Blood PressureNCT01809470
Metabolic Response to Playing Video Games
A study testing FIFA2013, Call of Duty and Watching TV in people with Blood Pressure, run by University College, London at 1 site in United Kingdom.
Trial summary
The study is investigating the metabolic response to playing competitive non-violent and competitive violent video games. The primary hypothesis is that the metabolic response in the violent game group will differ from the other two groups, due to activation of the stress response. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- FIFA2013, Call of Duty and Watching TV
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2013to Dec 2013
- 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 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI >25 kg/m2
Who cannot join
- smoker
- weight change >3 kg in the previous three months
- psychiatric disorder
- uncontrolled hypertension
- coronary heart disease, heart failure and central or peripheral arteriopathies
- alcohol consumption > 21 units/week.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
UCL Institute of Child Health
London, WC1N 1EH
Jonathan C Wells, PhD, +442079052389, Jonathan.Wells@ucl.ac.uk
Jonathan C Wells, PhD
About this study
The study is investigating the metabolic response to playing competitive non-violent and competitive violent video games. The primary hypothesis is that the metabolic response in the violent game group will differ from the other two groups, due to activation of the stress response. The investigators are using an experimental approach, whereby 72 young men are randomised to one of three groups: watching television (TV), playing the non-violent video game 'FIFA2013', or playing the violent video game 'Call of Duty'. Participants arrive fasted, and are given a standardised breakfast. After measurements of weight, height and waist girth, they then are assigned to one of the three groups. Baseline blood pressure, heart rate and appetite/mood data are collected, along with a saliva sample for measurement of the 'stress' hormone, cortisol. The investigators will collect these data again at 4 time-points during the one hour game-playing session. At the end of the study, the allow the participants half an hour of rest, during which they can choose from a variety of sweet or savoury snacks. The investigators will compare the data from the three groups, to test whether changes in blood pressure, heart rate and salivary cortisol, as well as snack consumption, are greater in the group playing the violent game.
Read the detailed description
Our study is investigating the metabolic response to playing competitive non-violent and competitive violent video games. Our primary hypothesis is that the metabolic response in the violent game group will differ from the other two groups, due to activation of the stress response.
We are using an experimental approach, whereby 72 young men are randomised to one of three groups: watching TV, playing the non-violent video game 'FIFA2013', or playing the violent video game 'Call of Duty'. All participants must already have some experience playing the two games, so that whichever group they are assigned to, they can comply with the protocol.
Participants arrive after an overnight fast, and are given a standardised breakfast (a muffin, approx 300 kcal, and a glass of water). After measurements of weight, height and waist girth, they then are assigned to one of the three groups, and allowed to familiarise themselves with the games console or TV. Baseline data on blood pressure (in triplicate, Accutor digital monitor), heart rate (Polar monitor) and appetite/mood (visual analogue scale) are collected, along with a saliva sample for measurement of the 'stress' hormone, cortisol, as well as satiety hormones sich as leptin and ghrelin. We will collect these data again at 4 time-points during the one hour game-playing session, by pausing the game or TV for 4 minutes at 15, 30, 45 and 60 minutes after the session starts.
At the end of the study, we allow the participants half an hour of rest, during which they can choose from a variety of sweet or savoury snacks or fruit, and several drinks.
We will compare the data from the three groups, to test whether changes in blood pressure, heart rate, appetite/mood and salivary hormones, as well as snack consumption, are greater in the group playing the violent game.
- Conditions
- Blood Pressure
- Being tested
- FIFA2013, Call of Duty, Watching TV
- Keywords
- Blood pressure, Appetite, Heart rate, Salivary cortisol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FIFA2013Behavioural
Playing FIFA2013 for 1 hour
Call of DutyBehavioural
Playing Call of Duty for 1 hour
Watching TVBehavioural
Watching TV for 1 hour
| Study group | Role | What they receive |
|---|---|---|
| Watching TV | Experimental | Watching TV (comedy, 'Friends') for 1 hour Receives: Behavioral: Watching TV |
| FIFA2013 | Experimental | Playing the video game 'FIFA2013' for 1 hour Receives: Behavioral: FIFA2013 |
| Call of Duty | Experimental | Playing the video game 'Call of duty' for 1 hour Receives: Behavioral: Call of Duty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Systolic and diastolic blood pressure
Measured: Over the 90 minutes of the study
Secondary outcomes (4)
Heart rate
Heart rate by Polar monitor
Measured: Over the 90 minute duration of the study
Appetite
Appetite by visual analogue scale, and by a test meal at the end of the study
Measured: Over the 90 minute duration of the study
Stress
Salivary cortisol
Measured: Over the 90 minute duration of the study
Satiety
Salivary ghrelin and leptin
Measured: Over the 90 minute duration of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Newcastle University
- Responsible party
- Sponsor
- Investigators
- Jonathan C Wells, PhD, Principal investigator, UCL Institute of Child Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01809470
- Sponsor's protocol ID
- UCL-VG-001
- Status last verified
- Jan 2013
- First submitted
- 8 Mar 2013
- Last updated
- 9 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Response to Playing Video Games
- ClinicalTrials.gov ID
- NCT01809470
- Acronym / sponsor ID
- UCL-VG-001
- Conditions
- Blood Pressure
- Keywords
- Blood pressure, Appetite, Heart rate, Salivary cortisol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Newcastle University
- Study start
- Feb 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 12 Mar 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.
