Active Videogames Against Obesity in Children

Physical Activity Clinical Trial

— VIDEOACTIVO  

Official title:

Active Video Games Against Obesity and Sedentarism in Children Between 9 and 11 Years Old: a Disruptive Proposal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04418713
• Other study ID #: DEP2017-85194-P
• Status: Completed
• Phase: N/A
• Start date: November 5, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2024
• Source: Universidad de Zaragoza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: December 31, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Fat
• Childhood Obesity
• Obesity
• Pediatric Obesity
• Physical Activity
• Sedentary Lifestyle

Intervention

Other:
• active video-games
An intervention with active video-games to increase physical activity and improve body composition

Locations

Country	Name	City	State
Spain	José Antonio Casajús Mallén	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Zaragoza

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in fat mass during 6 months evaluated by Dual energy X-ray absorptiometry	Fat mass is measured by dual X-ray photon absorptiometry (DXA) using the software and pediatric reference values (Hologic Explorer, Hologic Corp., Software Latest Version, Waltham, MA).	Change from baseline in fat mass at 6 months
Primary	Change in size during 6 months evaluated by a height rod to the nearest 0.1 cm (SECA 225, SECA, Hamburg, Germany).	Height is measured with a height rod to the nearest 0.1 cm (SECA 225, SECA, Hamburg, Germany),	Change from baseline in size at 6 months
Primary	Change in size during 6 months evaluated by a 0.1 kg precision bascule (SECA 861, SECA, Hamburg, Germany)	Weight of the children is measured by a 0.1 kg precision bascule (SECA 861, SECA, Hamburg, Germany)	Change from baseline in weight at 6 months
Primary	Change in waist and hip circumference during 6 months evaluated by an anthropometric tape following the ISAK protocol.	The waist and hip circumference are measured following the ISAK protocol and measurement technique with an anthropometric tape (Holtain).	Change from baseline in waist and hip circumference at 6 months
Primary	Change in height jump during 6 months evaluated by countermovement jump test	Jump is measured by calculating flight height during countermoving jumps (CMJ) with a Kistler force platform.	Change from baseline in countermovement jump at 6 months
Primary	Change in maximum manual pressure during 6 months evaluated by a manual dynamometry.	Maximum manual pressure force measured by a manual dynamometry is performed with a Takei-Grip dynamometer (Espana-Romero, 2010) from 5 to 100 kg adjusting the grip to the optimal measure to develop the greatest strength as described for boys and girls	Change from baseline in dynamometry at 6 months
Primary	Change in knee extension isometric strength during 6 months evaluated by a strain gage.	The isometric maximum force of quadriceps extension is evaluated by means of a strain gage anchored firmly to the wall and connected to a specific interface (MuscleLab); the force exerted by the subject for 10 seconds is measured and the maximum peak force is recorded.	Change from baseline in isometric knee extension strength at 6 months
Primary	Change in cardiorespiratory fitness during 6 months evaluated by a continuous progressive stress test	To assess cardiorespiratory resistance, a continuous progressive test will be carried out until exhaustion, with electrocardiographic control and breath-by-breath gas analysis to measure VO2max by a maximum test with gas analyzer (Oxycon Pro, Jaeger / Viasys, Germany).	Change from baseline in cardiorespiratory fitness at 6 months
Primary	Change in the level of physical activity during 6 months evaluated by accelerometry.	Accelerometer measures diferent intensities of physical activity during 1 week before and after the training with videogames	Change from baseline in physical activity at 6 months
Primary	Change in markers of inflammation and metabolic risk during 6 months evaluated by blood analysis	to evaluated the biochemical analysis	Change from baseline in markers of inflammation at 6 months
Primary	Change in systolic blood pressure during 6 months evaluated by sphygmomanometer	Systolic blood pressure are measured, in duplicate, at rest with a sphygmomanometer (Omron M3).	Change from baseline in systolic blood preasure at 6 months
Primary	Change in diastolic blood pressure during 6 months evaluated by sphygmomanometer.	Diastolic blood pressure are measured, in duplicate, at rest with a sphygmomanometer (Omron M3).	Change from baseline in diastolic blood pressure at 6 months