Exercise Games and Physical Activity: Can a Home-based Exergame System Increase Physical Activity?
Condition: Physical Activity
Study type: Interventional

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).
    

Intervention name(s): Multi-player condition
Intervention type(s): Behavioral
Intervention description(s): Children in the multi-player condition will be able to play with and compete against other children in real time.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: physical activity; exergames