Physical Activity Clinical Trial
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.
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).
;
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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