Physical Inactivity in ChildrenExergamesNCT01024153
Active Video Games and Sustainable Physical Activity
A study testing Active video game play in people with Physical Inactivity in Children, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to test the effect of active video game play on physical activity of 9-13 year old children in their natural home environments. We observe how much physical activity children engage in after receiving two different active Wii video games and for how long they play. Read more about this study
- Who is it for?
- Ages 9 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity in Children
- What is being tested?
- Active video game play
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Dec 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 9 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children between the ages of 9-12 years old.
- Child and family are able to speak, understand, read and write English.
- No medical problems, including epileptic seizures, that would prevent child from playing inactive or active video games.
- No family history of epileptic seizures.
- Parents will allow child to play our video games.
- Household does not currently has a Wii video game console.
- Baseline visit activity monitor wear will be a compliance criterion for moving forward in the study. Although we ask for 7 days of data, if they return 5 complete days, then they meet the criteria. Without 5 complete days, they are dropped before randomization and thus before receiving the Wii. If we cannot get 5 or 7 days at baseline, it is unlikely that we will get 5 of 7 days at ensuing assessments (based on our 10+ years experience of collecting this type of data).
Who cannot join
- Children not between the ages of 9-12 years old.
- Child having epilepsy (since playing video games may lead to seizures among those with epilepsy).
- Family history of epileptic seizures.
- Household members not able to speak, understand, read and write English.
- Other medical problems that prevent child from playing inactive or active video games.
- Parents will not allow child to play our video games.
- Household currently has a Wii video game console.
- Child not wearing nor completing the initial baseline 7 day, minimum 800 minutes per day, activity monitor data collection.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Nutrition Research Center, Baylor College of Medicine
Houston, Texas, 77030
About this study
The purpose of this study is to test the effect of active video game play on physical activity of 9-13 year old children in their natural home environments. We observe how much physical activity children engage in after receiving two different active Wii video games and for how long they play. Active video games offer promise of minimizing children's physical inactivity.
Read the detailed description
The study aims to investigate (1) the temporal trajectory from point of accession of active and inactive video game play in the home environment, (2) the effect of active video game play on overall physical activity and BMI, (3) effects of motivational variables, perceived neighborhood safety, media parenting practices and the home media environment on game play, and (4) what video game characteristics encourage sustainability of play.
Eighty children and their primary caregivers will be recruited to participate in and randomly assigned to the approximately 12 week study. Participating families will be given a Wii* video game console, Wii accessories necessary to play the games and two active or inactive video games**: one at the beginning of the first 6-week period and one at the beginning of the second 6-week period. PA levels of participating children will be measured using accelerometry the week prior to the introduction of the video game (baseline) and on weeks 1, 6, 7, and 12. They will keep a log of video game play on weeks 1, 6, 7 and 12. Objective video game play time will be transcribed at the end of week 12 from calendar stored in the Wii console. Height, weight, waist circumference, triceps skinfold will be measured prior to beginning study (baseline), and weeks 6 and 12. Questionnaires designed to examine the motivation to play a video game (end of weeks 6 and 12) and brief (about 15 minutes) qualitative interview on the children's experiences with the games (end of weeks 6 and 12) will be administered. Parents will complete baseline, week 6 and week 12 questionnaires about their family and child.
*The Wii console has been chosen for this project as it is the platform for the majority of currently popular active video games and it also automatically stores information on name of game played and duration of game play for each play period in a day based calendar. This provides an objective measurement of game use within the family overall, which cannot be modified by the user and can only be deleted by resetting the system.
**To allow reasonably free choice of videos and close replication of the natural setting, the two video games given to a family will be chosen by the 9-12 year-old participant from a selection of either inactive or active video games (depending on group assignment). The Wii video games selected for this study are all rated E (Everyone) by the Entertainment Software Rating Board (E have content suitable for ages 6 and older) and were chosen based on current popularity and review of market rankings. The selected Wii video games include:
Inactive Wii video games: Madden NFL 10, Mario Kart Wii, Super Mario Galaxy and Super Mario Galaxy 2, Disney Sing It, Band Hero, Mario Party 8, Animal Crossing: City Folk, NBA 2K10, New Super Mario Brothers, Sim Animals Africa, Super Paper Mario and Endless Ocean 2: Beautiful Ocean.
Active Wii video games: Wii Sport Resort, Wii Sport, Wii Fit, Wii Play, EA Sports Active, Mario and Sonic at the Olympic Games, Dance, Dance Revolution, Active Life: Extreme Challenge, Academy of Champions, Summer Sports 2: Island Sports Party, and Super Monkey Ball Step and Roll.
- Conditions
- Physical Inactivity in Children
- Being tested
- Active video game play
- Keywords
- active video games, children, physical activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active video game playBehavioural
Children will get a Wii video game console and one game at week one and another at week 7. We will monitor their video game play and physical activity during this time.
| Study group | Role | What they receive |
|---|---|---|
| Active video game play | Experimental | Not described Receives: Behavioral: Active video game play |
What is being measured
The primary outcome is the main question the study is designed to answer.
increased physical activity
Measured: 4 months
Secondary outcomes (1)
BMI
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physical Inactivity in ChildrenStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Thomas Baranowski, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01024153
- Sponsor's protocol ID
- CA-140670
- Acronym
- Exergames
- Status last verified
- Feb 2012
- First submitted
- 1 Dec 2009
- Last updated
- 3 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
O'Connor TM, Chen TA, Baranowski J, Thompson D, Baranowski T. Physical activity and screen-media-related parenting practices have different associations with children's objectively measured physical activity. Child Obes. 2013 Oct;9(5):446-53. doi: 10.1089/chi.2012.0131. Epub 2013 Sep 12.
