Appetitive BehaviorNCT03722251
Active Video-game Playing and Food Intake in Children
A study of Appetitive Behavior, run by Toronto Metropolitan University at 1 site in Canada.
Trial summary
The purpose of this experiment is to investigate the effect of active video game playing for 30 minutes on food intake and subjective appetite. The investigators hypothesize that video game playing will affect food intake in children. Read more about this study
- Who is it for?
- Ages 9 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetitive Behavior
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteCanada
- Study dates
- 6 Apr 2012to 25 May 2015
- 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 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy boys with no emotional, behavioral or learning problems
Who cannot join
- Exclusion criteria are children with significant behavioral or emotional difficulties, those with dietary restrictions, or those taking medications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Active Video-game Playing and a Glucose Preload on Food Intake Regulation in Children
The purpose of this experiment is to investigate the effect of active video game playing for 30 minutes on food intake and subjective appetite. The investigators hypothesize that video game playing will affect food intake in children. Food intake will be measured at 30 minutes following a glucose (50g glucose in 250ml of water) or sweetened non-caloric (150mg Sucralose® in 250ml of water) beverage with or without active video game playing. Subjective appetite will be measured at 0, 15, 30 and 60 minutes.
- Conditions
- Appetitive Behavior
- Being tested
- Glucose beverage, control beverage, glucose beverage and active video game playing, control beverage and active video game playing
- Keywords
- appetite, food intake, active gaming
- Medical subject headings
- Appetitive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose beverage, control beverage, glucose beverage and active video game playing, control beverage and active video game playingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Glucose Beverage | Experimental | 50 g of glucose in solution Receives: Behavioral: Glucose beverage, control beverage, glucose beverage and active video game playing, control beverage and active video game playing |
| Control Beverage | Experimental | Sucralose in solution Receives: Behavioral: Glucose beverage, control beverage, glucose beverage and active video game playing, control beverage and active video game playing |
| Glucose beverage and active video game playing | Experimental | 50 g of glucose in solution and 30 min of active video game playing Receives: Behavioral: Glucose beverage, control beverage, glucose beverage and active video game playing, control beverage and active video game playing |
| Control Beverage and active video game playing | Experimental | Sucralose in solution and 30 min of active video game playing Receives: Behavioral: Glucose beverage, control beverage, glucose beverage and active video game playing, control beverage and active video game playing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food Intake (kcal)
Measured: 30 minutes after treatment
Subjective appetite (mm)
subjective appetite assessed by motivation-to-eat visual analogue scale. The scale range is between 0 and 100 mm. Higher scores represent higher appetite
Measured: baseline and then 15, 30, and 60 minutes after preload consumption
Secondary outcomes (1)
Subjective Mood (mm)
Measured using visual analogue scale (mm). Each VAS is a 100 mm line where they will place a pencil mark to describe their feelings.
Measured: baseline and then 15, 30, and 60 minutes after preload consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start6 Apr 2012
- Primary completion25 May 2015
- Study completion25 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appetitive BehaviorStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Repeated measures cross-over design.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toronto Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nick Bellissimo, Toronto Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03722251
- Sponsor's protocol ID
- REB: 2012-120-1
- Status last verified
- Oct 2018
- First submitted
- 25 Oct 2018
- Last updated
- 29 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- Individual data sharing
- Undecided: Data will be shared upon request.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Video-game Playing and a Glucose Preload on Food Intake Regulation in Children
- ClinicalTrials.gov ID
- NCT03722251
- Acronym / sponsor ID
- REB: 2012-120-1
- Conditions
- Appetitive Behavior
- Keywords
- appetite, food intake, active gaming
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Toronto Metropolitan UniversityUniversity, hospital or other
- Study start
- 6 Apr 2012 (actual)
- Primary completion
- 25 May 2015 (actual)
- Study completion
- 25 May 2015 (actual)
- First posted
- 26 Oct 2018 (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.
The purpose of this experiment is to investigate the effect of active video game playing for 30 minutes on food intake and subjective appetite. The investigators hypothesize that video game playing will affect food intake in children. Food intake will be measured at 30 minutes following a glucose (50g glucose in 250ml of water) or sweetened non-caloric (150mg Sucralose® in 250ml of water) beverage with or without active video game playing. Subjective appetite will be measured at 0, 15, 30 and 60 minutes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Repeated measures cross-over design.
| Arm | Type | Receives |
|---|---|---|
| Glucose Beverage | Experimental | Behavioral: Glucose beverage, control beverage, glucose beverage and active video game playing, control beverage and active video game playing50 g of glucose in solution |
| Control Beverage | Experimental | Behavioral: Glucose beverage, control beverage, glucose beverage and active video game playing, control beverage and active video game playingSucralose in solution |
| Glucose beverage and active video game playing | Experimental | Behavioral: Glucose beverage, control beverage, glucose beverage and active video game playing, control beverage and active video game playing50 g of glucose in solution and 30 min of active video game playing |
| Control Beverage and active video game playing | Experimental | Behavioral: Glucose beverage, control beverage, glucose beverage and active video game playing, control beverage and active video game playingSucralose in solution and 30 min of active video game playing |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- healthy boys with no emotional, behavioral or learning problems
Key exclusion criteria (1 listed)
- Exclusion criteria are children with significant behavioral or emotional difficulties, those with dietary restrictions, or those taking medications.
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 |
|---|---|---|
| Glucose beverage, control beverage, glucose beverage and active video game playing, control beverage and active video game playing | Behavioural | Control Beverage, Control Beverage and active video game playing, Glucose Beverage, Glucose beverage and active video game playing |
Primary outcome
Food Intake (kcal)
Time frame: 30 minutes after treatment
Subjective appetite (mm)
Time frame: baseline and then 15, 30, and 60 minutes after preload consumption
subjective appetite assessed by motivation-to-eat visual analogue scale. The scale range is between 0 and 100 mm. Higher scores represent higher appetite
1 secondary outcome
Subjective Mood (mm)
Time frame: baseline and then 15, 30, and 60 minutes after preload consumption
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 29 Oct 2018.
- Individual participant dataSharing planned: Undecided. Data will be shared upon request.
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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.
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 of Appetitive Behavior, run by Toronto Metropolitan University at 1 site in Canada.
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 29 Oct 2018. 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 Canada. 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?
Food Intake (kcal) (time frame: 30 minutes after treatment). The study lists 2 primary outcomes in all. 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 29 Oct 2018.