Effects of Active Video Games in Physically Inactive Children (AVGAME)
Primary Purpose
Self-Perception, Body Weight
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Active Video Games
Sponsored by
About this trial
This is an interventional prevention trial for Self-Perception focused on measuring inactive children, active video games, physical fitness, self-perception, enjoyment, obesity
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Group
Intervention Group
Arm Description
Physically inactive children who did not play AVGs.
Physically inactive children who played alternately Nintendo Wii® active video games for 50-60 min, 3 days a week, 12 weeks, in laboratory environment.
Outcomes
Primary Outcome Measures
Weight in Kilograms
Weight measured to the nearest 0.01 kg by Seca 767 scale. The first before the games, the second after the games.
Weight z Score
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.
BMI Calculated as "Weight (kg) / Height (m^2)"
Body Mass Index calculation of both groups before the games and after the games.
BMI z Score
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.
Body Fat Percentage as Determined by Siri Formula From Skinfold Thicknesses
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.
Secondary Outcome Measures
Visual Reaction Times of Dominant Hand by Newtest 1000 Timer
Determination of visual reaction times after games in intervention groups, and control groups. First before the games, second after the games.
Visual Reaction Times of Non-dominant Hand by Newtest 1000 Timer
Auditory Reaction Time of Dominant Hand by Newtest 1000 Timer
Auditory Reaction Time of Non-dominant Hand by Newtest 1000 Timer
Self-Perception of Sports Competence Assessed by Children and Youth Physical Self-perception Profile (CY-PSPP)
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.
Self-perception of Physical Condition Competence Assessed by Children and Youth Physical Self-perception Profile (CY-PSPP)
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.
Self-perception of Strength Competence Assessed by Children and Youth Physical Self-perception Profile (CY-PSPP)
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.
Self-perception of Body Attractiveness Assessed by Children and Youth Physical Self-perception Profile (CY-PSPP)
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.
Self-perception of Global Physical Self-worth Assessed by Children and Youth Physical Self-perception Profile (CY-PSPP)
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.
Self-perception of Global Self-worth Assessed by Children and Youth Physical Self-perception Profile (CY-PSPP)
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.
Enjoyment Levels of Genders From Sports Category in the Game Group by Physical Activity Enjoyment Scale (PACES-SF)
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.
Enjoyment Levels of Genders From Resort Category in the Game Group by Physical Activity
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.
Enjoyment Levels by Physical Activity of Genders From Balance Category in the Game Group
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.
Enjoyment Levels by Physical Activity of Genders From Aerobic Category in the Game Group
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.
Enjoyment Levels by Physical Activity of Genders From Training Category in the Game Group
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.
Full Information
NCT ID
NCT03720938
First Posted
October 22, 2018
Last Updated
April 19, 2020
Sponsor
Abant Izzet Baysal University
1. Study Identification
Unique Protocol Identification Number
NCT03720938
Brief Title
Effects of Active Video Games in Physically Inactive Children
Acronym
AVGAME
Official Title
A Digital Movement in the World of Inactive Children: Outcomes of Playing Active Video Games in a Pilot Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
February 2013 (Actual)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
January 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abant Izzet Baysal University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Inactivity was reported to be high in children and considered to be the fourth common cause of death in all ages. The reason for children is usually the increasing indoor use of sedentary screen time. Active Video Games (AVG) have recently been introduced for decreasing the sedentary time for children and directing them to physical activity (PA) at home.The aim of this study is to show the quantitative effect of games on physical fitness parameters like weight, body mass index (BMI) and fat ratio (FR). The study also aims at the factors for motivation or continuance of the games as self-perception and enjoyment levels together with qualitative effects of games on satisfaction and attitude changes in inactive children.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Self-Perception, Body Weight
Keywords
inactive children, active video games, physical fitness, self-perception, enjoyment, obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Physically inactive children who did not play AVGs.
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Physically inactive children who played alternately Nintendo Wii® active video games for 50-60 min, 3 days a week, 12 weeks, in laboratory environment.
