Clinical trial NCT03720938: Effects of Active Video Games in Physically Inactive Children
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
Overall status: COMPLETED
Phase: NA
Conditions: Self-Perception
Body Weight
Keywords: inactive children
active video games
physical fitness
self-perception
enjoyment
obesity
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2018-10-26
Enrollment: 106
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight in Kilograms
timeFrame: Baseline, 12 weeks
measure: Weight z Score
timeFrame: Baseline, 12 weeks
measure: BMI Calculated as "Weight (kg) / Height (m^2)"
timeFrame: Baseline, 12 weeks
measure: BMI z Score
timeFrame: Baseline, 12 weeks
measure: Body Fat Percentage as Determined by Siri Formula From Skinfold Thicknesses
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Visual Reaction Times of Dominant Hand by Newtest 1000 Timer
timeFrame: Baseline, 12 weeks
measure: Visual Reaction Times of Non-dominant Hand by Newtest 1000 Timer
timeFrame: Baseline, 12 weeks
measure: Auditory Reaction Time of Dominant Hand by Newtest 1000 Timer
timeFrame: Baseline, 12 weeks
measure: Auditory Reaction Time of Non-dominant Hand by Newtest 1000 Timer
timeFrame: Baseline, 12 weeks
measure: Self-Perception of Sports Competence Assessed by Children and Youth Physical Self-perception Profile (CY-PSPP)
timeFrame: Baseline, 12 weeks
measure: Self-perception of Physical Condition Competence Assessed by Children and Youth Physical Self-perception Profile (CY-PSPP)
timeFrame: Baseline, 12 weeks
measure: Self-perception of Strength Competence Assessed by Children and Youth Physical Self-perception Profile (CY-PSPP)
timeFrame: Baseline, 12 weeks
measure: Self-perception of Body Attractiveness Assessed by Children and Youth Physical Self-perception Profile (CY-PSPP)
timeFrame: Baseline, 12 weeks
measure: Self-perception of Global Physical Self-worth Assessed by Children and Youth Physical Self-perception Profile (CY-PSPP)
timeFrame: Baseline, 12 weeks
measure: Self-perception of Global Self-worth Assessed by Children and Youth Physical Self-perception Profile (CY-PSPP)
timeFrame: Baseline, 12 weeks
measure: Enjoyment Levels of Genders From Sports Category in the Game Group by Physical Activity Enjoyment Scale (PACES-SF)
timeFrame: After every game during 12 weeks
measure: Enjoyment Levels of Genders From Resort Category in the Game Group by Physical Activity
timeFrame: After every game during 12 weeks
measure: Enjoyment Levels by Physical Activity of Genders From Balance Category in the Game Group
timeFrame: After every game during 12 weeks
measure: Enjoyment Levels by Physical Activity of Genders From Aerobic Category in the Game Group
timeFrame: After every game during 12 weeks
measure: Enjoyment Levels by Physical Activity of Genders From Training Category in the Game Group
timeFrame: After every game during 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Abant Izzet Baysal University
name: Dilsad Coknaz
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.