Appetite and General Nutritional DisordersNCT02075827
Metabolic Response to Playing Video Games: Two Arm Trial
A study testing Competitive video game and Little Big Planet in people with Appetite and General Nutritional Disorders and Sedentary Lifestyle, run by University College, London at 1 site in United Kingdom.
Trial summary
Previous studies have shown that subjects who play video games are prone to consume larger quantities of food than subjects who are simply resting. This is believed to be due to the development of a stress response in the video games group, resulting in increased fuel metabolism. 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
- Appetite and General Nutritional Disorders, Sedentary Lifestyle
- What is being tested?
- Competitive video game and Little Big Planet
- 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 2014to Oct 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 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult males with BMI <25 kg/m2
Who cannot join
- smoking
- a significant weight change (>3kg) within the previous three months
- any psychiatric disorder
- uncontrolled hypertension
- coronary heart disease
- heart failure
- central/peripheral arteriopathies
- excessive 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
Panos Michael, +44(0)7546842700, panos.michael.11@ucl.ac.uk
Jonathan CK Wells, PhD
About this study
Previous studies have shown that subjects who play video games are prone to consume larger quantities of food than subjects who are simply resting. This is believed to be due to the development of a stress response in the video games group, resulting in increased fuel metabolism. However, it was shown that the energy intake of the two groups showed no correlation with the subjects' appetite/hunger, which was identical in both groups.
The investigators propose to explore this issue further by comparing the effects of different types of video games on metabolism, using a randomized controlled trial. In this study, they will compare the stress levels, heart rate, blood pressure, appetite/mood, energy consumption, grip strength, memory and saliva cortisol, leptin and ghrelin levels of subjects playing (a) competitive and (b) problem-solving video games. Measurements will be taken preceding, during and after the 1 hour intervention. Following the intervention, participants will be offered savoury and sweet foods/drinks, which will allow us to assess their appetite preferences and caloric intake.
The investigators first aim is to determine whether there is a significant difference in stress levels, eating habits and energy metabolism in the two groups. Our second aim is to determine whether there is a difference in glucose distribution to the muscles and brain between the two groups.
Read the detailed description
The investigators study is designed to test experimentally whether different kinds of video game generate different types of metabolic response. The exposure comprises one-hour of video game playing, with 36 young men randomized to each group (ie 72 in total).
Prior to the exposure, they will collect baseline data on heart rate, blood pressure, anthropometry (weight, height, waist girth), grip strength and cognitive function (memory test), as well as appetite/mood by visual analogue scale (VAS). The investigators will also collect a baseline saliva sample to assess hormones associated with stress (cortisol) or satiety (leptin, ghrelin). The subject will arrive after and overnight fast and will be given a standardised breakfast. After these baseline data are collected, the randomization envelope will be opened and the subject assigned to his group.
Heart rate will be monitored continuously during the study. At 20 and 40 minutes during the intervention, as well as when it ceases at 60 minutes, the investigators will collect further data on blood pressure and appetite/mood by VAS. At 60 minutes, the investigators will repeat measurement of memory and grip strength, and collect a second saliva sample.
For 20 minutes after the end of the intervention, the subject will be allowed to rest, reading magazines, and will be able to select from a range of snack foods (savoury, sweet, fruit), and drinks (sweetened beverages, water). Consumption of calories will be calculated. At the end of this period, final measurements of blood pressure and VAS will be collected, and the subject will depart.
- Being tested
- Competitive video game, Little Big Planet
- Keywords
- Appetite, metabolism, sedentary behaviour, stress response
- Medical subject headings
- Sedentary Behavior, Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Competitive video gameBehavioural
Also called 'Call of Duty' (Activision)
1 hour playing video game
Little Big PlanetBehavioural
Also called Little Big Planet (Sony Computer Entertainment
1 hour playing video game
| Study group | Role | What they receive |
|---|---|---|
| Problem-solving video game | Active comparator | Playing the video game 'Little Big Planet' Receives: Behavioral: Little Big Planet |
| Competitive video game | Experimental | Playing the video game 'Call of Duty' Receives: Behavioral: Competitive video game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food intake
Subjects will be offered a selection of snacks and drinks over a 20 minute period, and their rates of food intake will be calculated
Measured: At end of 1-hour video game intervention
Secondary outcomes (8)
Blood pressure
Blood pressure will be measured in duplicate at 1 minute intervals by digital instrument
Measured: At 20, 40 and 60 minutes of intervention, and after 20 minutes rest post-intervention
Heart rate
Heart rate will be measured using a polar digital heart rate monitor
Measured: Continuously, starting during baseline period, from 0 to 60 minutes during intervention, and for 20 minutes post-intervention rest period
Salivary leptin
Salivary leptin will be analysed using ELISA
Measured: After 60 minutes from start of intervention
Salivary ghrelin
Salivary ghrelin will be assessed using ELISA
Measured: After 60 minutes from start of intervention
Salivary cortisol
Salivary cortisol will be assessed using ELISA
Measured: After 60 minutes from start of intervention
Visual analogue scale
Visual analogue scale will be used to collect subjective data on mood and appetite
Measured: At 20, 40 and 60 minutes of intervention, and after 20 minutes rest post-intervention
Grip strength
Grip strength will be assessed by hand-grip dynamometer, using the average of three measurements for each arm
Measured: After 60 minutes from start of intervention
Memory recall
Subjects will be shown images for a set time to allow memorization, and then be given another set time to recall as many of these images as possible
Measured: After 60 minutes from start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Appetite and General Nutritional DisordersStudies 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
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan CK Wells, PhD, Principal investigator, UCL Institute of Child Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02075827
- Sponsor's protocol ID
- UCL0326011
- Status last verified
- Feb 2014
- First submitted
- 24 Feb 2014
- Last updated
- 3 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Siervo M, Sabatini S, Fewtrell MS, Wells JC. Acute effects of violent video-game playing on blood pressure and appetite perception in normal-weight young men: a randomized controlled trial. Eur J Clin Nutr. 2013 Dec;67(12):1322-4. doi: 10.1038/ejcn.2013.180. Epub 2013 Oct 2.
