NCT01809470

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 8, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 12, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 9, 2013

Status Verified

January 1, 2013

Enrollment Period

10 months

First QC Date

March 8, 2013

Last Update Submit

April 8, 2013

Conditions

Keywords

Blood pressureAppetiteHeart rateSalivary cortisol

Outcome Measures

Primary Outcomes (1)

  • Blood pressure

    Systolic and diastolic blood pressure

    Over the 90 minutes of the study

Secondary Outcomes (4)

  • Heart rate

    Over the 90 minute duration of the study

  • Appetite

    Over the 90 minute duration of the study

  • Stress

    Over the 90 minute duration of the study

  • Satiety

    Over the 90 minute duration of the study

Study Arms (3)

Watching TV

EXPERIMENTAL

Watching TV (comedy, 'Friends') for 1 hour

Behavioral: Watching TV

FIFA2013

EXPERIMENTAL

Playing the video game 'FIFA2013' for 1 hour

Behavioral: FIFA2013

Call of Duty

EXPERIMENTAL

Playing the video game 'Call of duty' for 1 hour

Behavioral: Call of Duty

Interventions

FIFA2013BEHAVIORAL

Playing FIFA2013 for 1 hour

FIFA2013
Call of DutyBEHAVIORAL

Playing Call of Duty for 1 hour

Call of Duty
Watching TVBEHAVIORAL

Watching TV for 1 hour

Watching TV

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI \>25 kg/m2

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCL Institute of Child Health

London, WC1N 1EH, United Kingdom

RECRUITING

Study Officials

  • Jonathan C Wells, PhD

    UCL Institute of Child Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan C Wells, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2013

First Posted

March 12, 2013

Study Start

February 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

April 9, 2013

Record last verified: 2013-01

Locations