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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01430715
Other study ID # 8556
Secondary ID
Status Completed
Phase N/A
First received August 5, 2011
Last updated April 3, 2018
Start date July 2011
Est. completion date October 2011

Study information

Verified date April 2018
Source The University of Tennessee, Knoxville
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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:

1. 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.

2. 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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date October 2011
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender All
Age group 5 Years to 8 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Active vido games and outdoor play
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.

Locations

Country Name City State
United States The Early Learning Center Knoxville Tennessee

Sponsors (1)

Lead Sponsor Collaborator
The University of Tennessee, Knoxville

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. within the study's 4 month period
Secondary 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. within the study's 4 month time frame
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