Sedentary LifestyleNCT01171261
Testing Health Games for Adolescent Physical Activity
A study testing Health Games Field Trial in people with Sedentary Lifestyle, run by University of California, San Diego at 1 site in United States.
Trial summary
This is a RWJF funded study that will apply behavioral choice theory and learning theory principles to 'map' exergames to determine how behavior change principles influence sustained use of health games by adolescents. Read more about this study
- Who is it for?
- Ages 11 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- Health Games Field Trial
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Sep 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Are 11 - 15 years
- Provide assent and have a legal guardian that will participate and provide parental permission/consent
- Have a functioning telephone and at least one functioning television
Who cannot join
- Own another exergame in their home (such as a Wii or Dance Dance Revolution game)
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSD, Atkinson Hall, 3rd Floor
La Jolla, California, 92037-0811
About this study
Official title: Health Games Research: Advancing Effectiveness of Interactive Games for Health
This is a RWJF funded study that will apply behavioral choice theory and learning theory principles to 'map' exergames to determine how behavior change principles influence sustained use of health games by adolescents.
Read the detailed description
This research will assess and map four different exergame sports (bowling, boxing, tennis, and a mat/aerobics) games developed by Xavix for behavioral principles and evaluate how those behavior change principles impact game play sustainability. In the first phase of the study, we mapped and coded video games based on behavior contingencies of antecedents to the behavior, the behavior, and consequences to the behavior. Each of the games and subgames will be categorized as hi fidelity and lo fidelity.
Field Trial A home visit was scheduled for eligible and interested participants and an accelerometer was send to the participant's home to wear for one week prior to the home visit. Participants were randomized to one of four XaviX sports games: tennis, bowling, boxing, or J-mat. Two research assistants visited the participant's home to complete assent and consent forms, install the game on a television in the home, and give an overview on how to play the game. Participants were given a paper game log and instructed to record time spent playing the XaviX games. Participants were asked to play the exergame for as much or as little as they like for the next 4 weeks. The participant and parent completed a baseline survey during the visit. Participants continued to wear the accelerometer during the first week of exergame play and then returned the accelerometer by mail.
During the four weeks of exergame play, participants were contacted by telephone by study staff three times, approximately once a week, to complete short surveys about their game play and attitudes about the exergame, and to address any questions from participants. At week four, participants were mailed an accelerometer and instructed to wear it for seven days. After week four, a second home visit was conducted to collect the game cartridge and system, administer final surveys to the participant and a parent, and distribute the incentive. Participants received $50 for completing all study measurements.
Lab Trial In the lab phase, participants that completed the field trial and were randomized to the bowling, boxing, or J-Mat exergames were eligible to participate in the lab trial. During the lab trial, participants will play two subgames (a hi fidelity and a lo fidelity game) from the game that they were randomized to. Participants also completed a relative reinforcing value (RRV) task to assess reinforcing value of Xavix subgames ranked on theoretical fidelity and exertion. The RRV task is a method to measure the responsiveness of individuals to two or more choices. In the context of competing choice options, the RRV task assesses how much work an individual would be willing to do given increasing response effort to gain access to each option.
- Conditions
- Sedentary Lifestyle
- Being tested
- Health Games Field Trial
- Keywords
- Physical Activity, Sedentary Behavior, Video Games, Exergames
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Games Field TrialBehavioural
Also called Health Games, Exergames
There were 4 arms to the intervention in the field trial of this study. Participants were randomized to one of 4 arms or exergame that were manufactured by SSD/Xavix (Shiseido Co. of Japan). Each exergame consisted of a game cartridge, the XavixPort, and game controllers (e.g., tennis racquets, boxing gloves, bowling ball, or floor mat). The XavixPort interfaces the exergame with the participant's television and contains the infrared sensors that track the movement of the game controllers. Each exergame cartridge includes multiple game modes. The four arms/exergames were: XaviX Tennis, The Jackie Chan Studio Fitness (J-MAT), XaviX Bowling, and XaviX Boxing.
