ObesityPhase 3NCT02214108
Effect of Physical Activity Through Interactive Video Games in Overweight Children
A Phase 3 study testing Nintendo Wii in people with Obesity and Overweight, run by Centro Pediatrico Albina de Patino at 1 site in Bolivia.
Trial summary
The purpose of this study is to determine the effect of interactive video game in management of overweight in children. The investigators will evaluate the effect of product versus standard physical activity. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Nintendo Wii
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBolivia
- Study dates
- Nov 2012to Dec 2015
- Phase
- Phase 3
- 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 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children aged 5-10 years with a diagnosis of overweight or obese (according to WHO criteria)
Who cannot join
- overweight or obese due other disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Physical Activity Trough Interactive Video Games in Overweight, Randomized, Controlled Study.
The purpose of this study is to determine the effect of interactive video game in management of overweight in children. The investigators will evaluate the effect of product versus standard physical activity.
Read the detailed description
Background. Child Overweight and obesity are a world public health problem, in low income countries is more. One difficulty in the management is the poor adherence to physical activity, some studies show that active video games could improve this.
Objective: Establish the effect of the introduction of active video game (Nintendo Wii) on fitness, anthropometry and adherence to treatment, as part of an intervention program for the management of childhood obesity in children over 5 years of age with obesity Methodology: A clinical trial, randomized and controlled. children between 5-10 years with a diagnosis of overweight or obese, were divided into two groups. (Wii group), received 3 weekly sessions of one hour of physical activity by an active video game, the other group (control group) received 3 weekly sessions of one hour of physical activity by static exercises.
- Conditions
- Obesity, Overweight
- Being tested
- Nintendo Wii
- Keywords
- BMI, Obesity, overweight, child, Physical activity
- Medical subject headings
- Obesity, Overweight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nintendo WiiOther
Also called active video games
Tennis, box and bowling on Nintendo Wii, 3 hours per week.
| Study group | Role | What they receive |
|---|---|---|
| Phisical activity with Nintendo Wii | Experimental | 3 hours of weekly of physical activity, divided in 1 hour interday with Nintendo WII. games applied: Wii Boxing, Wii Tennis; Wii Bowling Receives: Other: Nintendo Wii |
| phisical activity with phisiotherapist | No intervention | 3 hours of weekly physical activity, divided in 1 hour interday. applying cardiovascular and muscular endurance static exercises. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Mass Index
Measured: one month
Secondary outcomes (3)
change in weight
Measured: one month
change in physical endurance
Measured: one month
variations in serum lipids
Cholesterol, triglycerides.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2014 (estimated)
- Study startNov 2012
- Primary completionAug 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Pediatrico Albina de Patino
- Sponsor type
- University, hospital or other
- Collaborators
- University of Chile
- Responsible party
- Principal investigator, Giuseppe Grandy, Centro Pediatrico Albina de Patino
- Investigators
- Giuseppe Esteban Grandy Aranda, MSc, Study director, Centro de Pediatria Albina PatinoAlicia Ribero Nogales, MD, Principal investigator, Centro de Pediatria Albina PatinoGerardo Weisstaub, MSc, Study chair, Institute of Nutrition and Technology of Food.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02214108
- Sponsor's protocol ID
- protwii2013
- Status last verified
- Mar 2014
- First submitted
- 25 Jul 2014
- Last updated
- 4 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Physical Activity Trough Interactive Video Games in Overweight, Randomized, Controlled Study.
- ClinicalTrials.gov ID
- NCT02214108
- Acronym / sponsor ID
- protwii2013
- Conditions
- Obesity, Overweight
- Keywords
- BMI, Obesity, overweight, child, Physical activity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centro Pediatrico Albina de PatinoUniversity, hospital or other
- Collaborators
- University of Chile
- Study start
- Nov 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 12 Aug 2014 (estimated)
- 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.
The purpose of this study is to determine the effect of interactive video game in management of overweight in children. The investigators will evaluate the effect of product versus standard physical activity.
Detailed description
Background. Child Overweight and obesity are a world public health problem, in low income countries is more. One difficulty in the management is the poor adherence to physical activity, some studies show that active video games could improve this.
Objective: Establish the effect of the introduction of active video game (Nintendo Wii) on fitness, anthropometry and adherence to treatment, as part of an intervention program for the management of childhood obesity in children over 5 years of age with obesity Methodology: A clinical trial, randomized and controlled. children between 5-10 years with a diagnosis of overweight or obese, were divided into two groups. (Wii group), received 3 weekly sessions of one hour of physical activity by an active video game, the other group (control group) received 3 weekly sessions of one hour of physical activity by static exercises.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phisical activity with Nintendo Wii | Experimental | Other: Nintendo Wii3 hours of weekly of physical activity, divided in 1 hour interday with Nintendo WII. games applied: Wii Boxing, Wii Tennis; Wii Bowling |
| phisical activity with phisiotherapist | No intervention | –3 hours of weekly physical activity, divided in 1 hour interday. applying cardiovascular and muscular endurance static exercises. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children aged 5-10 years with a diagnosis of overweight or obese (according to WHO criteria)
Key exclusion criteria (1 listed)
- overweight or obese due other disease.
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 |
|---|---|---|
| Nintendo WiiAlso: active video gamesTennis, box and bowling on Nintendo Wii, 3 hours per week. | Other | Phisical activity with Nintendo Wii |
Primary outcome
Change in Body Mass Index
Time frame: one month
3 secondary outcomes
change in weight
Time frame: one month
change in physical endurance
Time frame: one month
variations in serum lipids
Time frame: 1 month
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 4 Mar 2016.
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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.
Giuseppe Esteban Grandy Aranda, MSc study director
Centro de Pediatria Albina Patino
Alicia Ribero Nogales, MD principal investigator
Centro de Pediatria Albina Patino
Gerardo Weisstaub, MSc study chair
Institute of Nutrition and Technology of Food.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nintendo Wii in people with Obesity and Overweight, run by Centro Pediatrico Albina de Patino at 1 site in Bolivia.
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 1 inclusion and 1 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 4 Mar 2016. 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 Bolivia. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Body Mass Index (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2016.