PubMed 24084510
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Response to Playing Video Games: Two Arm Trial
- ClinicalTrials.gov ID
- NCT02075827
- Acronym / sponsor ID
- UCL0326011
- Keywords
- Appetite, metabolism, sedentary behaviour, stress response
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Oct 2014 (estimated)
- First posted
- 3 Mar 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.
Previous studies have shown that subjects who play video games are prone to consume larger quantities of food than subjects who are simply resting. This is believed to be due to the development of a stress response in the video games group, resulting in increased fuel metabolism. However, it was shown that the energy intake of the two groups showed no correlation with the subjects' appetite/hunger, which was identical in both groups.
The investigators propose to explore this issue further by comparing the effects of different types of video games on metabolism, using a randomized controlled trial. In this study, they will compare the stress levels, heart rate, blood pressure, appetite/mood, energy consumption, grip strength, memory and saliva cortisol, leptin and ghrelin levels of subjects playing (a) competitive and (b) problem-solving video games. Measurements will be taken preceding, during and after the 1 hour intervention. Following the intervention, participants will be offered savoury and sweet foods/drinks, which will allow us to assess their appetite preferences and caloric intake.
The investigators first aim is to determine whether there is a significant difference in stress levels, eating habits and energy metabolism in the two groups. Our second aim is to determine whether there is a difference in glucose distribution to the muscles and brain between the two groups.
Detailed description
The investigators study is designed to test experimentally whether different kinds of video game generate different types of metabolic response. The exposure comprises one-hour of video game playing, with 36 young men randomized to each group (ie 72 in total).
Prior to the exposure, they will collect baseline data on heart rate, blood pressure, anthropometry (weight, height, waist girth), grip strength and cognitive function (memory test), as well as appetite/mood by visual analogue scale (VAS). The investigators will also collect a baseline saliva sample to assess hormones associated with stress (cortisol) or satiety (leptin, ghrelin). The subject will arrive after and overnight fast and will be given a standardised breakfast. After these baseline data are collected, the randomization envelope will be opened and the subject assigned to his group.
Heart rate will be monitored continuously during the study. At 20 and 40 minutes during the intervention, as well as when it ceases at 60 minutes, the investigators will collect further data on blood pressure and appetite/mood by VAS. At 60 minutes, the investigators will repeat measurement of memory and grip strength, and collect a second saliva sample.
For 20 minutes after the end of the intervention, the subject will be allowed to rest, reading magazines, and will be able to select from a range of snack foods (savoury, sweet, fruit), and drinks (sweetened beverages, water). Consumption of calories will be calculated. At the end of this period, final measurements of blood pressure and VAS will be collected, and the subject will depart.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Problem-solving video game | Active comparator | Behavioral: Little Big PlanetPlaying the video game 'Little Big Planet' |
| Competitive video game | Experimental | Behavioral: Competitive video gamePlaying the video game 'Call of Duty' |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy adult males with BMI <25 kg/m2
Key exclusion criteria (8 listed)
- smoking
- a significant weight change (>3kg) within the previous three months
- any psychiatric disorder
- uncontrolled hypertension
- coronary heart 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 |
|---|---|---|
| Competitive video gameAlso: 'Call of Duty' (Activision)1 hour playing video game | Behavioural | Competitive video game |
| Little Big PlanetAlso: Little Big Planet (Sony Computer Entertainment1 hour playing video game | Behavioural | Problem-solving video game |
Primary outcome
Food intake
Time frame: At end of 1-hour video game intervention
Subjects will be offered a selection of snacks and drinks over a 20 minute period, and their rates of food intake will be calculated
8 secondary outcomes
Blood pressure
Time frame: At 20, 40 and 60 minutes of intervention, and after 20 minutes rest post-intervention
Heart rate
Time frame: Continuously, starting during baseline period, from 0 to 60 minutes during intervention, and for 20 minutes post-intervention rest period
Salivary leptin
Time frame: After 60 minutes from start of intervention
Salivary ghrelin
Time frame: After 60 minutes from start of intervention
Salivary cortisol
Time frame: After 60 minutes from start of intervention
Visual analogue scale
Time frame: At 20, 40 and 60 minutes of intervention, and after 20 minutes rest post-intervention
Grip strength
Time frame: After 60 minutes from start of intervention
Memory recall
Time frame: After 60 minutes from start of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2014.
- Background: PubMed 24084510Siervo M, Sabatini S, Fewtrell MS, Wells JC. Acute effects of violent video-game playing on blood pressure and appetite perception in normal-weight young men: a randomized controlled trial. Eur J Clin Nutr. 2013 Dec;67(12):1322-4. doi: 10.1038/ejcn.2013.180. Epub 2013 Oct 2.
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 CK 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 Competitive video game and Little Big Planet in people with Appetite and General Nutritional Disorders and Sedentary Lifestyle, 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 8 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 3 Mar 2014. 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 Panos Michael (+44(0)7546842700, panos.michael.11@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food intake (time frame: At end of 1-hour video game intervention). 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 NCT02075827, which also lists 1 linked publication.
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 3 Mar 2014.