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Completed

NCT Number: NCT04418713

Active Videogames Against Obesity in Children

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.

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Key information

Conditions

Childhood Obesity Behavior Body Fat Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Physical Activity Sedentary Behavior Sedentary Lifestyle Signs and Symptoms

Age range

9 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

José Antonio Casajús Mallén

Zaragoza, 50009, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

active video-games

Other

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

Primary outcomes

  1. Change in fat mass during 6 months evaluated by Dual energy X-ray absorptiometry

    Time frame: Change from baseline in fat mass at 6 months

    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).

  2. Change in size during 6 months evaluated by a height rod to the nearest 0.1 cm (SECA 225, SECA, Hamburg, Germany).

    Time frame: Change from baseline in size at 6 months

    Height is measured with a height rod to the nearest 0.1 cm (SECA 225, SECA, Hamburg, Germany),

  3. Change in size during 6 months evaluated by a 0.1 kg precision bascule (SECA 861, SECA, Hamburg, Germany)

    Time frame: Change from baseline in weight at 6 months

    Weight of the children is measured by a 0.1 kg precision bascule (SECA 861, SECA, Hamburg, Germany)

  4. Change in waist and hip circumference during 6 months evaluated by an anthropometric tape following the ISAK protocol.

    Time frame: Change from baseline in waist and hip circumference at 6 months

    The waist and hip circumference are measured following the ISAK protocol and measurement technique with an anthropometric tape (Holtain).

  5. Change in height jump during 6 months evaluated by countermovement jump test

    Time frame: Change from baseline in countermovement jump at 6 months

    Jump is measured by calculating flight height during countermoving jumps (CMJ) with a Kistler force platform.

  6. Change in maximum manual pressure during 6 months evaluated by a manual dynamometry.

    Time frame: Change from baseline in dynamometry at 6 months

    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

  7. Change in knee extension isometric strength during 6 months evaluated by a strain gage.

    Time frame: Change from baseline in isometric knee extension strength at 6 months

    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.

  8. Change in cardiorespiratory fitness during 6 months evaluated by a continuous progressive stress test

    Time frame: Change from baseline in cardiorespiratory fitness at 6 months

    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).

  9. Change in the level of physical activity during 6 months evaluated by accelerometry.

    Time frame: Change from baseline in physical activity at 6 months

    Accelerometer measures diferent intensities of physical activity during 1 week before and after the training with videogames

  10. Change in markers of inflammation and metabolic risk during 6 months evaluated by blood analysis

    Time frame: Change from baseline in markers of inflammation at 6 months

    to evaluated the biochemical analysis

  11. Change in systolic blood pressure during 6 months evaluated by sphygmomanometer

    Time frame: Change from baseline in systolic blood preasure at 6 months

    Systolic blood pressure are measured, in duplicate, at rest with a sphygmomanometer (Omron M3).

  12. Change in diastolic blood pressure during 6 months evaluated by sphygmomanometer.

    Time frame: Change from baseline in diastolic blood pressure at 6 months

    Diastolic blood pressure are measured, in duplicate, at rest with a sphygmomanometer (Omron M3).

Sponsors and collaborators

Lead sponsor

Universidad de Zaragoza

Other

Registry information

Official study title

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

Acronym: VIDEOACTIVO

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 5, 2020
Registry last updated
Jan 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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