recruited via advertisements placed through home flyers at elementary/middle schools, cub scouts/brownies, recreation centres, health care centres, children's recreation classes, shopping malls and online interest sites.
Inclusion criteria (see below)
Randomisation and blinding: Families will be randomized at a 1:1 ratio to either intervention or control group, stratified by sex using a central computerised system. Participants will be aware of their group allocation, but all assessors will be blinded to treatment allocation. Justification of sample size: Based on our previous research with exergames, 80 families (40 per group) will be recruited to detect a medium effect size (f2 = .25; (38)) in adherence to physical activity (primary outcome) with a type one error of .05, an average correlation of .75 across time for our DV of interest, and a power of .80. Our sample size also considers the main 2 (group) x 2 (parent/child) x 4 (time) repeated measures design using G-Power and a potential 15% attrition rate.
Procedures and Protocol: After interested participants contact the researcher and are determined to be eligible to participate in the study, families will be visited on site for fitness testing and parents will be asked to complete a brief demographics, physical activity, and quality of life questionnaire while children are asked to complete a brief physical activity and quality of life questionnaire. We will employ a certified exercise physiologist to ensure consistency of the testing. The measurement team will be blind to the treatment conditions of the participants. The family will then be randomized into one of the two conditions. In the standard group, participants will play the games against computer-controlled opponents. In the augmented exergames intervention group, participants will play together, and will be able to talk with each other via a voice over IP link. A Facebook page will be developed allowing the publication of game news, and allowing players to communicate about the game, such as arranging play sessions. For security, only children or parents enrolled in the trail will be permitted to play the game online. The game will be available for play during scheduled times, with separate times for children and for adults.
After the initial six week intervention period, families will be given follow-up questionnaires to complete via an online survey tool. In addition to the brief questionnaires at three months, however, all family members will be asked to participate in a brief end-of-trial qualitative interview to evaluate the impact of the intervention. Although quantitative measurement of outcomes will provide insight into the potency of our exergames intervention, a process evaluation (whereby participants are interviewed) is also essential to examine the content fidelity ("what is done") and process fidelity ("how it is done") of program implementation.
Measures: (See below)
Analysis: Missing data will be evaluated for pattern of missingness for each psychosocial variable and behaviour at all time points using the dummy coding procedures. Depending on the outcome of these tests (e.g., missing at random, missing completely at random, etc.) we will initiate the appropriate missing data handling strategy. ITT analyses will also be performed in addition to sensitivity analysis procedures. A 2 (condition) x 3 (time) repeated measures factorial ANOVA on the primary outcome of child adherence to the bikes. A child from each household in the eligibility range will serve for this analysis (chosen through randomization procedures). Post hoc examinations using Tukey follow-up procedures will be utilized if necessary. Cluster analysis/HLM will be used for parent/child collinearity if needed. The qualitative analyses will incorporate the accuracy, thematic analysis, and coding.
Timeline: We expect the recruitment process to be ongoing across the first two years of the study and continuing for an additional 12 months for data analysis and write-up. The study should be achievable from start to finish in three years (i.e., two-funded years).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi-player condition | Experimental | Behavioral: Multi-player conditionThe multi-player condition examines the aspect of online gaming and social interaction with adherence to the exergame. |
| Single-player condition | No intervention | –This arm will look at whether those who play an exergame by themselves or with a computer generated player have the same adherence and use when compared to a multi-player condition. |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Participants will be children between the ages of 9 and 12 years old from the greater Victoria, B.C. area and Kingston, Ontario region. Children will be included if they participate in physical activity below Canadian recommended guidelines (for children under 60 minutes of activity daily).
- Participants must also pass the physical activity readiness protocol or seek physician clearance before participation.
- The families must also agree to having the exergaming station in an accessible location in their homes for the duration of the trial
- Will need high speed internet
Key exclusion criteria (3 listed)
- Children outside of the ages of 9 - 12 years
- Children who are active greater than recommended guidelines (more than 60 minutes of daily activity)
- Children with special needs (i.e. autism spectrum disorder, ADHD/ADD)
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 |
|---|---|---|
| Multi-player conditionChildren in the multi-player condition will be able to play with and compete against other children in real time. | Behavioural | Multi-player condition |
Primary outcome
Change in physical activity
Time frame: Baseline, 2 weeks, 4 weeks and 6 weeks.
Physical activity will be measured via the Physical Activity Questionnaire for Children (PAQ-C) and objective data (use of gamebike) from the exergame. The PAQ-C assesses habitual moderate to vigorous physical activity in children and adolescents.
10 secondary outcomes
Change in motivation
Time frame: Time 1 after first assignment of condition, 2 weeks, 4 weeks and 6 weeks
Change in health-related quality of life/psychosocial distress
Time frame: Baseline, 2 weeks, 4 weeks and 6 weeks.
Change in health-related fitness
Time frame: Baseline and 6 weeks
Change in parent and family based leisure time physical activity
Time frame: Baseline and at follow-up (6 weeks)
Change in equipment and home environment
Time frame: Baseline
Change in sedentary behaviour
Time frame: Baseline and follow up (6 week)
Change in social support
Time frame: Baseline and follow up (6-weeks)
Change in elicited beliefs
Time frame: 2 weeks, 4 weeks and 6 weeks
Change in program belonging and social connectedness
Time frame: 2 weeks, 4 weeks and 6 weeks.
