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The Fitness, Game Bike Adherence, Motivation and Exercise Study (FitGAME)

This study is currently recruiting participants.
Verified June 2011 by University of Victoria
Sponsor:
Collaborators:
Canadian Cancer Society
University of British Columbia
Dalhousie University
University of Auckland, New Zealand
Information provided by:
University of Victoria
ClinicalTrials.gov Identifier:
NCT01373762
First received: June 1, 2011
Last updated: June 15, 2011
Last verified: June 2011
History of Changes
  Purpose

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 six month period compared to the families in the stationary bike condition.


Condition Intervention
Physical Activity
 Behavioral: Exercise Videogame Bikes

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Interactive Videogame Bikes and Their Effect on Exercise Adherence and Health Related Fitness Among Families

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Victoria:

Primary Outcome Measures:
  • Children's self-reported adherence [ Time Frame: Usage log will be filled in for 6 month duration ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • parent's self-reported adherence [ Time Frame: Usage log will be filled in for 6 month duration ] [ Designated as safety issue: No ]
    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

  • Change from baseline in motivation at 6 weeks [ Time Frame: baseline & 6 weeks ] [ Designated as safety issue: No ]
    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).

  • Change in baseline in self-reported physical activity at 6 weeks [ Time Frame: baseline & 6 weeks ] [ Designated as safety issue: No ]
    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).

  • Change from baseline in health-related quality of life / psychosocial distress at 6 months [ Time Frame: baseline & 6 months ] [ Designated as safety issue: No ]
    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 6 months (i.e., post-intervention) will be examined.

  • Change from baseline in depression and anxiety at 6 months [ Time Frame: baseline & 6 months ] [ Designated as safety issue: No ]
    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 6 months (post-intervention) will be examined.

  • Change from baseline in physical self-perception at 6 months [ Time Frame: baseline & 6 months ] [ Designated as safety issue: No ]
    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 6 months (post-intrevention) will be examined.

  • Change from baseline in physical home environment at 6 months [ Time Frame: baseline & 6 months ] [ Designated as safety issue: No ]
    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 6 months (post-intervention).

  • Change from baseline in body composition at 6 months. [ Time Frame: baseline & 6 months ] [ Designated as safety issue: No ]
    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 6 months (post-intervention)

  • Change from baseline in cardiovascular fitness at 6 months [ Time Frame: baseline & 6 months ] [ Designated as safety issue: No ]
    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 6 months (i.e., post-intervention) will be examined.

  • Change from baseline in motivation at 3 months [ Time Frame: baseline & 3 months ] [ Designated as safety issue: No ]
    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).

  • Change from baseline in motivation at 6 months [ Time Frame: baseline & 6 months ] [ Designated as safety issue: No ]
    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 (6 months minus baseline).

  • Change from baseline in self-reported physical activity at 3 months [ Time Frame: Baseline & 3 months ] [ Designated as safety issue: No ]
    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).

  • Change from baseline in self-reported physical activity at 6 months [ Time Frame: baseline & 6 months ] [ Designated as safety issue: No ]
    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 (6 months minus baseline)


Estimated Enrollment: 160
Study Start Date: January 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise Videogame Bike
Families in this group will receive an interactive exercise videogame bike (ie. the Active Cycle) to keep in their home for six months.
 Behavioral: Exercise Videogame Bikes
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.
Other Name: Active Cycle (recumbent style), Hogan Health Industries, Inc
Stationary Bike
Families will receive a stationary bike to keep in their home for six 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
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.
Other Name: Active Cycle (recumbent style), Hogan Health Industries, Inc

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01373762

Contacts
Contact: Kristina Kowalski 1-250-472-5022 bml@uvic.ca

Locations
Canada, British Columbia
Behavioural Medicine Laboratory Recruiting
Victoria, British Columbia, Canada, V8W 3N4
Contact: Kristina Kowalski     1-250-472-5022     bml@uvic.ca    
Sub-Investigator: Kristina Kowalski            
Canada, Nova Scotia
Cardiovascular Research Unit Recruiting
Halifax, Nova Scotia, Canada, B3H 1V7
Contact: Chris Blanchard, PhD     1-902-473-3789     chris.blanchard@dal.ca    
Sponsors and Collaborators
University of Victoria
Canadian Cancer Society
University of British Columbia
Dalhousie University
University of Auckland, New Zealand
Investigators
Principal Investigator: Dr. Ryan R Rhodes, PhD University of Victoria
Study Chair: Dr. Chris Blanchard, PhD Dalhousie University
Study Chair: Dr. Ralph Maddison, PhD University of Auckland, New Zealand
Study Chair: Dr. Darren Warburton, PhD University of British Columbia
Study Chair: Dr. Shannon Bredin, PhD University of British Columbia
Study Chair: Dr. Mark Beauchamp, PhD University of British Columbia
  More Information

Publications:
Fishbein M, Triandis HC, Kanfer FH, Becker M, Middlestadt SE, Eichler A. Factors influencing behavior and behavior change. In: Baum A, Revenson TA, eds. Handbook of health psychology. Mahwah, New Jersey: Lawrence Erlbaum Associates; 2001:3-17.
Davison KK, Birch LL. Childhood overweight. Obesity Reviews 2:159-171, 2001.
Rhodes RE, Blanchard CM, Matheson DH. A multi-component model of the theory of planned behavior. British Journal of Health Psychology 11:119-137, 2006.
Deci EL, Ryan RM. The "what" and "why" of goal pursuits: Human needs and the self-determination of behaviour. Psychological Inquiry. 2000;11:227-268.
Hagger M, Chatzisarantis NLD, Biddle SJH. A meta-analytic review of the theories of reasoned action and planned behavior in physical activity: Predictive validity and the contribution of additional variables. Journal of Sport and Exercise Psychology. 2002;24:1-12.
Hausenblas HA, Carron AV, Mack DE. Application of the theories of reasoned action and planned behavior to exercise behavior: A meta-analysis. Journal of Sport and Exercise Psychology. 1997;19:36-51.
Rhodes RE, Courneya KS. Self-efficacy, controllability, and intention in the theory of planned behavior: Measurement redundancy or causal independence? Psychology and Health. 2003;18:79-91.
Rhodes RE, Courneya KS. Differentiating motivation and control in the theory of planned behavior. Psychology, Health and Medicine. 2004;9:205-215.
French DP, Sutton S, Hennings SJ, et al. The importance of affective beliefs and attitudes in the theory of planned behavior: Predicting intention to increase physical activity. Journal of Applied Social Psychology. 2005;35:1824-1848.
Lowe R, Eves F, Carroll D. The influence of affective and instrumental beliefs on exercise intentions and behavior: A longitudinal analysis. Journal of Applied Social Psychology. 2002;32:1241-1252.
Markland D, Tobin V. A modification to the behavioral regulation in exercise questionnaire to include an assessment of amotivation. Journal of Sport & Exercise Psychology. 2004;26:191-196.
Wilson PM, Rodgers WM. The relationship between perceived autonomy support, exercise regulations and behavioral intentions in women. Psychology of Sport & Exercise. 2004;5:229-242.
Diener E, Emmons RA, Larsen RJ, Griffin S. The satisfaction with life scale. Journal of Personality Assessment. 1985;49:71-75.

Responsible Party: Dr. Ryan Rhodes, University of Victoria
ClinicalTrials.gov Identifier: NCT01373762     History of Changes
Other Study ID Numbers: CCS-21041
Study First Received: June 1, 2011
Last Updated: June 15, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Victoria:
Adherence
Motivation
Health-related fitness
Exercise videogames
Physical Activity

ClinicalTrials.gov processed this record on May 22, 2013