| Study group | Role | What they receive |
|---|---|---|
| Jackie Chan Studio Fitness | Experimental | The Jackie Chan Studio Fitness (J-MAT) cartridge includes four types of activities that use a four panel floor mat made of flexible material that functions as the wireless interface game controller. The celebrity actor and choreographer Jackie Chan is the avatar character in the game that demonstrates and guides users in four types of aerobic and anaerobic game modes. Receives: Behavioral: Health Games Field Trial |
| XaviX Tennis | Experimental | XaviX Tennis simulates tennis using a tennis racket controller and an infrared sensor to detect speed and timing of the player's swing of the racquet. The Tennis cartridge includes three playing modes. In Tournament Tour players select from eight different characters with different skills and play opponents in a bracketed tournament. In Exhibition mode players choose a computer opponent or play a tennis match with a friend. The Training Games mode includes a) Serving, b) Target Challenge, c) Serve \& Finish, and d) Rally Time. Receives: Behavioral: Health Games Field Trial |
| XaviX Bowling | Experimental | XaviX Bowling uses a wireless bowling ball game controller to simulate bowling. The cartridge includes three modes. In Regular Game up to four people can select from 8 preset bowlers with different characteristics. In Tournament Mode up to eight people can play. Challenge Games consists of three games called Against the Clock, Moving Pins, and Panel Crusher. Receives: Behavioral: Health Games Field Trial |
| XaviX Boxing | Experimental | XaviX Boxing uses boxing gloves as the game controller and allows players to box against five different computer opponents in Championship and Exhibition modes and to practice boxing skills in Exercise mode. Exercise mode includes Punch Fast, Panel Toucher, Punch the Red Ball, and Combination Training. Receives: Behavioral: Health Games Field Trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exergame Sustainability as a Measure of Game Play Over a 4-week Period
The amount of game play over a 4-week period was assessed by a self-report paper game play log on which to record the date, start and end time of game play. Participants also indicated the game mode (e.g. challenge games, tournament) and who, if anyone, they played the game with.
Measured: 4 weeks
Secondary outcomes (4)
Moderate and Vigorous Physical Activity
Physical activity was measured by accelerometer before the participant received the XaviX game, during the first week of having the XaviX game in the home, and during the final week that the XaviX game was in the home.
Measured: 4 weeks
Self-Report of Sedentary Behavior on non-school days
Self-reported sedentary time on a typical non-school day was assessed with a previously developed measure survey adapted from Robinson (1999). Participants were asked how much time they spent doing the following sedentary behaviors: (a) watching TV (including videos on VCR/DVD); (b) playing computer or video games (like Nintendo or Sega); (c) using the internet, emailing or other electronic media for leisure; (d) doing homework; (e) reading a book or magazine (not for school); (f) riding in a car, bus, etc.
Measured: 4 weeks
Attitudes about Exergames
Self-report of attitudes about exergames and the XaviX system were assessed through a 12-item scale on feelings about exergames, a price point question for the XaviX system and XaviX game cartridges, a survey on participants' experience with the XaviX system and game and why they would play XaviX in the future.
Measured: 4 weeks
Motivation to Play Exergames
A Motivation for Exergame Play Inventory was developed to assess motivation for exergame play.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2010 (estimated)
- Study startMay 2008
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Investigators
- Greg J Norman, PhD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01171261
- Sponsor's protocol ID
- RWJ 64439
- Status last verified
- Jun 2012
- First submitted
- 23 Jul 2010
- Last updated
- 11 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Games Research: Advancing Effectiveness of Interactive Games for Health
- ClinicalTrials.gov ID
- NCT01171261
- Acronym / sponsor ID
- RWJ 64439
- Conditions
- Sedentary Lifestyle
- Keywords
- Physical Activity, Sedentary Behavior, Video Games, Exergames
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 28 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a RWJF funded study that will apply behavioral choice theory and learning theory principles to 'map' exergames to determine how behavior change principles influence sustained use of health games by adolescents.
Detailed description
This research will assess and map four different exergame sports (bowling, boxing, tennis, and a mat/aerobics) games developed by Xavix for behavioral principles and evaluate how those behavior change principles impact game play sustainability. In the first phase of the study, we mapped and coded video games based on behavior contingencies of antecedents to the behavior, the behavior, and consequences to the behavior. Each of the games and subgames will be categorized as hi fidelity and lo fidelity.
Field Trial A home visit was scheduled for eligible and interested participants and an accelerometer was send to the participant's home to wear for one week prior to the home visit. Participants were randomized to one of four XaviX sports games: tennis, bowling, boxing, or J-mat. Two research assistants visited the participant's home to complete assent and consent forms, install the game on a television in the home, and give an overview on how to play the game. Participants were given a paper game log and instructed to record time spent playing the XaviX games. Participants were asked to play the exergame for as much or as little as they like for the next 4 weeks. The participant and parent completed a baseline survey during the visit. Participants continued to wear the accelerometer during the first week of exergame play and then returned the accelerometer by mail.
