The Fitness, Game Bike Adherence, Motivation and Exercise Study

Study Overview
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Brief Summary
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The purpose of this study is to determine whether an interactive exercise videogame bike is effective in improving physical activity adherence, motivations to do physical activity, and physical fitness among families. Families receive either an interactive videogame bike and gaming console, or a traditional stationary bike which is placed in front of the television, to keep in their home for six months. It is expected that families within the videogame bike condition will show greater exercise adherence. It is also expected that these families will have higher self-reported physical activity levels, greater motivation to do physical activity, and improved cardiovascular fitness at the end of the three month period compared to the families in the stationary bike condition.

Detailed Description
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Short title: Fit Game: Fitness & Game Bike Adherence, Motivation and Exercise Study Study period: 3 years Clinical phase: Phase III trial Background: Cancer is a significant economic burden in Canada, through direct costs to the health-care system (e.g., care and rehabilitation related to disease) and indirectly through lost economic output (e.g., missed work due to illness, premature death). At least half of all new cancer cases and deaths worldwide can be prevented, thus it is imperative that primary prevention become a focus of research. Recent research suggests a strong 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). Despite these findings, over half of the Canadian population fails to meet levels of physical activity recommended as a preventative measure. Additionally, it has been found that the largest declines in physical activity occur early in life; thus, promotion efforts targeting critical transitions to physical inactivity early in life are paramount. Findings from a Canadian Community Health Survey note that only 21% of Canadian youth are accumulating enough daily activity to meet international guidelines for optimal growth and development. As well, national cross-sectional and cohort studies on physical inactivity/overweight prevalence demonstrate that the most prominent deflection point is between ages 25 to 35, and this has been linked convincingly to the demands of parenthood. Thus, two important target groups for disease prevention are parents and their children through family-based physical activity initiatives. Unfortunately, interventions of this type are limited and have resulted in little changes in physical activity. Previous studies have focused heavily on education about the benefits/barriers of physical activity, followed by a self-monitoring and self-regulatory (e.g., goal-setting) component. One area that has been overlooked when trying to increase physical activity participation among youth, despite its reliable and robust association with physical activity, is the modification of affective expectations or judgements (expected pleasure or enjoyment). The introduction of new, enjoyable, and engaging exercise activities may present a novel approach to increase physical activity. One group of activities with this potential is interactive exercise video gaming including games such as the Game Bike system, Sony PlayStation EyeToy, and Nintendo Wii. These games allow players to interact physically (using leg, arm, or whole-body movement) in response to some on-screen virtual activity and provide a controlled opportunity for physical activity and exercise in a family environment. Emerging evidence suggests that these games can significantly increase energy expenditure similar to moderate to vigorous intensity physical activities that can translate into health-related fitness improvements. Our systematic review of existing active video game interventions highlight the potential of this approach to increase physical activity in children and young people. Additionally, our previous research with these games has also demonstrated the health-related fitness gains even when compared to standard cycling conditions. Despite these positive effects, there is very little information present to understand adherence to exercise videogames (EV). Our own research with university-aged males showed that an intervention group using an interactive Game bike attended 30% more sessions than a control group using traditional stationary exercise bikes. Even fewer studies on EV have evaluated the motivational properties of these games and the potential reasons for this improved adherence over control physical activity conditions. Only two studies have measured psychological constructs to examine effects of EV on motivation. Results of our previous work suggests that EV can effectively change affective judgments about physical activity and subsequent behaviour unlike most prior intervention efforts. Despite early positive findings, EV research has notable limitations. First, the populations employed in EV research have been limited to