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Active Videogames Against Obesity in Children (VIDEOACTIVO)

Primary Purpose

Childhood Obesity, Physical Activity, Sedentary Lifestyle

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
active video-games
Sponsored by
Universidad de Zaragoza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity focused on measuring Obesity, Sedentary Lifestyle, Physical Activity, Childhood Obesity, Exergames, Body Composition, Physical Fitness, Cardiometabolic Risk

Eligibility Criteria

9 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • José Antonio Casajús MallénRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

exercise group with active video-games

control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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 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 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 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 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 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 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 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 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 in markers of inflammation and metabolic risk during 6 months evaluated by blood analysis
to evaluated the biochemical analysis
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 in diastolic blood pressure during 6 months evaluated by sphygmomanometer.
Diastolic blood pressure are measured, in duplicate, at rest with a sphygmomanometer (Omron M3).

Secondary Outcome Measures

Change in nutrition habits during 6 months evaluated by a questionnaire
A questionnaire are used, to evaluated the nutritional habits
Change in pubertal development during 6 months evaluated by Tanner stages.
An experienced physician directly evaluates pubertal development by participants' Tanner stages.

Full Information

First Posted
March 13, 2019
Last Updated
June 4, 2020
Sponsor
Universidad de Zaragoza
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1. Study Identification

Unique Protocol Identification Number
NCT04418713
Brief Title
Active Videogames Against Obesity in Children
Acronym
VIDEOACTIVO
Official Title
Active Video Games Against Obesity and Sedentarism in Children Between 9 and 11 Years Old: a Disruptive Proposal
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 5, 2018 (Actual)
Primary Completion Date
June 30, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Zaragoza

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: To evaluate the effects of an active video game program on cardiometabolic risk in overweight/obese children to identify the effect of this intervention on physical fitness 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity, Physical Activity, Sedentary Lifestyle, Body Fat
Keywords
Obesity, Sedentary Lifestyle, Physical Activity, Childhood Obesity, Exergames, Body Composition, Physical Fitness, Cardiometabolic Risk

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
exercise group with active video-games
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
no physical intevention will be provided, but it will be included some sessions on nutritional advice.
Intervention Type
Other
Intervention Name(s)
active video-games
Intervention Description
An intervention with active video-games to increase physical activity and improve body composition
Primary Outcome Measure Information:
Title
Change in fat mass during 6 months evaluated by Dual energy X-ray absorptiometry
Description
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).
Time Frame
Change from baseline in fat mass at 6 months
Title
Change in size during 6 months evaluated by a height rod to the nearest 0.1 cm (SECA 225, SECA, Hamburg, Germany).
Description
Height is measured with a height rod to the nearest 0.1 cm (SECA 225, SECA, Hamburg, Germany),
Time Frame
Change from baseline in size at 6 months
Title
Change in size during 6 months evaluated by a 0.1 kg precision bascule (SECA 861, SECA, Hamburg, Germany)
Description
Weight of the children is measured by a 0.1 kg precision bascule (SECA 861, SECA, Hamburg, Germany)
Time Frame
Change from baseline in weight at 6 months
Title
Change in waist and hip circumference during 6 months evaluated by an anthropometric tape following the ISAK protocol.
Description
The waist and hip circumference are measured following the ISAK protocol and measurement technique with an anthropometric tape (Holtain).
Time Frame
Change from baseline in waist and hip circumference at 6 months
Title
Change in height jump during 6 months evaluated by countermovement jump test
Description
Jump is measured by calculating flight height during countermoving jumps (CMJ) with a Kistler force platform.
Time Frame
Change from baseline in countermovement jump at 6 months
Title
Change in maximum manual pressure during 6 months evaluated by a manual dynamometry.
Description
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
Time Frame
Change from baseline in dynamometry at 6 months
Title
Change in knee extension isometric strength during 6 months evaluated by a strain gage.
Description
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.
Time Frame
Change from baseline in isometric knee extension strength at 6 months
Title
Change in cardiorespiratory fitness during 6 months evaluated by a continuous progressive stress test
Description
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).
Time Frame
Change from baseline in cardiorespiratory fitness at 6 months
Title
Change in the level of physical activity during 6 months evaluated by accelerometry.
Description
Accelerometer measures diferent intensities of physical activity during 1 week before and after the training with videogames
Time Frame
Change from baseline in physical activity at 6 months
Title
Change in markers of inflammation and metabolic risk during 6 months evaluated by blood analysis
Description
to evaluated the biochemical analysis
Time Frame
Change from baseline in markers of inflammation at 6 months
Title
Change in systolic blood pressure during 6 months evaluated by sphygmomanometer
Description
Systolic blood pressure are measured, in duplicate, at rest with a sphygmomanometer (Omron M3).
Time Frame
Change from baseline in systolic blood preasure at 6 months
Title
Change in diastolic blood pressure during 6 months evaluated by sphygmomanometer.
Description
Diastolic blood pressure are measured, in duplicate, at rest with a sphygmomanometer (Omron M3).
Time Frame
Change from baseline in diastolic blood pressure at 6 months
Secondary Outcome Measure Information:
Title
Change in nutrition habits during 6 months evaluated by a questionnaire
Description
A questionnaire are used, to evaluated the nutritional habits
Time Frame
Change from baseline in nutrition habits at 6 months
Title
Change in pubertal development during 6 months evaluated by Tanner stages.
Description
An experienced physician directly evaluates pubertal development by participants' Tanner stages.
Time Frame
Change from baseline in pubertal development at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
José Antonio Casajús Mallén, PhD MD
Phone
876553755
Ext
+34
Email
joseant@unizar.es
Facility Information:
Facility Name
José Antonio Casajús Mallén
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José Antonio Casajús Mallén, PhD MD
Phone
876553755
Ext
+34
Email
joseant@unizar.es
First Name & Middle Initial & Last Name & Degree
José Antonio Casajús Mallén
First Name & Middle Initial & Last Name & Degree
Alejandro González de Agüero Lafuente

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35471240
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.
Results Reference
derived

Learn more about this trial

Active Videogames Against Obesity in Children

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