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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01171261
Other study ID # RWJ 64439
Secondary ID
Status Completed
Phase N/A
First received July 23, 2010
Last updated June 8, 2012
Start date May 2008
Est. completion date September 2010

Study information

Verified date June 2012
Source University of California, San Diego
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date September 2010
Est. primary completion date September 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 11 Years to 15 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Own another exergame in their home (such as a Wii or Dance Dance Revolution game)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Health Games Field Trial
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.

Locations

Country Name City State
United States UCSD, Atkinson Hall, 3rd Floor La Jolla California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 4 weeks No
Secondary 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. 4 weeks No
Secondary 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. 4 weeks No
Secondary 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. 4 weeks No
Secondary Motivation to Play Exergames A Motivation for Exergame Play Inventory was developed to assess motivation for exergame play. 4 weeks No
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