Motor ActivityNCT01430715
Estimating Energy Expenditure in Active Video Gaming Compared to Unstructured, Outdoor Play in Children
A study testing Active vido games and outdoor play in people with Motor Activity, run by The University of Tennessee, Knoxville at 1 site in United States.
Trial summary
The increasing use of sedentary screen-based activities (SBAs) has been most recently blamed for children and adolescents' lack of engagement in physical activity (PA). Studies indicate a large portion of children participate high-levels of sedentary SBAs and the sedentary SBAs appear to compete for time to engage in… Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Motor Activity
- What is being tested?
- Active vido games and outdoor play
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Oct 2011
- 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 5 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All children between 5- to 8- years of age and enrolled in the ELC, with parental consent can participate. Children must be healthy, with an absence of any known cardiopulmonary, metabolic, or orthopedic disease condition or ailment that would limit their participation in the study. Also, children with any type of grass allergy and sensitivity to sunlight will not be included in the study. Additionally, children must be of healthy weight with a body mass index (BMI)-for-age percentile between, > 5th % to < 85th %. Eligible children must also agree to be observed during outdoor activity and while playing the video game.
Who cannot join
- Children who are not between 5- to 8- years of age and those who are not enrolled in the ELC, and do not obtain parental consent will not be allowed to participate. Children must be healthy, those with any known cardiopulmonary, metabolic, or orthopedic disease condition or aliment that would limit their physical activity, cannot participate in the study. Also, children with any type of grass allergy and sensitivity to sunlight will not be included in the study. Additionally, children must be of healthy weight with a body mass index (BMI)-for-age percentile between, > 5% to < 85%. Children above or below the healthy weight criteria (body mass index (BMI)-for-age percentile below the 5th percentile or above the 85th percentile), will be ineligible and not be able to participate in the study. Eligible children must also agree to be observed during outdoor activity and video-recorded while playing the video game, those children who do not agree to be observed cannot participate in the research study.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Early Learning Center
Knoxville, Tennessee, 37996-1912
About this study
Official title: Active Video Gaming Compared to Unstructured, Outdoor Play in Children: Measurements of Estimated Energy Expenditure and Measured Percent Time in Moderate-to-Vigorous Physical Activity
The increasing use of sedentary screen-based activities (SBAs) has been most recently blamed for children and adolescents' lack of engagement in physical activity (PA). Studies indicate a large portion of children participate high-levels of sedentary SBAs and the sedentary SBAs appear to compete for time to engage in PA. If sedentary behavior is a substitute for PA, to help increase PA, strategies need to be put into place that helps to decrease sedentary behaviors.
One modification to sedentary videogames that may increase PA in children is to alter sedentary videogames so that the videogames actually provide an option to engage in PA, rather than to be sedentary. These types of games then don't compete with PA, but actually are a source of PA. These types of videogames are called active video games (AVG) or "Exer-gaming." Previous research demonstrates that energy-expenditure (EE) in AVG play is comparable to moderate-intensity walking and produce greater EE than sedentary SBAs. However, previous studies have been limited to measuring EE in AVG play to walking either on a treadmill or in a structured setting. Studies have not investigated the EE of AVG play compared to the EE in free-living outdoor play. Thus, the purpose of the proposed study is to determine whether a greater EE is released during AVG play compared to free-living, outdoor play in children.
Read the detailed description
Fifteen children, aged 5- to 8- years, attending a nearby preschool, with a normal body mass index (BMI)-for-age percentile between, > 5th % to < 85th %.BMI, will participate in unstructured, outdoor play and one AVGs in a randomized order. Activity type, duration and intensity will be measured via accelerometery and direct observation. The EE will be calculated from Metabolic Equivalent (MET) values and the percent of time each activity meets MVPA intensity will be calculated. A MET is the energy cost of the activity expressed as kilocalories expended per kilogram of body weight per hour of activity (7). If EE and intensity in AVG play is similar to EE and intensity in outdoor play, then AVG play could be a great supplement to efforts aimed at increasing PA in children.
Specific Aims:
- To measure the EE acquired in 15 minutes during an AVG, an adventure game, as compared to unstructured outdoor play in children 5- to 8- years of age.
- To compare the percent of time each activity meets the definition of MVPA (MET value >3) in children aged 5- to 8-years of age.