Gamer-type
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2015.
- BackgroundStatistics Canada. Table 102-0561 - Leading causes of death, total population, by age group and sex, Canada, annual, CANSIM (database). Journal [serial on the Internet]. 2012 Date: Available from: http://www5.statcan.gc.ca/cansim/pick-choisir?lang=eng&p2=33&id=1020561.
- Background: PubMed 14735167Stein CJ, Colditz GA. Modifiable risk factors for cancer. Br J Cancer. 2004 Jan 26;90(2):299-303. doi: 10.1038/sj.bjc.6601509.
- Background: PubMed 9091058Harvard Report on Cancer Prevention. Volume 1: Causes of human cancer. Cancer Causes Control. 1996 Nov;7 Suppl 1:S3-59. doi: 10.1007/BF02352719. No abstract available.
- Background: PubMed 11602378Adami HO, Day NE, Trichopoulos D, Willett WC. Primary and secondary prevention in the reduction of cancer morbidity and mortality. Eur J Cancer. 2001 Oct;37 Suppl 8:S118-27. doi: 10.1016/s0959-8049(01)00262-3.
- Background: PubMed 17130685Monninkhof EM, Elias SG, Vlems FA, van der Tweel I, Schuit AJ, Voskuil DW, van Leeuwen FE; TFPAC. Physical activity and breast cancer: a systematic review. Epidemiology. 2007 Jan;18(1):137-57. doi: 10.1097/01.ede.0000251167.75581.98.
- Background: PubMed 15953981Tardon A, Lee WJ, Delgado-Rodriguez M, Dosemeci M, Albanes D, Hoover R, Blair A. Leisure-time physical activity and lung cancer: a meta-analysis. Cancer Causes Control. 2005 May;16(4):389-97. doi: 10.1007/s10552-004-5026-9.
- Background: PubMed 19207713Harriss DJ, Atkinson G, Batterham A, George K, Cable NT, Reilly T, Haboubi N, Renehan AG; Colorectal Cancer, Lifestyle, Exercise And Research Group. Lifestyle factors and colorectal cancer risk (2): a systematic review and meta-analysis of associations with leisure-time physical activity. Colorectal Dis. 2009 Sep;11(7):689-701. doi: 10.1111/j.1463-1318.2009.01767.x. Epub 2009 Jan 17.
- Background: PubMed 21510585Colley RC, Garriguet D, Janssen I, Craig CL, Clarke J, Tremblay MS. Physical activity of Canadian adults: accelerometer results from the 2007 to 2009 Canadian Health Measures Survey. Health Rep. 2011 Mar;22(1):7-14.
- Background: PubMed 21510586Colley RC, Garriguet D, Janssen I, Craig CL, Clarke J, Tremblay MS. Physical activity of Canadian children and youth: accelerometer results from the 2007 to 2009 Canadian Health Measures Survey. Health Rep. 2011 Mar;22(1):15-23.
- BackgroundJedwab J. Actively Canadian: Who's the most active of us all? : Association for Canadian Studies; 2005.
- BackgroundStatistics Canada. Canadian Community Health Survey 1994-2003. Government of Canada; 2005 [updated 2005; cited 2005 April 13]; Available from: http://www.acs-aec.ca/Polls/Physical%20Activity%20and%20Obesity.pdf.
- Background: PubMed 19589450O'Connor TM, Jago R, Baranowski T. Engaging parents to increase youth physical activity a systematic review. Am J Prev Med. 2009 Aug;37(2):141-9. doi: 10.1016/j.amepre.2009.04.020.
Related trials for Physical Activity
Enrolling by invitation
Physical Activity Interventions for Sleep Improvement and Sedative-Hypnotic Reduction in Middle-Aged and Older Adults: Investigating the Role of Sarcopenia
Insomnia Chronic, Hypnotics and Sedatives
Not yet recruiting
Effects of the 11 for Health Program on Physical Fitness and Health-Related Outcomes in Schoolchildren
Physical Fitness, Health
Active, not recruiting
A Mobile App to Improve 24-Hour Movement Guideline Adherence in Preschoolers
Healthy, 24-Hour Movement Guidelines
Recruiting
On Track for Wellness (OTW) Stepped Wedge Cluster Randomized Trial
Sleep, Physical Activity
Recruiting
The Sleep2BWell Trial
Blood Pressure, Sleep Health
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.
Ryan Rhodes, Doctoral principal investigator
University of Victoria
Nicholas Graham, Doctoral principal investigator
Queen's University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-player condition in people with Physical Activity, run by University of Victoria at 2 sites 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 3 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: finished, as of the sponsor's last update on 7 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physical activity (time frame: Baseline, 2 weeks, 4 weeks and 6 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02032667, which also lists 64 linked publications.
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 7 May 2015; AzTrials last refreshed its copy on 30 Oct 2026.