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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
Abant Izzet Baysal University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

8 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Being 8-13 years old
  2. Being preoccupied with technology
  3. Being physically inactive

Exclusion Criteria:

  1. Having circulatory, respiratory and musculoskeletal disease
  2. Having neuropsychiatric diseases
  3. History of syncope or seizures
  4. History of exercise induced anaphylaxis
  5. Morbid obesity
  6. 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

    First Posted
    October 22, 2018
    Last Updated
    April 19, 2020
    Sponsor
    Abant Izzet Baysal University
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    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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