convenience samples of male undergraduate students. Research needs to expand to other samples in order to examine the reach of EV. Second, EV research has almost been exclusively conducted in a laboratory setting. While helpful for initial pilot/efficacy phase research, EV research needs to be conducted in ecologically valid locations. The family home seems an excellent test for whether EVs can still affect psychological, behavioural, and fitness outcomes when situated in a naturalistic location with other leisure-time stimuli. Finally, the length of EV trials has been limited to six-week longitudinal tests or single exposure examinations. Trials of longer duration would be very helpful to examine continuing interest in EV and subsequent adherence. It may be that EV provides a powerful novel experience in the short term but wanes similar to other exercise initiatives across time. Our proposed study will overcome these past limitations and advance the current knowledge of EV. Objectives: The primary objective of this study is to evaluate the effect of an interactive exercise video bike (i.e., Active Cycle) in comparison to a stationary bike (Active Cycle without the videogame controllers) in front of a TV on physical fitness, use of the bikes, and perceptions of the bikes. We will also explore whether season (winter/summer), age (parents/kids) and gender (males/females) affect the use of the various bikes. Study population: The targeted population will be inactive families within the Greater Victoria Area, British Columbia and the Greater Halifax Area, Nova Scotia, Canada. Number of subjects: A total of 160 families will be recruited (n=80 per group). 120 families will be recruited at the Greater Victoria site. The remainder will be recruited from Greater Halifax. Each family in the EV-interactive condition will receive a videogame bike (Hogan Health Industries, West Jordan, Utah) that will be linked into the family's Sony Playstation 2 or 3® (Sony Computer Entertainment America Inc, Foster City, California). If the family does not own a Sony Playstation 2 or 3® it will be provided to them for the duration of the intervention. Families will choose five videogames from a variety of Sony Playstation 2 or 3® videogames. At 3 months, families will be given the opportunity to select five new videogames, if they wish. Each family in the control group will receive a traditional stationary bike (i.e., an Active Cycle without the videogame controllers) which will be placed in front of their television. Statistical methods: Study power: A sample size of 160 families (80 per group) will be recruited to detect a small-medium effect size (f2 = .10) in adherence to physical activity (primary outcome) with a type one error of .05, an average correlation of .75 across time for our dependent variable (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 and a potential 15% attrition rate. The prediction-based research will be examined by group condition as well as via the collapsed sample for mediation analyses. Considering an average of 5 predictor independent variables (Theory of Planned Behavior (TPB) or Self-Determination Theory (SDT) models), and using a small-medium effect size (f2 = .10) we will have sufficient power (.80) to evaluate these predictors at an alpha of .05. Statistical analysis: Intention to treat analysis will be used to evaluate the main treatment effect. Missing data in the primary outcome measures will be imputed using a pre-specified approach. Research question 1 will be analyzed using a 2 (condition) x 4 (time) repeated measures factorial ANOVA on the primary outcome of child adherence to the bikes. A child (i.e., the target 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. Our secondary objectives (parent; parent/child; gender; season; fitness variables, etc.), will also be analyzed using a variant of this design with the addition of factors. Cluster analysis/Hierarchical Linear Modelling will be used for parent/child collinearity. Our pilot study (r = .21) and prior research suggests limited collinearity but it is appropriate to explore findings with these approaches given these are naturally clustered environments (i.e., family home). Prediction using our models (TPB, SDT) and questions of mediation will be achieved via multiple regression analyses following standard procedures for these types of tests. The qualitative analyses will incorporate the following processes: 1) Invite participants to review the transcripts of interviews, and summarize their perception of the data, for accuracy, and check for the trustworthiness of the data; 2) Conduct a thematic analysis using a reciprocal coding approach where researchers engage in open dialogue about themes and data interpretation. In doing so, each transcript is first reviewed independently, then through dialogue composite themes and related critical issues are developed; and 3) Manage the data using the NVivo software program. NVivo enables theory building, testing and elaboration. With NVivo, 'free nodes' can be created during the coding process, capturing participants' perspectives and the investigators' critical issues.

