- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03720938
Effects of Active Video Games in Physically Inactive Children (AVGAME)
A Digital Movement in the World of Inactive Children: Outcomes of Playing Active Video Games in a Pilot Randomized Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Research related a causal association between inactivity, low esteem, and excess weight for children. For this reason, academic performance decreases and obesity associated diseases such as hypertension, diabetes, coronary heart diseases, depression, and cancer might ensue. Children usually do not prefer to perform outdoor PA due to several causes including low sense of self perception.
So far studies have shown an almost equivalent energy spent through AVGs to the physical activity of moderate intensity. Games have been previously demonstrated to prevent excess weight. There were no studies of AVG in children with varying weights, inactivity and technology preoccupation. Similarly, no qualitative research of AVG in children exploring enjoyment levels and attitude changes were encountered.
Thus, the investigators aim to find the quantitative effect of AVG on physical fitness parameters like weight, BMI and FR. Other aims are studying factors for motivation or continuance of the games as well as the feelings and perspectives of the participant children's parents for the games.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Being 8-13 years old
- Being preoccupied with technology
- Being physically inactive
Exclusion Criteria:
- Having circulatory, respiratory and musculoskeletal disease
- Having neuropsychiatric diseases
- History of syncope or seizures
- History of exercise induced anaphylaxis
- Morbid obesity
- Short stature
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Control Group
Physically inactive children who did not play AVGs.
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EXPERIMENTAL: Intervention Group
Physically inactive children who played alternately Nintendo Wii® active video games for 50-60 min, 3 days a week, 12 weeks, in laboratory environment.
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Nintendo Wii® AVGs from sports, balance, aerobics, resort and training categories.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight in Kilograms
Time Frame: Baseline, 12 weeks
|
Weight measured to the nearest 0.01 kg by Seca 767 scale.
The first before the games, the second after the games.
|
Baseline, 12 weeks
|
Weight z Score
Time Frame: Baseline, 12 weeks
|
Weight measured to the nearest 0.01 kg by Seca 767 scale.
Z scores were calculated using national data for Turkish children.
The first before the games, the second after the games.
Positive z-scores indicates the number of standard deviations of the child above the mean of the population of the same age, whereas negative z-scores indicates the number of standard deviations of the child below the mean of the population of the same age.
|
Baseline, 12 weeks
|
BMI Calculated as "Weight (kg) / Height (m^2)"
Time Frame: Baseline, 12 weeks
|
Body Mass Index calculation of both groups before the games and after the games.
|
Baseline, 12 weeks
|
BMI z Score
Time Frame: Baseline, 12 weeks
|
Weight and height were measured to the nearest 0.01 kg (Seca 767) and 0.1 cm (Seca 220).
BMI Z-scores were calculated using national data for Turkish children derived from values obtained from calculations with Quetelet index.
The first before the games, the second after the games.
Positive BMI z-scores indicates the number of standard deviations of the child above the mean of the population of the same age, whereas negative z-scores indicates the number of standard deviations of the child below the mean of the population of the same age.
|
Baseline, 12 weeks
|
Body Fat Percentage as Determined by Siri Formula From Skinfold Thicknesses
Time Frame: Baseline, 12 weeks
|
The biceps, triceps, suprailiac and subscapular regions skinfold thicknesses were measured by Holtain caliper at the beginning of and after the games.
Durnin-Womersley formula was used to calculate body densities.
Then fat ratio of whole body was derived from the Siri equation by integrating body densities obtained by Durnin-Womersley formula.
|
Baseline, 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Reaction Times of Dominant Hand by Newtest 1000 Timer
Time Frame: Baseline, 12 weeks
|
Determination of visual reaction times after games in intervention groups, and control groups.
First before the games, second after the games.
|
Baseline, 12 weeks
|
Visual Reaction Times of Non-dominant Hand by Newtest 1000 Timer
Time Frame: Baseline, 12 weeks
|
Baseline, 12 weeks
|
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Auditory Reaction Time of Dominant Hand by Newtest 1000 Timer
Time Frame: Baseline, 12 weeks
|
Baseline, 12 weeks
|
|
Auditory Reaction Time of Non-dominant Hand by Newtest 1000 Timer
Time Frame: Baseline, 12 weeks
|
Baseline, 12 weeks
|
|
Self-Perception of Sports Competence Assessed by Children and Youth Physical Self-perception Profile (CY-PSPP)
Time Frame: Baseline, 12 weeks
|
The scale "Children and Youth Physical Self Perception Profile (CY-PSPP)" assessed the children's self-percetion about sports competence subscale in both groups at the beginning and at the end of protocol.