PubMed 24028564Baranowski T, Abdelsamad D, Baranowski J, O'Connor TM, Thompson D, Barnett A, Cerin E, Chen TA. Impact of an active video game on healthy children's physical activity. Pediatrics. 2012 Mar;129(3):e636-42. doi: 10.1542/peds.2011-2050. Epub 2012 Feb 27.
PubMed 22371457
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Video Games and Sustainable Physical Activity
- ClinicalTrials.gov ID
- NCT01024153
- Acronym / sponsor ID
- Exergames / CA-140670
- Conditions
- Physical Inactivity in Children
- Keywords
- active video games, children, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 2 Dec 2009 (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.
The purpose of this study is to test the effect of active video game play on physical activity of 9-13 year old children in their natural home environments. We observe how much physical activity children engage in after receiving two different active Wii video games and for how long they play. Active video games offer promise of minimizing children's physical inactivity.
Detailed description
The study aims to investigate (1) the temporal trajectory from point of accession of active and inactive video game play in the home environment, (2) the effect of active video game play on overall physical activity and BMI, (3) effects of motivational variables, perceived neighborhood safety, media parenting practices and the home media environment on game play, and (4) what video game characteristics encourage sustainability of play.
Eighty children and their primary caregivers will be recruited to participate in and randomly assigned to the approximately 12 week study. Participating families will be given a Wii* video game console, Wii accessories necessary to play the games and two active or inactive video games**: one at the beginning of the first 6-week period and one at the beginning of the second 6-week period. PA levels of participating children will be measured using accelerometry the week prior to the introduction of the video game (baseline) and on weeks 1, 6, 7, and 12. They will keep a log of video game play on weeks 1, 6, 7 and 12. Objective video game play time will be transcribed at the end of week 12 from calendar stored in the Wii console. Height, weight, waist circumference, triceps skinfold will be measured prior to beginning study (baseline), and weeks 6 and 12. Questionnaires designed to examine the motivation to play a video game (end of weeks 6 and 12) and brief (about 15 minutes) qualitative interview on the children's experiences with the games (end of weeks 6 and 12) will be administered. Parents will complete baseline, week 6 and week 12 questionnaires about their family and child.
*The Wii console has been chosen for this project as it is the platform for the majority of currently popular active video games and it also automatically stores information on name of game played and duration of game play for each play period in a day based calendar. This provides an objective measurement of game use within the family overall, which cannot be modified by the user and can only be deleted by resetting the system.
**To allow reasonably free choice of videos and close replication of the natural setting, the two video games given to a family will be chosen by the 9-12 year-old participant from a selection of either inactive or active video games (depending on group assignment). The Wii video games selected for this study are all rated E (Everyone) by the Entertainment Software Rating Board (E have content suitable for ages 6 and older) and were chosen based on current popularity and review of market rankings. The selected Wii video games include:
Inactive Wii video games: Madden NFL 10, Mario Kart Wii, Super Mario Galaxy and Super Mario Galaxy 2, Disney Sing It, Band Hero, Mario Party 8, Animal Crossing: City Folk, NBA 2K10, New Super Mario Brothers, Sim Animals Africa, Super Paper Mario and Endless Ocean 2: Beautiful Ocean.
Active Wii video games: Wii Sport Resort, Wii Sport, Wii Fit, Wii Play, EA Sports Active, Mario and Sonic at the Olympic Games, Dance, Dance Revolution, Active Life: Extreme Challenge, Academy of Champions, Summer Sports 2: Island Sports Party, and Super Monkey Ball Step and Roll.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active video game play | Experimental | Behavioral: Active video game play |
Who may qualify
- Ages
- 9 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children between the ages of 9-12 years old.
- Child and family are able to speak, understand, read and write English.
- No medical problems, including epileptic seizures, that would prevent child from playing inactive or active video games.
- No family history of epileptic seizures.
- Parents will allow child to play our video games.
Key exclusion criteria (8 listed)
- Children not between the ages of 9-12 years old.
- Child having epilepsy (since playing video games may lead to seizures among those with epilepsy).
- Family history of epileptic seizures.
- Household members not able to speak, understand, read and write English.
- Other medical problems that prevent child from playing inactive or active video games.
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 |
|---|---|---|
| Active video game playChildren will get a Wii video game console and one game at week one and another at week 7. We will monitor their video game play and physical activity during this time. | Behavioural | Active video game play |
Primary outcome
increased physical activity
Time frame: 4 months
1 secondary outcome
BMI
Time frame: 4 months
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 3 Feb 2012.
- Derived from this study: PubMed 24028564O'Connor TM, Chen TA, Baranowski J, Thompson D, Baranowski T. Physical activity and screen-media-related parenting practices have different associations with children's objectively measured physical activity. Child Obes. 2013 Oct;9(5):446-53. doi: 10.1089/chi.2012.0131. Epub 2013 Sep 12.
- Derived from this study: PubMed 22371457Baranowski T, Abdelsamad D, Baranowski J, O'Connor TM, Thompson D, Barnett A, Cerin E, Chen TA. Impact of an active video game on healthy children's physical activity. Pediatrics. 2012 Mar;129(3):e636-42. doi: 10.1542/peds.2011-2050. Epub 2012 Feb 27.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active video game play in people with Physical Inactivity in Children, run by Baylor College of Medicine 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 7 inclusion and 8 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 3 Feb 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?
increased physical activity (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01024153, which also lists 2 linked publications.
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 3 Feb 2012.