Official Title
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Interactive Videogame Bikes and Their Effect on Exercise Adherence and Health Related Fitness Among Families

Conditions
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Physical Activity

Intervention / Treatment
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* Behavioral: Exercise Videogame Bikes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Married or common law parents with children between the ages of 10 and 14 self-report low family physical activity At least 1 parent is not meeting Canada's Physical Activity Guidelines Target child is not meeting Canada's Physical Activity Guidelines Exclusion Criteria: Participant is unsafe to participate in physical activity as determined by answers to the Physical Activity Readiness Questionnaire (PAR-Q)

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Videogame Bike<br>Families in this group will receive an interactive exercise videogame bike (ie. the Active Cycle) to keep in their home for three months. | Behavioral: Exercise Videogame Bikes<br>* The intervention group will receive an exercise videogame bike that will be linked into their Sony Playstation 2® (Sony Computer Entertainment America Inc, Foster City, California). The Active Cycle® system reads the participant's cycling cadence which, in combination with a handlebar-mounted game controller, allows each participant to play a variety of Sony Playstation 2 and 3® videogames while exercising. The control-distraction group will receive a traditional stationary bike (i.e., same bike as the Active Cycle, but without the videogame controllers), which will be placed in front of their television. The recommended exercise training regime for both conditions will be activity of moderate intensity exercise (i.e., 60 to 75% of heart rate reserve), 3 days/week for 30 minutes/day.<br>* Other names: Active Cycle (recumbent style), Hogan Health Industries, Inc;|
| Other: Stationary Bike<br>Families will receive a stationary bike to keep in their home for three months. It is required that the family places the stationary bike (Active Cycle without video game controllers) in front of a television. | Behavioral: Exercise Videogame Bikes<br>* The intervention group will receive an exercise videogame bike that will be linked into their Sony Playstation 2® (Sony Computer Entertainment America Inc, Foster City, California). The Active Cycle® system reads the participant's cycling cadence which, in combination with a handlebar-mounted game controller, allows each participant to play a variety of Sony Playstation 2 and 3® videogames while exercising. The control-distraction group will receive a traditional stationary bike (i.e., same bike as the Active Cycle, but without the videogame controllers), which will be placed in front of their television. The recommended exercise training regime for both conditions will be activity of moderate intensity exercise (i.e., 60 to 75% of heart rate reserve), 3 days/week for 30 minutes/day.<br>* Other names: Active Cycle (recumbent style), Hogan Health Industries, Inc;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Children's self-reported adherence | The primary outcome measure will be children's self-report of adherence to physical activity. Adherence will be assessed with an equipment usage log, which will be filled out each time the child uses either the GameBike or stationary bike. Adherence will be measured using raw attendance scores. Proportion achieved based on the amount prescription will also be calculated. | Usage log will be filled in for 3 month duration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| parent's self-reported adherence | Adherence will be assessed with an equipment usage log, which will be filled out each time the child uses either the Active Cycle or stationary bike. Adherence will be measured using raw attendance scores. Proportion achieved based on the amount prescription will also be calculated | Usage log will be filled in for 3 month duration | 
| Change from baseline in motivation at 6 weeks | Motivations for physical activity will be using the constructs of the TPB and SDT including affective attitude, instrumental attitude, injunctive norm, descriptive norm, perceived control, behavioural, normative, control beliefs, intrinsic motivation, extrinsic motivation, and amotivation. The Behavioural Regulations in Exercise Questionnaire-2 (BREQ-2) will be completed by both parents and the target child. Change in motivation variables will be examined (6 weeks minus baseline). | baseline & 6 weeks | 
| Change in baseline in self-reported physical activity at 6 weeks | The target child will complete a modified version of the Physical Activity Questionnaire for Children (PAQ-C) to assess habitual moderate to vigorous physical activity. The Godin Leisure-Time Exercise Questionnaire (LSI) will be used to measure self-reported physical activity in parents. The LSI contains three questions, which assess the frequency of mild, moderate, and strenuous activity performed for at least 15 minutes during free time in a typical week. Change in self-reported physical activity will be examined (6 weeks minus baseline). | baseline & 6 weeks | 
