NCT03720938

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 26, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
4 months until next milestone

Results Posted

Study results publicly available

April 29, 2020

Completed
Last Updated

April 29, 2020

Status Verified

April 1, 2020

Enrollment Period

3 months

First QC Date

October 22, 2018

Results QC Date

February 28, 2020

Last Update Submit

April 19, 2020

Conditions

Keywords

inactive childrenactive video gamesphysical fitnessself-perceptionenjoymentobesity

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (15)

  • Visual Reaction Times of Dominant Hand by Newtest 1000 Timer

    Baseline, 12 weeks

  • Visual Reaction Times of Non-dominant Hand by Newtest 1000 Timer

    Baseline, 12 weeks

  • Auditory Reaction Time of Dominant Hand by Newtest 1000 Timer

    Baseline, 12 weeks

  • Auditory Reaction Time of Non-dominant Hand by Newtest 1000 Timer

    Baseline, 12 weeks

  • Self-Perception of Sports Competence Assessed by Children and Youth Physical Self-perception Profile (CY-PSPP)

    Baseline, 12 weeks

  • +10 more secondary outcomes

Study Arms (2)

Control Group

NO INTERVENTION

Physically inactive children who did not play AVGs.

Intervention Group

EXPERIMENTAL

Physically inactive children who played alternately Nintendo Wii® active video games for 50-60 min, 3 days a week, 12 weeks, in laboratory environment.

Other: Active Video Games

Interventions

Nintendo Wii® AVGs from sports, balance, aerobics, resort and training categories.

Intervention Group

Eligibility Criteria

Age8 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Being 8-13 years old
  • Being preoccupied with technology
  • Being physically inactive

You may not qualify if:

  • Having circulatory, respiratory and musculoskeletal disease
  • Having neuropsychiatric diseases
  • History of syncope or seizures
  • History of exercise induced anaphylaxis
  • Morbid obesity
  • Short stature

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 22818941BACKGROUND
  • 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.

    PMID: 23798298BACKGROUND
  • 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.

    PMID: 19450288BACKGROUND
  • 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.

    PMID: 18607378BACKGROUND
  • 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.

Related Links

MeSH Terms

Conditions

Body WeightObesity

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Limitations and Caveats

Conforming strictly to the rules of CONSORT extension for such "well controlled" studies when clustering with huge numbers of clusters without the risk of contamination might be impossible and unnecessary in small research areas like the city, Bolu.

Results Point of Contact

Title
Dr. Halil Ibrahim Atasoy
Organization
Abant Izzet Baysal University

Study Officials

  • Dilsad Coknaz

    Abant Izzet Baysal University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 22, 2018

First Posted

October 26, 2018

Study Start

February 1, 2013

Primary Completion

May 1, 2013

Study Completion

January 1, 2020

Last Updated

April 29, 2020

Results First Posted

April 29, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share