The subscale was assessed by 6 questions with four ordinal levels (1-4) of response.
Minimum and maximum total scores change between 6 to 24 for the subscale.
Higher scores mean a better score.
|
Baseline, 12 weeks
|
Self-perception of Physical Condition Competence Assessed by Children and Youth Physical Self-perception Profile (CY-PSPP)
Time Frame: Baseline, 12 weeks
|
The scale "Children and Youth Physical Self Perception Profile (CY-PSPP)" assessed the children's self-percetion about physical condition competence subscale in both groups at the beginning and at the end of protocol.
The subscale was assessed by 6 questions with four ordinal levels (1-4) of response.
Minimum and maximum total scores change between 6 to 24 for the subscale.
Higher scores mean a better score.
|
Baseline, 12 weeks
|
Self-perception of Strength Competence Assessed by Children and Youth Physical Self-perception Profile (CY-PSPP)
Time Frame: Baseline, 12 weeks
|
The scale "Children and Youth Physical Self Perception Profile (CY-PSPP)" assessed the children's self-percetion about strength competence subscale in both groups at the beginning and at the end of protocol.
The subscale was assessed by 6 questions with four ordinal levels (1-4) of response.
Minimum and maximum total scores change between 6 to 24 for the subscale.
Higher scores mean a better score.
|
Baseline, 12 weeks
|
Self-perception of Body Attractiveness Assessed by Children and Youth Physical Self-perception Profile (CY-PSPP)
Time Frame: Baseline, 12 weeks
|
The scale "Children and Youth Physical Self Perception Profile (CY-PSPP)" assessed the children's self-percetion about body attractiveness subscale in both groups at the beginning and at the end of protocol.
The subscale was assessed by 6 questions with four ordinal levels (1-4) of response.
Minimum and maximum total scores change between 6 to 24 for the subscale.
Higher scores mean a better score.
|
Baseline, 12 weeks
|
Self-perception of Global Physical Self-worth Assessed by Children and Youth Physical Self-perception Profile (CY-PSPP)
Time Frame: Baseline, 12 weeks
|
The scale "Children and Youth Physical Self Perception Profile (CY-PSPP)" assessed the children's self-percetion about physical self-worth subscale in both groups at the beginning and at the end of protocol.
The subscale was assessed by 6 questions with four ordinal levels (1-4) of response.
Minimum and maximum total scores change between 6 to 24 for the subscale.
Higher scores mean a better score.
|
Baseline, 12 weeks
|
Self-perception of Global Self-worth Assessed by Children and Youth Physical Self-perception Profile (CY-PSPP)
Time Frame: Baseline, 12 weeks
|
The scale "Children and Youth Physical Self Perception Profile (CY-PSPP)" assessed the children's self-percetion about global self-worth subscale in both groups at the beginning and at the end of protocol.
The subscale was assessed by 6 questions with four ordinal levels (1-4) of response.
Minimum and maximum total scores change between 6 to 24 for the subscale.
Higher scores mean a better score.
