Childhood ObesityVIDEOACTIVONCT04418713
Active Videogames Against Obesity in Children
A study testing active video-games in people with Childhood Obesity and Physical Activity, run by Universidad de Zaragoza at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 9 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity, Physical Activity, Sedentary Lifestyle
- What is being tested?
- active video-games
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteSpain
- Study dates
- 5 Nov 2018to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children with obesity and overweight
- children with ages between 9-11 years old
- children in tanner stage I ó II
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Active Video Games Against Obesity and Sedentarism in Children Between 9 and 11 Years Old: a Disruptive Proposal
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.
Read the 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.
- Conditions
- Childhood Obesity, Physical Activity, Sedentary Lifestyle, Body Fat
- Being tested
- active video-games
- Keywords
- Obesity, Sedentary Lifestyle, Physical Activity, Childhood Obesity, Exergames, Body Composition, Physical Fitness, Cardiometabolic Risk
- Medical subject headings
- Pediatric Obesity, Motor Activity, Sedentary Behavior, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active video-gamesOther
An intervention with active video-games to increase physical activity and improve body composition
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: active video-games |
| control group | No intervention | no physical intevention will be provided, but it will be included some sessions on nutritional advice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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),
Measured: 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)
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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
Measured: 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).
Measured: 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).
Measured: Change from baseline in diastolic blood pressure at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start5 Nov 2018
- Primary completion30 Jun 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José A. Casajús, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04418713
- Sponsor's protocol ID
- DEP2017-85194-P
- Acronym
- VIDEOACTIVO
- Status last verified
- Jan 2024
- First submitted
- 13 Mar 2019
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38856950Comeras-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.
PubMed 35471240
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Video Games Against Obesity and Sedentarism in Children Between 9 and 11 Years Old: a Disruptive Proposal
- ClinicalTrials.gov ID
- NCT04418713
- Acronym / sponsor ID
- VIDEOACTIVO / DEP2017-85194-P
- Conditions
- Childhood Obesity, Physical Activity, Sedentary Lifestyle, Body Fat
- Keywords
- Obesity, Sedentary Lifestyle, Physical Activity, Childhood Obesity, Exergames, Body Composition, Physical Fitness, Cardiometabolic Risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise group with active video-games | Experimental | Other: active video-gamesexergaming 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. |
| control group | No intervention | –no physical intevention will be provided, but it will be included some sessions on nutritional advice. |
Who may qualify
- Ages
- 9 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children with obesity and overweight
- children with ages between 9-11 years old
- children in tanner stage I ó II
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active video-gamesAn intervention with active video-games to increase physical activity and improve body composition | Other | exercise group with active video-games |
Primary outcome
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).
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),
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)
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).
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.
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
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.
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).
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
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
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Derived from this study: PubMed 38856950Comeras-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.
- Derived from this study: PubMed 35471240Comeras-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.
- Individual participant dataSharing planned: No
Related trials for Childhood Obesity
Enrolling by invitation
Impact of a Playful Family Education Strategy With ICT on Childhood Obesity Prevention
Pediatric Obesity, Childhood Obesity
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruiting
Growing Healthy Children and Families in Rural Arkansas
Pediatric Obesity, Health Behavior, Risky
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active video-games in people with Childhood Obesity and Physical Activity, run by Universidad de Zaragoza at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04418713, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024.