- Conditions
- Motor Activity
- Being tested
- Active vido games and outdoor play
- Keywords
- active video game, video gaming, accelerometery, MVPA, outdoor play, children, unstructured, energy expenditure
- 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 vido games and outdoor playOther
Also called active video games, outdoor play, accelerometery
Fifteen children, aged 5- to 8- years, attending a nearby preschool, with a normal body mass index (BMI)-for-age percentile between, > 5th % to < 85th %.BMI, will participate in unstructured, outdoor play and one AVGs in a randomized order. Activity type, duration and intensity will be measured via accelerometery and direct observation. The energy expenditure (EE) will be calculated from Metabolic Equivalent (MET) values and the percent of time each activity meets MVPA intensity will be calculated. A MET is the energy cost of the activity expressed as kilocalories expended per kilogram of body weight per hour of activity. If EE and intensity in AVG play is similar to EE and intensity in outdoor play, then AVG play could be a great supplement to efforts aimed at increasing PA in children.
| Study group | Role | What they receive |
|---|---|---|
| Outside play | Experimental | Not described Receives: Other: Active vido games and outdoor play |
| Active video game | Experimental | Not described Receives: Other: Active vido games and outdoor play |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measured the EE acquired in 15 minutes during an AVG, an adventure game, as compared to unstructured outdoor play in children 5- to 8- years of age
Fifteen children, aged 5- to 8- years, with a normal body mass index (BMI)-for-age, will participate in unstructured, outdoor play and one AVGs in a randomized order. Activity type, duration and intensity will be measured via accelerometery and direct observation. The energy expenditure (EE) will be calculated from Metabolic Equivalent (MET) values and the percent of time each activity meets MVPA intensity will be calculated. If EE and intensity in AVG play is similar to EE and intensity in outdoor play, then AVG play could be a great supplement to efforts aimed at increasing PA in children.
Measured: within the study's 4 month period
Secondary outcomes (1)
Compared the percent of time each activity meets the definition of MVPA (MET value >3) in children aged 5- to 8-years of age
Fifteen children, aged 5- to 8- years, with a normal body mass index (BMI)-for-age, will participate in unstructured, outdoor play and one AVGs in a randomized order. Activity type, duration and intensity will be measured via accelerometery and direct observation. The energy expenditure (EE) will be calculated from Metabolic Equivalent (MET) values and the percent of time each activity meets MVPA intensity will be calculated. If EE and intensity in AVG play is similar to EE and intensity in outdoor play, then AVG play could be a great supplement to efforts aimed at increasing PA in children.
Measured: within the study's 4 month time frame
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2011 (estimated)
- Study startJul 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor ActivityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hollie Raynor, The University of Tennessee, Knoxville
- Investigators
- Hollie A Raynor, Ph.D, Study director, The University of Tennessee, KnoxvilleSusan B MacArthur, B.S., Principal investigator, The University of Tennessee, Knoxville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01430715
- Sponsor's protocol ID
- 8556
- Status last verified
- Apr 2018
- First submitted
- 5 Aug 2011
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Video Gaming Compared to Unstructured, Outdoor Play in Children: Measurements of Estimated Energy Expenditure and Measured Percent Time in Moderate-to-Vigorous Physical Activity
- ClinicalTrials.gov ID
- NCT01430715
- Acronym / sponsor ID
- 8556
- Conditions
- Motor Activity
- Keywords
- active video game, video gaming, accelerometery, MVPA, outdoor play, children, unstructured, energy expenditure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 8 Sep 2011 (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 increasing use of sedentary screen-based activities (SBAs) has been most recently blamed for children and adolescents' lack of engagement in physical activity (PA). Studies indicate a large portion of children participate high-levels of sedentary SBAs and the sedentary SBAs appear to compete for time to engage in PA. If sedentary behavior is a substitute for PA, to help increase PA, strategies need to be put into place that helps to decrease sedentary behaviors.
One modification to sedentary videogames that may increase PA in children is to alter sedentary videogames so that the videogames actually provide an option to engage in PA, rather than to be sedentary. These types of games then don't compete with PA, but actually are a source of PA. These types of videogames are called active video games (AVG) or "Exer-gaming." Previous research demonstrates that energy-expenditure (EE) in AVG play is comparable to moderate-intensity walking and produce greater EE than sedentary SBAs. However, previous studies have been limited to measuring EE in AVG play to walking either on a treadmill or in a structured setting. Studies have not investigated the EE of AVG play compared to the EE in free-living outdoor play. Thus, the purpose of the proposed study is to determine whether a greater EE is released during AVG play compared to free-living, outdoor play in children.