| Change from baseline in health-related quality of life / psychosocial distress at 3 months | Quality of life will be assessed with parents using the Satisfaction with Life Scale and the 12 item Short Form Health Survey. The target child's quality of life will be assessed using the 5-item Satisfaction with Life Scale Adapted for Children (SWLS-C). Change in health-related quality of life/ psychosocial distress from baseline to 3 months (i.e., post-intervention) will be examined. | baseline & 3 months | 
| Change from baseline in depression and anxiety at 3 months | The presence and severity of symptoms of depression and anxiety in parents will be assessed using two brief measures: the Beck Depression Inventory, Second Edition (BDI-II) and the Beck Anxiety Inventory (BAI). Two scales from the Beck Youth Inventories will be used to measure the presence and severity of symptoms of depression and anxiety in youth. Change in depression and anxiety from baseline to 3 months (post-intervention) will be examined. | baseline & 3 months | 
| Change from baseline in physical self-perception at 3 months | Physical self-perception will be measured using the global physical self-worth, physical condition, and body attractiveness subscales from the Physical Self-Perception Profile (PSPP) and Children and Youth Physical Self-Perception Profile (CY-PSPP). Change in global physical self-worth, physical condition, and body attractiveness from baseline to 3 months (post-intrevention) will be examined. | baseline & 3 months | 
| Change from baseline in physical home environment at 3 months | The physical home environment will be assessed using three sections from the Active Where surveys (i.e., Section A. equipment checklist, Section P. Home Environment, & Section R. Sedentary Behavior). The Active Where surveys include items designed to to assess how the physical environment impacts the physical activity and eating behaviors of youth. Change in physical environment will be examined from baseline to 3 months (post-intervention). | baseline & 3 months | 
| Change from baseline in body composition at 3 months. | Body mass (kg), height (cm), body mass index, and waist circumference will be measured. Percentage body fat will be estimated via skinfolds (triceps, biceps, subscapular, supra iliac, medial calf) using standard anthropometric procedures. Change in body mass index (BMI), waist circumference, and percentage body fat will be examined from baseline to 3 months (post-intervention) | baseline & 3 months | 
| Change from baseline in cardiovascular fitness at 3 months | A submaximal cycle ergometer test on a calibrated Monark cycle ergometer will be used to assess cardiovascular fitness in both parents and target child. Heart rate, oxyhaemoglobin saturation (pulse oximetery), and blood pressure (sphygmomanometer and a stethoscope) will be monitored at rest and during exercise. Change in cardiovascular fitness from baseline to 3 months (i.e., post-intervention) will be examined. | baseline & 3 months | 
| Change from baseline in motivation at 3 months | Motivations for physical activity will be using the constructs of the TPB and SDT including affective attitude, instrumental attitude, injunctive norm, descriptive norm, perceived control, behavioural, normative, control beliefs, intrinsic motivation, extrinsic motivation, and amotivation. The BREQ-2 will be completed by both parents and the target child. Change in motivation variables will be examined (3 months minus baseline). | baseline & 3 months | 
| Change from baseline in self-reported physical activity at 3 months | The target child will complete a modified version of the PAQ-C to assess habitual moderate to vigorous physical activity. The LSI will be used to measure self-reported physical activity in parents. The LSI contains three questions, which assess the frequency of mild, moderate, and strenuous activity performed for at least 15 minutes during free time in a typical week. Change in self-reported physical activity will be examined (3 months minus baseline). | Baseline & 3 months | 
| Change from baseline in self-reported physical activity at 3 months | The target child will complete a modified version of the PAQ-C to assess habitual moderate to vigorous physical activity. The LSI will be used to measure self-reported physical activity in parents. The LSI contains three questions, which assess the frequency of mild, moderate, and strenuous activity performed for at least 15 minutes during free time in a typical week. Change in self-reported physical activity will be examined (3 months minus baseline) | baseline & 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adherence, Motivation, Health-related fitness, Exercise videogames, Physical Activity