During the four weeks of exergame play, participants were contacted by telephone by study staff three times, approximately once a week, to complete short surveys about their game play and attitudes about the exergame, and to address any questions from participants. At week four, participants were mailed an accelerometer and instructed to wear it for seven days. After week four, a second home visit was conducted to collect the game cartridge and system, administer final surveys to the participant and a parent, and distribute the incentive. Participants received $50 for completing all study measurements.
Lab Trial In the lab phase, participants that completed the field trial and were randomized to the bowling, boxing, or J-Mat exergames were eligible to participate in the lab trial. During the lab trial, participants will play two subgames (a hi fidelity and a lo fidelity game) from the game that they were randomized to. Participants also completed a relative reinforcing value (RRV) task to assess reinforcing value of Xavix subgames ranked on theoretical fidelity and exertion. The RRV task is a method to measure the responsiveness of individuals to two or more choices. In the context of competing choice options, the RRV task assesses how much work an individual would be willing to do given increasing response effort to gain access to each option.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Jackie Chan Studio Fitness | Experimental | Behavioral: Health Games Field TrialThe Jackie Chan Studio Fitness (J-MAT) cartridge includes four types of activities that use a four panel floor mat made of flexible material that functions as the wireless interface game controller. The celebrity actor and choreographer Jackie Chan is the avatar character in the game that demonstrates and guides users in four types of aerobic and anaerobic game modes. |
| XaviX Tennis | Experimental | Behavioral: Health Games Field TrialXaviX Tennis simulates tennis using a tennis racket controller and an infrared sensor to detect speed and timing of the player's swing of the racquet. The Tennis cartridge includes three playing modes. In Tournament Tour players select from eight different characters with different skills and play opponents in a bracketed tournament. In Exhibition mode players choose a computer opponent or play a tennis match with a friend. The Training Games mode includes a) Serving, b) Target Challenge, c) Serve \& Finish, and d) Rally Time. |
| XaviX Bowling | Experimental | Behavioral: Health Games Field TrialXaviX Bowling uses a wireless bowling ball game controller to simulate bowling. The cartridge includes three modes. In Regular Game up to four people can select from 8 preset bowlers with different characteristics. In Tournament Mode up to eight people can play. Challenge Games consists of three games called Against the Clock, Moving Pins, and Panel Crusher. |
| XaviX Boxing | Experimental | Behavioral: Health Games Field TrialXaviX Boxing uses boxing gloves as the game controller and allows players to box against five different computer opponents in Championship and Exhibition modes and to practice boxing skills in Exercise mode. Exercise mode includes Punch Fast, Panel Toucher, Punch the Red Ball, and Combination Training. |
Who may qualify
- Ages
- 11 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Are 11 - 15 years
- Provide assent and have a legal guardian that will participate and provide parental permission/consent
- Have a functioning telephone and at least one functioning television
Key exclusion criteria (1 listed)
- Own another exergame in their home (such as a Wii or Dance Dance Revolution game)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Games Field TrialAlso: Health Games, ExergamesThere were 4 arms to the intervention in the field trial of this study. Participants were randomized to one of 4 arms or exergame that were manufactured by SSD/Xavix (Shiseido Co. of Japan). Each exergame consisted of a game cartridge, the XavixPort, and game controllers (e.g., tennis racquets, boxing gloves, bowling ball, or floor mat). The XavixPort interfaces the exergame with the participant's television and contains the infrared sensors that track the movement of the game controllers. Each exergame cartridge includes multiple game modes. The four arms/exergames were: XaviX Tennis, The Jackie Chan Studio Fitness (J-MAT), XaviX Bowling, and XaviX Boxing. | Behavioural | Jackie Chan Studio Fitness, XaviX Bowling, XaviX Boxing, XaviX Tennis |
Primary outcome
Exergame Sustainability as a Measure of Game Play Over a 4-week Period
Time frame: 4 weeks
The amount of game play over a 4-week period was assessed by a self-report paper game play log on which to record the date, start and end time of game play. Participants also indicated the game mode (e.g. challenge games, tournament) and who, if anyone, they played the game with.
4 secondary outcomes
Moderate and Vigorous Physical Activity
Time frame: 4 weeks
Self-Report of Sedentary Behavior on non-school days
Time frame: 4 weeks
Attitudes about Exergames
Time frame: 4 weeks
Motivation to Play Exergames
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Greg J Norman, PhD principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Games Field Trial in people with Sedentary Lifestyle, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exergame Sustainability as a Measure of Game Play Over a 4-week Period (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2012.