Clinical trial NCT02032667: Exercise Games and Physical Activity: Can a Home-based Exergame System Increase Physical Activity?
Official title: Exercise Games and Physical Activity: Does Multi-player Online Play Improve Adherence?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Keywords: physical activity
exergames
Lead sponsor: University of Victoria
Sponsor class: OTHER
Collaborators: name: Canadian Cancer Society (CCS)
First posted: 2014-01-10
Enrollment: 72
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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: 1. 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.
2. 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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Change in physical activity
timeFrame: Baseline, 2 weeks, 4 weeks and 6 weeks.
Secondary outcomes:
measure: Change in motivation
timeFrame: Time 1 after first assignment of condition, 2 weeks, 4 weeks and 6 weeks
measure: Change in health-related quality of life/psychosocial distress
timeFrame: Baseline, 2 weeks, 4 weeks and 6 weeks.
measure: Change in health-related fitness
timeFrame: Baseline and 6 weeks
measure: Change in parent and family based leisure time physical activity
timeFrame: Baseline and at follow-up (6 weeks)
measure: Change in equipment and home environment
timeFrame: Baseline
measure: Change in sedentary behaviour
timeFrame: Baseline and follow up (6 week)
measure: Change in social support
timeFrame: Baseline and follow up (6-weeks)
measure: Change in elicited beliefs
timeFrame: 2 weeks, 4 weeks and 6 weeks
measure: Change in program belonging and social connectedness
timeFrame: 2 weeks, 4 weeks and 6 weeks.
measure: Gamer-type
timeFrame: Baseline
Other outcomes:
measure: Sociodemographic measures
timeFrame: Baseline
Locations:
city: Victoria
country: Canada
facility: University of Victoria
state: British Columbia
city: Kingston
country: Canada
facility: Queens University
state: Ontario
Study officials:
affiliation: University of Victoria
name: Ryan Rhodes, Doctoral
role: PRINCIPAL_INVESTIGATOR
affiliation: Queen's University
name: Nicholas Graham, Doctoral
role: PRINCIPAL_INVESTIGATOR
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