Detailed description
Fifteen children, aged 5- to 8- years, attending a nearby preschool, with a normal body mass index (BMI)-for-age percentile between, > 5th % to < 85th %.BMI, will participate in unstructured, outdoor play and one AVGs in a randomized order. Activity type, duration and intensity will be measured via accelerometery and direct observation. The EE will be calculated from Metabolic Equivalent (MET) values and the percent of time each activity meets MVPA intensity will be calculated. A MET is the energy cost of the activity expressed as kilocalories expended per kilogram of body weight per hour of activity (7). If EE and intensity in AVG play is similar to EE and intensity in outdoor play, then AVG play could be a great supplement to efforts aimed at increasing PA in children.
Specific Aims:
- To measure the EE acquired in 15 minutes during an AVG, an adventure game, as compared to unstructured outdoor play in children 5- to 8- years of age.
- To compare the percent of time each activity meets the definition of MVPA (MET value >3) in children aged 5- to 8-years of age.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Outside play | Experimental | Other: Active vido games and outdoor play |
| Active video game | Experimental | Other: Active vido games and outdoor play |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children between 5- to 8- years of age and enrolled in the ELC, with parental consent can participate. Children must be healthy, with an absence of any known cardiopulmonary, metabolic, or orthopedic disease condition or ailment that would limit their participation in the study. Also, children with any type of grass allergy and sensitivity to sunlight will not be included in the study. Additionally, children must be of healthy weight with a body mass index (BMI)-for-age percentile between, > 5th % to < 85th %. Eligible children must also agree to be observed during outdoor activity and while playing the video game.
Key exclusion criteria (1 listed)
- Children who are not between 5- to 8- years of age and those who are not enrolled in the ELC, and do not obtain parental consent will not be allowed to participate. Children must be healthy, those with any known cardiopulmonary, metabolic, or orthopedic disease condition or aliment that would limit their physical activity, cannot participate in the study. Also, children with any type of grass allergy and sensitivity to sunlight will not be included in the study. Additionally, children must be of healthy weight with a body mass index (BMI)-for-age percentile between, > 5% to < 85%. Children above or below the healthy weight criteria (body mass index (BMI)-for-age percentile below the 5th percentile or above the 85th percentile), will be ineligible and not be able to participate in the study. Eligible children must also agree to be observed during outdoor activity and video-recorded while playing the video game, those children who do not agree to be observed cannot participate in the research study.
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 vido games and outdoor playAlso: active video games, outdoor play, accelerometeryFifteen children, aged 5- to 8- years, attending a nearby preschool, with a normal body mass index (BMI)-for-age percentile between, > 5th % to < 85th %.BMI, will participate in unstructured, outdoor play and one AVGs in a randomized order. Activity type, duration and intensity will be measured via accelerometery and direct observation. The energy expenditure (EE) will be calculated from Metabolic Equivalent (MET) values and the percent of time each activity meets MVPA intensity will be calculated. A MET is the energy cost of the activity expressed as kilocalories expended per kilogram of body weight per hour of activity. If EE and intensity in AVG play is similar to EE and intensity in outdoor play, then AVG play could be a great supplement to efforts aimed at increasing PA in children. | Other | Active video game, Outside play |
Primary outcome
Measured the EE acquired in 15 minutes during an AVG, an adventure game, as compared to unstructured outdoor play in children 5- to 8- years of age
Time frame: within the study's 4 month period
Fifteen children, aged 5- to 8- years, with a normal body mass index (BMI)-for-age, will participate in unstructured, outdoor play and one AVGs in a randomized order. Activity type, duration and intensity will be measured via accelerometery and direct observation. The energy expenditure (EE) will be calculated from Metabolic Equivalent (MET) values and the percent of time each activity meets MVPA intensity will be calculated. If EE and intensity in AVG play is similar to EE and intensity in outdoor play, then AVG play could be a great supplement to efforts aimed at increasing PA in children.
1 secondary outcome
Compared the percent of time each activity meets the definition of MVPA (MET value >3) in children aged 5- to 8-years of age
Time frame: within the study's 4 month time frame
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 5 Apr 2018.
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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.
Hollie A Raynor, Ph.D study director
The University of Tennessee, Knoxville
Susan B MacArthur, B.S. principal investigator
The University of Tennessee, Knoxville
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 vido games and outdoor play in people with Motor Activity, run by The University of Tennessee, Knoxville 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 1 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 5 Apr 2018. 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?
Measured the EE acquired in 15 minutes during an AVG, an adventure game, as compared to unstructured outdoor play in children 5- to 8- years of age (time frame: within the study's 4 month period). 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 5 Apr 2018.