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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03720938
Other study ID # 2012.16.02.545
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2013
Est. completion date January 2020

Study information

Verified date April 2020
Source Abant Izzet Baysal University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 106
Est. completion date January 2020
Est. primary completion date May 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 13 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Active Video Games
Nintendo Wii® AVGs from sports, balance, aerobics, resort and training categories.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Abant Izzet Baysal University

References & Publications (4)

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. Review. — View 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. Review. — View 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. — View 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline, 12 weeks
Primary 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. Baseline, 12 weeks
Primary BMI Calculated as "Weight (kg) / Height (m^2)" Body Mass Index calculation of both groups before the games and after the games. Baseline, 12 weeks
Primary 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. Baseline, 12 weeks
Primary 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. Baseline, 12 weeks
Secondary 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. Baseline, 12 weeks
Secondary Visual Reaction Times of Non-dominant Hand by Newtest 1000 Timer Baseline, 12 weeks
Secondary Auditory Reaction Time of Dominant Hand by Newtest 1000 Timer Baseline, 12 weeks
Secondary Auditory Reaction Time of Non-dominant Hand by Newtest 1000 Timer Baseline, 12 weeks
Secondary 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. Baseline, 12 weeks
Secondary 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. Baseline, 12 weeks
Secondary 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. Baseline, 12 weeks
Secondary 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. Baseline, 12 weeks
Secondary 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. Baseline, 12 weeks
Secondary 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. Baseline, 12 weeks
Secondary 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.
After every game during 12 weeks
Secondary 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.
After every game during 12 weeks
Secondary 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.
After every game during 12 weeks
Secondary 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.
After every game during 12 weeks
Secondary 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.
After every game during 12 weeks
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