The study is investigating the metabolic response to playing competitive non-violent and competitive violent video games. The primary hypothesis is that the metabolic response in the violent game group will differ from the other two groups, due to activation of the stress response. The investigators are using an experimental approach, whereby 72 young men are randomised to one of three groups: watching television (TV), playing the non-violent video game 'FIFA2013', or playing the violent video game 'Call of Duty'. Participants arrive fasted, and are given a standardised breakfast. After measurements of weight, height and waist girth, they then are assigned to one of the three groups. Baseline blood pressure, heart rate and appetite/mood data are collected, along with a saliva sample for measurement of the 'stress' hormone, cortisol. The investigators will collect these data again at 4 time-points during the one hour game-playing session. At the end of the study, the allow the participants half an hour of rest, during which they can choose from a variety of sweet or savoury snacks. The investigators will compare the data from the three groups, to test whether changes in blood pressure, heart rate and salivary cortisol, as well as snack consumption, are greater in the group playing the violent game.
Detailed description
Our study is investigating the metabolic response to playing competitive non-violent and competitive violent video games. Our primary hypothesis is that the metabolic response in the violent game group will differ from the other two groups, due to activation of the stress response.
We are using an experimental approach, whereby 72 young men are randomised to one of three groups: watching TV, playing the non-violent video game 'FIFA2013', or playing the violent video game 'Call of Duty'. All participants must already have some experience playing the two games, so that whichever group they are assigned to, they can comply with the protocol.
Participants arrive after an overnight fast, and are given a standardised breakfast (a muffin, approx 300 kcal, and a glass of water). After measurements of weight, height and waist girth, they then are assigned to one of the three groups, and allowed to familiarise themselves with the games console or TV. Baseline data on blood pressure (in triplicate, Accutor digital monitor), heart rate (Polar monitor) and appetite/mood (visual analogue scale) are collected, along with a saliva sample for measurement of the 'stress' hormone, cortisol, as well as satiety hormones sich as leptin and ghrelin. We will collect these data again at 4 time-points during the one hour game-playing session, by pausing the game or TV for 4 minutes at 15, 30, 45 and 60 minutes after the session starts.
At the end of the study, we allow the participants half an hour of rest, during which they can choose from a variety of sweet or savoury snacks or fruit, and several drinks.
We will compare the data from the three groups, to test whether changes in blood pressure, heart rate, appetite/mood and salivary hormones, as well as snack consumption, are greater in the group playing the violent game.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Watching TV | Experimental | Behavioral: Watching TVWatching TV (comedy, 'Friends') for 1 hour |
| FIFA2013 | Experimental | Behavioral: FIFA2013Playing the video game 'FIFA2013' for 1 hour |
| Call of Duty | Experimental | Behavioral: Call of DutyPlaying the video game 'Call of duty' for 1 hour |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI >25 kg/m2
Key exclusion criteria (6 listed)
- smoker
- weight change >3 kg in the previous three months
- psychiatric disorder
- uncontrolled hypertension
- coronary heart disease, heart failure and central or peripheral arteriopathies
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 |
|---|---|---|
| FIFA2013Playing FIFA2013 for 1 hour | Behavioural | FIFA2013 |
| Call of DutyPlaying Call of Duty for 1 hour | Behavioural | Call of Duty |
| Watching TVWatching TV for 1 hour | Behavioural | Watching TV |
Primary outcome
Blood pressure
Time frame: Over the 90 minutes of the study
Systolic and diastolic blood pressure
4 secondary outcomes
Heart rate
Time frame: Over the 90 minute duration of the study
Appetite
Time frame: Over the 90 minute duration of the study
Stress
Time frame: Over the 90 minute duration of the study
Satiety
Time frame: Over the 90 minute duration of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2013.
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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.
Jonathan C Wells, PhD principal investigator
UCL Institute of Child Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FIFA2013, Call of Duty and Watching TV in people with Blood Pressure, run by University College, London at 1 site in United Kingdom.
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 6 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: status not confirmed, as of the sponsor's last update on 9 Apr 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathan C Wells, PhD (+442079052389, Jonathan.Wells@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: Over the 90 minutes of the study). 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 9 Apr 2013.