Clinical trial NCT04418713: Active Videogames Against Obesity in Children
Official title: Active Video Games Against Obesity and Sedentarism in Children Between 9 and 11 Years Old: a Disruptive Proposal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Physical Activity
Sedentary Lifestyle
Body Fat
Keywords: Obesity
Sedentary Lifestyle
Physical Activity
Childhood Obesity
Exergames
Body Composition
Physical Fitness
Cardiometabolic Risk
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
First posted: 2020-06-05
Enrollment: 92
Sex: ALL
Minimum age (years): 9
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Active video games are presented as an exercise option for children with little interest in traditional sports. The main objectives of this study are:

1. To evaluate the effects of an active video game program on cardiometabolic risk in overweight/obese children
2. to identify the effect of this intervention on physical fitness
3. to study possible changes in the sedentary lifestyles of children after the exercise program.

This is a randomized crossover study, with 2 intervention periods of 9 months each, and a 3-month period of washing. Ninetytwo children between 9 and 11 years old who are overweight or obese will be included and randomly assigned to one of the 2 homogeneous groups (control-intervention). Both groups will receive education in healthy lifestyles, and the intervention group will also follow a physical exercise program with active video games (3-4 days/week). The sessions will last between 30 and 45 minutes and will include different moderate-vigorous aerobic activities and muscular strength exercises. Body composition, physical fitness, levels of leptin, adiponectin and visfatin, lipid and ferric profiles, and markers of inflammation and metabolic risk such as insulin resistance, TNF-α, CRP, ALT, AST, gamma-GT and IL-6will be measured before and after the intervention. In addition, dietary habits (24h recalls), physical activity (accelerometers), blood pressure, waist and neck circumference, and pubertal development will be also assessed.

Detailed description: Childhood obesity is one of the main problems in developed societies, and entails enormous expenditure for the National Health System. In addition, childhood obesity is strongly associated with adult obesity and with all types of cardiovascular and metabolic pathologies. Physical exercise has been shown to be the great non-pharmacological enemy of both childhood and adult obesity, however sport practice and adherence to it is not easy in the overweight/obese population. In this context, active video games are presented as an exercise option for children with little interest in traditional sports. The main objectives of this study are: (1) To evaluate the effects of an active video game program on cardiometabolic risk in overweight/obese children; (2) to identify the effect of this intervention on physical fitness and (3) to study possible changes in the sedentary lifestyles of children after the exercise program.

This is a randomized crossover study, with 2 intervention periods of 9 months each, and a 3-month period of washing. Ninetytwo children between 9 and 11 years old who are overweight or obese will be included and randomly assigned to one of the 2 homogeneous groups (control-intervention). Both groups will receive education in healthy lifestyles, and the intervention group will also follow a physical exercise program with active video games (3-4 days/week). The sessions will last between 30 and 45 minutes and will include different moderate-vigorous aerobic activities and muscular strength exercises. Body composition, physical fitness, levels of leptin, adiponectin and visfatin, lipid and ferric profiles, and markers of inflammation and metabolic risk such as insulin resistance, TNF-α, CRP, ALT, AST, gamma-GT and IL-6will be measured before and after the intervention. In addition, dietary habits (24h recalls), physical activity (accelerometers), blood pressure, waist and neck circumference, and pubertal development will be also assessed.

Eligibility criteria: Inclusion Criteria:

* children with obesity and overweight
* children with ages between 9-11 years old
* children in tanner stage I ó II

Exclusion Criteria:

* to take drugs that can affect the measurements
* menarche in girls
* contraindications or pathologies associated with exercise
* regular attendance at extracurricular activities of high energy expenditure
* diet

Primary outcomes:
measure: Change in fat mass during 6 months evaluated by Dual energy X-ray absorptiometry
timeFrame: Change from baseline in fat mass at 6 months
measure: Change in size during 6 months evaluated by a height rod to the nearest 0.1 cm (SECA 225, SECA, Hamburg, Germany).
timeFrame: Change from baseline in size at 6 months
measure: Change in size during 6 months evaluated by a 0.1 kg precision bascule (SECA 861, SECA, Hamburg, Germany)
timeFrame: Change from baseline in weight at 6 months
measure: Change in waist and hip circumference during 6 months evaluated by an anthropometric tape following the ISAK protocol.
timeFrame: Change from baseline in waist and hip circumference at 6 months
measure: Change in height jump during 6 months evaluated by countermovement jump test
timeFrame: Change from baseline in countermovement jump at 6 months
measure: Change in maximum manual pressure during 6 months evaluated by a manual dynamometry.
timeFrame: Change from baseline in dynamometry at 6 months
measure: Change in knee extension isometric strength during 6 months evaluated by a strain gage.
timeFrame: Change from baseline in isometric knee extension strength at 6 months
measure: Change in cardiorespiratory fitness during 6 months evaluated by a continuous progressive stress test
timeFrame: Change from baseline in cardiorespiratory fitness at 6 months
measure: Change in the level of physical activity during 6 months evaluated by accelerometry.
timeFrame: Change from baseline in physical activity at 6 months
measure: Change in markers of inflammation and metabolic risk during 6 months evaluated by blood analysis
timeFrame: Change from baseline in markers of inflammation at 6 months
measure: Change in systolic blood pressure during 6 months evaluated by sphygmomanometer
timeFrame: Change from baseline in systolic blood preasure at 6 months
measure: Change in diastolic blood pressure during 6 months evaluated by sphygmomanometer.
timeFrame: Change from baseline in diastolic blood pressure at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: José Antonio Casajús Mallén
Study officials:
References:
citation: Comeras-Chueca C, Villalba-Heredia L, Perez-Lasierra JL, Lozano-Berges G, Matute-Llorente A, Vicente-Rodriguez G, Casajus JA, Gonzalez-Aguero A. Effect of an Active Video Game Intervention Combined With Multicomponent Exercise for Cardiorespiratory Fitness in Children With Overweight and Obesity: Randomized Controlled Trial. JMIR Serious Games. 2022 May 24;10(2):e33782. doi: 10.2196/33782.