Intervention Type
Other
Intervention Name(s)
Active Video Games
Intervention Description
Nintendo Wii® AVGs from sports, balance, aerobics, resort and training categories.
Primary Outcome Measure Information:
Title
Weight in Kilograms
Description
Weight measured to the nearest 0.01 kg by Seca 767 scale. The first before the games, the second after the games.
Time Frame
Baseline, 12 weeks
Title
Weight z Score
Description
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.
Time Frame
Baseline, 12 weeks
Title
BMI Calculated as "Weight (kg) / Height (m^2)"
Description
Body Mass Index calculation of both groups before the games and after the games.
Time Frame
Baseline, 12 weeks
Title
BMI z Score
Description
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.
Time Frame
Baseline, 12 weeks
Title
Body Fat Percentage as Determined by Siri Formula From Skinfold Thicknesses
Description
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.
Time Frame
Baseline, 12 weeks
Secondary Outcome Measure Information:
Title
Visual Reaction Times of Dominant Hand by Newtest 1000 Timer
Description
Determination of visual reaction times after games in intervention groups, and control groups. First before the games, second after the games.
Time Frame
Baseline, 12 weeks
Title
Visual Reaction Times of Non-dominant Hand by Newtest 1000 Timer
Time Frame
Baseline, 12 weeks
Title
Auditory Reaction Time of Dominant Hand by Newtest 1000 Timer
Time Frame
Baseline, 12 weeks
Title
Auditory Reaction Time of Non-dominant Hand by Newtest 1000 Timer
Time Frame
Baseline, 12 weeks
Title
Self-Perception of Sports Competence Assessed by Children and Youth Physical Self-perception Profile (CY-PSPP)
Description
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.
Time Frame
Baseline, 12 weeks
Title
Self-perception of Physical Condition Competence Assessed by Children and Youth Physical Self-perception Profile (CY-PSPP)
Description
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.
Time Frame
Baseline, 12 weeks
Title
Self-perception of Strength Competence Assessed by Children and Youth Physical Self-perception Profile (CY-PSPP)
Description
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.
Time Frame
Baseline, 12 weeks
Title
Self-perception of Body Attractiveness Assessed by Children and Youth Physical Self-perception Profile (CY-PSPP)
Description
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.
Time Frame
Baseline, 12 weeks
Title
Self-perception of Global Physical Self-worth Assessed by Children and Youth Physical Self-perception Profile (CY-PSPP)
Description
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.
Time Frame
Baseline, 12 weeks
Title
Self-perception of Global Self-worth Assessed by Children and Youth Physical Self-perception Profile (CY-PSPP)
Description
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.
Time Frame
Baseline, 12 weeks
Title
Enjoyment Levels of Genders From Sports Category in the Game Group by Physical Activity Enjoyment Scale (PACES-SF)
Description
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.
Time Frame
After every game during 12 weeks
Title
Enjoyment Levels of Genders From Resort Category in the Game Group by Physical Activity
Description
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.
Time Frame
After every game during 12 weeks
Title
Enjoyment Levels by Physical Activity of Genders From Balance Category in the Game Group
Description
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.
Time Frame
After every game during 12 weeks
Title
Enjoyment Levels by Physical Activity of Genders From Aerobic Category in the Game Group
Description
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.
Time Frame
After every game during 12 weeks
Title
Enjoyment Levels by Physical Activity of Genders From Training Category in the Game Group
Description
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.
Time Frame
After every game during 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dilsad Coknaz
Organizational Affiliation
Abant Izzet Baysal University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22818941
Citation
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.
Results Reference
background
PubMed Identifier
23798298
Citation
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.
Results Reference
background
PubMed Identifier
19450288
Citation
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.
Results Reference
background
PubMed Identifier
18607378
Citation
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.
Results Reference
background
PubMed Identifier
31471690
Citation
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.
Results Reference
derived
Links:
URL
http://www.who.int/dietphysicalactivity/physical_activity_intensity/en/
Description
Global Strategy on Diet, Physical Activity and Health
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Effects of Active Video Games in Physically Inactive Children
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