Active Videogames Against Obesity in Children

NCT ID: NCT04418713

Last Updated: 2024-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-05

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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Childhood Obesity Physical Activity Sedentary Lifestyle Body Fat

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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exercise group with active video-games

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.

Group Type EXPERIMENTAL

active video-games

Intervention Type OTHER

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

control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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active video-games

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

9 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad de Zaragoza

OTHER

Sponsor Role lead

Responsible Party

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José A. Casajús

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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José Antonio Casajús Mallén

Zaragoza, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 38856950 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35471240 (View on PubMed)

Other Identifiers

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DEP2017-85194-P

Identifier Type: -

Identifier Source: org_study_id

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