Active Videogames Against Obesity in Children

NCT04418713 | Completed

• 1 other identifier: DEP2017-85194-P
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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

Conditions

Childhood Obesity; Physical Activity; Sedentary Lifestyle; Body Fat

Keywords

Obesity; Sedentary Lifestyle; Physical Activity; Childhood Obesity; Exergames; Body Composition; Physical Fitness; Cardiometabolic Risk

Outcome Measures

Primary Outcomes (12)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

exercise group with active video-games

EXPERIMENTAL

exergaming exercise: A combination of traditional exercise and exercise through active video games performed 3 days a week for one hour during 7 months. As well, it will be including some session about nutritional advice.

Other: active video-games

control group

NO INTERVENTION

no physical intevention will be provided, but it will be included some sessions on nutritional advice.

Interventions

active video-games OTHER

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

exercise group with active video-games

Eligibility Criteria

• Age: 9 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Zaragoza: lead

Study Sites (1)

José Antonio Casajús Mallén

Zaragoza, 50009, Spain

Location

Related Publications (2)

• Comeras-Chueca C, Villalba-Heredia L, Lozano-Berges G, Matute-Llorente A, Marin-Puyalto J, Vicente-Rodriguez G, Casajus JA, Gonzalez-Aguero A. High muscular fitness level may positively affect bone strength and body composition in children with overweight and obesity. Arch Osteoporos. 2024 Jun 10;19(1):47. doi: 10.1007/s11657-024-01405-3.

  PMID: 38856950 DERIVED

• 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.

  PMID: 35471240 DERIVED

MeSH Terms

Conditions

Pediatric Obesity; Motor Activity; Sedentary Behavior; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: June 5, 2020
• Study Start: November 5, 2018
• Primary Completion: June 30, 2021
• Study Completion: December 31, 2021
• Last Updated: January 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)