Passive Video Games (PVG)NCT01912300
Nutritional Adaptations to Physical or Sedentary Activities in Youth
A study testing experimental condition: Passvice Video game; Avtive Video game; Exercise in people with Passive Video Games (PVG) and Active Video Games (AVG), run by Université Blaise Pascal, Clermont-Ferrand at 1 site in France.
Trial summary
Sedentary behaviors have been shown to increase food consumption among youth and adults. The recent active video games devices have been suggested to compensate for the increased energy intake they induce by the increased energy expenditure they generate. Read more about this study
- Who is it for?
- Ages 12 to 15 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Passive Video Games (PVG), Active Video Games (AVG), Exercise (EX)
- What is being tested?
- experimental condition: Passvice Video game; Avtive Video game; Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2013to Jul 2014
- 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 12 to 15 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- male
- 12-15 years old
- BMI defining obesity (Cole et al., 2000)
- Not being under diet restriction
- Information and consent forms have to be signed by the adolescent and his legal representative
- being registered to the national social security system
Who cannot join
- Being under medication
- contraindication to exercise
- smokers
- dieting
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutritional Adaptation to Contemporary Sedentary Behaviors and Physical Exercise in Youth: Effect of Weight Status
Sedentary behaviors have been shown to increase food consumption among youth and adults. The recent active video games devices have been suggested to compensate for the increased energy intake they induce by the increased energy expenditure they generate. To date no study has been conducted to question whether or not such modern sedentary activities induce energy consumption modification in youth. The aim of this work is to compare the impact of a passive video games vs. active video games vs. physical exercise in terms of subsequent energy intake and appetite feelings in normal weight and obese youth.
Read the detailed description
After a medical inclusion, the adolescents will have to realise a DXA to assess their body composition and a submaximal exercise to evaluate their aerobic capacities.
They will have then to enter the laboratory on three different occasions in a randomized order from 8am to 730pm: At 8am they will receive a calibrated breakfast. then, at 1045; they will have to complete one of the experimental condition: 1) one hour of passive video game; 2) one hour of active video game; 3) a cycling exercise. at 1215 and 0630pm, they will be offered ad libitum meals. At regular intervals through the day, their appetite feelings will be assessed using Visual analogue scales.
Energy expenditure will be assessed thanks to cardiofrequencemeters during the 1h PVG and and by indirect calomitery (K4b2) during the active video game.
Ad libitum energy consumption will be assessed by investigators and recorded for each participants.
- Being tested
- experimental condition: Passvice Video game; Avtive Video game; Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimental condition: Passvice Video game; Avtive Video game; ExerciseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Lean adolescents | Experimental | Not described Receives: Behavioral: experimental condition: Passvice Video game; Avtive Video game; Exercise |
| Obese adolescents | Experimental | Not described Receives: Behavioral: experimental condition: Passvice Video game; Avtive Video game; Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
ad libitum energy intake in kcal during the different experimental sessions: AVG, PVG and EX
At lunch and iner time on AVG, PVG and EX (the 3 experimental sessions), an ad libitum buffet meal will be oofered to the participants and their energy consumption will be weighted and registered by the investigators.
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2013
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Passive Video Games (PVG)Studies 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
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Blaise Pascal, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, THIVEL David, Université Blaise Pascal, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01912300
- Sponsor's protocol ID
- AU1033
- Status last verified
- Jul 2013
- First submitted
- 10 Jul 2013
- Last updated
- 31 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Adaptation to Contemporary Sedentary Behaviors and Physical Exercise in Youth: Effect of Weight Status
- ClinicalTrials.gov ID
- NCT01912300
- Acronym / sponsor ID
- AU1033
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Université Blaise Pascal, Clermont-FerrandUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2014 (estimated)
- First posted
- 31 Jul 2013 (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.
Sedentary behaviors have been shown to increase food consumption among youth and adults. The recent active video games devices have been suggested to compensate for the increased energy intake they induce by the increased energy expenditure they generate. To date no study has been conducted to question whether or not such modern sedentary activities induce energy consumption modification in youth. The aim of this work is to compare the impact of a passive video games vs. active video games vs. physical exercise in terms of subsequent energy intake and appetite feelings in normal weight and obese youth.
Detailed description
After a medical inclusion, the adolescents will have to realise a DXA to assess their body composition and a submaximal exercise to evaluate their aerobic capacities.
They will have then to enter the laboratory on three different occasions in a randomized order from 8am to 730pm: At 8am they will receive a calibrated breakfast. then, at 1045; they will have to complete one of the experimental condition: 1) one hour of passive video game; 2) one hour of active video game; 3) a cycling exercise. at 1215 and 0630pm, they will be offered ad libitum meals. At regular intervals through the day, their appetite feelings will be assessed using Visual analogue scales.
Energy expenditure will be assessed thanks to cardiofrequencemeters during the 1h PVG and and by indirect calomitery (K4b2) during the active video game.
Ad libitum energy consumption will be assessed by investigators and recorded for each participants.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lean adolescents | Experimental | Behavioral: experimental condition: Passvice Video game; Avtive Video game; Exercise |
| Obese adolescents | Experimental | Behavioral: experimental condition: Passvice Video game; Avtive Video game; Exercise |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- male
- 12-15 years old
- BMI defining obesity (Cole et al., 2000)
- Not being under diet restriction
- Information and consent forms have to be signed by the adolescent and his legal representative
Key exclusion criteria (4 listed)
- Being under medication
- contraindication to exercise
- smokers
- dieting
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 |
|---|---|---|
| experimental condition: Passvice Video game; Avtive Video game; Exercise | Behavioural | Lean adolescents, Obese adolescents |
Primary outcome
ad libitum energy intake in kcal during the different experimental sessions: AVG, PVG and EX
Time frame: up to 2 months
At lunch and iner time on AVG, PVG and EX (the 3 experimental sessions), an ad libitum buffet meal will be oofered to the participants and their energy consumption will be weighted and registered by the investigators.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2013.
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 experimental condition: Passvice Video game; Avtive Video game; Exercise in people with Passive Video Games (PVG) and Active Video Games (AVG), run by Université Blaise Pascal, Clermont-Ferrand at 1 site in France.
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 6 inclusion and 4 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: withdrawn, as of the sponsor's last update on 31 Jul 2013. 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 France. 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 was withdrawn before enrolling participants, so there are no results.
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?
ad libitum energy intake in kcal during the different experimental sessions: AVG, PVG and EX (time frame: up to 2 months). 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 31 Jul 2013.