Body Weight Clinical Trial
— AVGAMEOfficial title:
A Digital Movement in the World of Inactive Children: Outcomes of Playing Active Video Games in a Pilot Randomized Trial
Verified date | April 2020 |
Source | Abant Izzet Baysal University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Abant Izzet Baysal University |
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04085861 -
Mental Health in Dancers; an Intervention Study
|
N/A | |
Active, not recruiting |
NCT02558920 -
Meta-analyses of Food Sources of Fructose-Containing Sugars and Obesity
|
||
Not yet recruiting |
NCT06026631 -
Lipidomic Characterization in Non-metastatic Breast Cancer Women Undergoing Surgery: a Pilot Study.
|
N/A | |
Completed |
NCT03850990 -
Effect of Gut-Cued Eating on BMI and Efficacy of Open-Label Placebo to Augment Weight Loss
|
N/A | |
Not yet recruiting |
NCT03601273 -
Bariatric Embolization Trial for the Obese Nonsurgical
|
Phase 1 | |
Completed |
NCT02899559 -
Messages and Plans to Increase Gym Utilization
|
N/A | |
Active, not recruiting |
NCT02557022 -
Meta Analysis of the Effect of a Low Glycemic Index Diet and Glycemic Load on Body Weight
|
N/A | |
Completed |
NCT02158130 -
Effects of Aerobic Exercise Detraining
|
N/A | |
Completed |
NCT02188251 -
A Study Investigating the Effects of Activamp on Body Weight, Fat Loss, and Metabolic Markers in Healthy Overweight Participants
|
Phase 2 | |
Completed |
NCT02402985 -
Comparison of a Plant Protein Diet to a Animal Protein Diet Emphasized in Type 2 Diabetics
|
N/A | |
Completed |
NCT01665339 -
Preload, Weight Management, Risk of Cardiovascular Disease
|
Phase 3 | |
Completed |
NCT01131871 -
Innovative Approaches to Diet, Exercise and Activity
|
Phase 2 | |
Completed |
NCT02395835 -
Methylation of the PPARg Promoter Region in Pregnancy
|
N/A | |
Completed |
NCT01170390 -
Oral Contraceptives and Body Mass Index
|
Phase 4 | |
Completed |
NCT00814554 -
Effectiveness Evaluation of Three Strategies of Promotion of Healthy Dietary and Physical Activity Behaviours to Prevent Weight Excess Among Teenagers
|
N/A | |
Completed |
NCT04901949 -
The Course of Acute Pancreatitis in Patients With Different BMI Groups
|
||
Active, not recruiting |
NCT03843424 -
Treatment Efforts Addressing Child Weight Management by Unifying Patients, Parents & Providers
|
N/A | |
Active, not recruiting |
NCT03575897 -
Serial Assessment of Body Fat Accrual in Very Preterm Infants
|
N/A | |
Active, not recruiting |
NCT05601804 -
TARGETing Healthy Weight Loss in the Context of Food Insecurity
|
||
Not yet recruiting |
NCT05004558 -
Effects of Remote-based Resistance Training on Cardiometabolic Risk Factors, Cognitive Function, and Quality of Life in Adults Living With Alzheimer's Disease and/or Related Dementias
|
N/A |