|
Baseline, 12 weeks
|
Enjoyment Levels of Genders From Sports Category in the Game Group by Physical Activity Enjoyment Scale (PACES-SF)
Time Frame: After every game during 12 weeks
|
For Sports category, there were 5 games of boxing, tennis, golf, baseball, and bowling. Thus, each child was evaluated after every single game by five bipolar scale questions. Questions 1 and 4 were starting from positive to negative answers (left to right) and scored as 7-1. Scale scores were determined by calculating the mean. All scale scores were summed to calculate the Category score. The higher the score, the better the enjoyment in this category. Min-Max Sports Category scores were 11-25 for females and 17.8-26.2 for males. |
After every game during 12 weeks
|
Enjoyment Levels of Genders From Resort Category in the Game Group by Physical Activity
Time Frame: After every game during 12 weeks
|
For Resort category, there were 8 games of jet-skiing, water skiing, table tennis, basketball, swordplay, archery, canoeing and frisbee. Thus, each child was evaluated after every single game by five bipolar scale questions. Questions 1 and 4 were starting from positive to negative answers (left to right) and therefore scored as 7-1. Scale scores were determined by calculating the mean. All scale scores were summed to calculate the Category score. The higher the score, the better the enjoyment in this category. Min-Max Resort Category scores were 23.2-37 for females and 25.8-37.8 for males. |
After every game during 12 weeks
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Enjoyment Levels by Physical Activity of Genders From Balance Category in the Game Group
Time Frame: After every game during 12 weeks
|
For Balance category, there were 5 games of ski slalom, heading ball, balance bubble, ski jumping and penguin playing. Thus, each child was evaluated after every single game by five bipolar scale questions. Questions 1 and 4 were starting from positive to negative answers (left to right) and therefore scored as 7-1. Scale scores were determined by calculating the mean. All scale scores were summed to calculate the Category score. The higher the score, the better the enjoyment in this category. Min-Max Balance Category scores were 14.4-23.2 for females and 15-26.6 for males. |
After every game during 12 weeks
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Enjoyment Levels by Physical Activity of Genders From Aerobic Category in the Game Group
Time Frame: After every game during 12 weeks
|
For Aerobics category, there were 5 games of rhytmic boxing, hula-hoop, cycling, step, and run. Thus, each child was evaluated after every single game by five bipolar scale questions. Questions 1 and 4 were starting from positive to negative answers (left to right) and therefore scored as 7-1. Scale scores were determined by calculating the mean. All scale scores were summed to calculate the Category score. The higher the score, the better the enjoyment in this category. Min-Max Aerobics Category scores were 17.8-24 for females and 14.4-26.4 for males. |
After every game during 12 weeks
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Enjoyment Levels by Physical Activity of Genders From Training Category in the Game Group
Time Frame: After every game during 12 weeks
|
For Training category, there were 9 games of rhythm kung fu, snowball, turning ball, Segway circuit, perfect 10, skateboard, major, obstacle course and bicycle. Thus, each child was evaluated after every single game by five bipolar scale questions. Questions 1 and 4 were starting from positive to negative answers (left to right) and therefore scored as 7-1. Scale scores were determined by calculating the mean. All scale scores were summed to calculate the Category score. The higher the score, the better the enjoyment in this category. Min-Max Training Category scores were 31.6-41.8 for females and 29.2-45.2 for males. |
After every game during 12 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dilsad Coknaz, Abant Izzet Baysal University
Publications and helpful links
General Publications
- Kohl HW 3rd, Craig CL, Lambert EV, Inoue S, Alkandari JR, Leetongin G, Kahlmeier S; Lancet Physical Activity Series Working Group. The pandemic of physical inactivity: global action for public health. Lancet. 2012 Jul 21;380(9838):294-305. doi: 10.1016/S0140-6736(12)60898-8.
- Booth FW, Roberts CK, Laye MJ. Lack of exercise is a major cause of chronic diseases. Compr Physiol. 2012 Apr;2(2):1143-211. doi: 10.1002/cphy.c110025.
- Maddison R, Foley L, Mhurchu CN, Jull A, Jiang Y, Prapavessis H, Rodgers A, Vander Hoorn S, Hohepa M, Schaaf D. Feasibility, design and conduct of a pragmatic randomized controlled trial to reduce overweight and obesity in children: The electronic games to aid motivation to exercise (eGAME) study. BMC Public Health. 2009 May 19;9:146. doi: 10.1186/1471-2458-9-146.
- Martins C, Morgan L, Truby H. A review of the effects of exercise on appetite regulation: an obesity perspective. Int J Obes (Lond). 2008 Sep;32(9):1337-47. doi: 10.1038/ijo.2008.98. Epub 2008 Jul 8.
- Coknaz D, Mirzeoglu AD, Atasoy HI, Alkoy S, Coknaz H, Goral K. A digital movement in the world of inactive children: favourable outcomes of playing active video games in a pilot randomized trial. Eur J Pediatr. 2019 Oct;178(10):1567-1576. doi: 10.1007/s00431-019-03457-x. Epub 2019 Aug 30.
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012.16.02.545
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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