Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001103853
Ethics application status
Not yet submitted
Date submitted
15/10/2012
Date registered
16/10/2012
Date last updated
20/11/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of Screen-based Sedentary Activities on Energy Intake (ESSAY)
Scientific title
Comparative effects of television, computer games, and video games on acute energy intake in boys aged 9-12 years: a randomised crossover trial
Secondary ID [1] 281392 0
Nil known
Universal Trial Number (UTN)
U1111­1134­8139
Trial acronym
ESSAY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight and obesity 287628 0
Condition category
Condition code
Public Health 287958 287958 0 0
Other public health
Diet and Nutrition 287972 287972 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will be exposed to three 1-h conditions in random order: watching television, sedentary video game play, and computer game play. Television is considered the exposure condition. During each condition the subject will have access to a variety or food and drink. Each subject will undergo a 1-week washout period between conditions.
Intervention code [1] 285870 0
Lifestyle
Intervention code [2] 285884 0
Behaviour
Comparator / control treatment
Subjects will be exposed to three 1-h conditions in random order: watching television, sedentary video game play, and computer game play. Sedentary video game play and computer game play are considered the active control conditions. During each condition the subject will have access to a variety or food and drink. Each subject will undergo a 1-week washout period between conditions.
Control group
Active

Outcomes
Primary outcome [1] 288172 0
Between-group difference in energy intake (kcal consumed) during the 1h exposure (TV versus sedentary video game, and TV versus computer game).
Energy intake will be calculated by multiplying the grams/mLs consumed by the energy density (kcal/g or kcal/mL) for the different food and drink types. Energy densities will be those provided by the food manufacturers (as stated on the labels) or from standardised nutritional values (FOODfiles).
Timepoint [1] 288172 0
1h (immediately after exposure).
Secondary outcome [1] 299541 0
Amount of food (g) consumed.
Food will be weighed before and after the exposure period, with differences in weights being the number of grams of food consumed.
Timepoint [1] 299541 0
1h (immediately after exposure).
Secondary outcome [2] 299563 0
Appetite
Appetite will be assessed using a visual analogue scale (VAS).
Timepoint [2] 299563 0
0h (before exposure) and 1h (immediately after exposure).
Secondary outcome [3] 299564 0
Hunger
Hunger will be assessed using a VAS, which ranges from 0 (I am not hungry at all) to 10 (I have never been hungrier).
Timepoint [3] 299564 0
0h (before exposure) and 1h (immediately after exposure).
Secondary outcome [4] 299565 0
Satiety
Satiety will be assessed using a VAS, which ranges from 0 (I am completely empty) to 10 (I cannot eat another bite).
Timepoint [4] 299565 0
0h (before exposure) and 1h (immediately after exposure).
Secondary outcome [5] 299566 0
Fullness.
Fullness will be assessed using a VAS, which ranges from 0 (not at all full) to 10 (totally full).
Timepoint [5] 299566 0
0h (before exposure) and 1h (immediately after exposure).
Secondary outcome [6] 299567 0
Prospective food consumption (i.e. how much do you think you can eat?)
Prospective food consumption will be assessed using a VAS, which ranges from 0 (nothing at all) to 10 (a lot).
Timepoint [6] 299567 0
0h (before exposure).
Secondary outcome [7] 299568 0
Desire to eat something sweet (i.e. would you like to eat something sweet?)
This will be assessed using a VAS, which ranges from 0 (yes, very much) to 10 (no, not at all).
Timepoint [7] 299568 0
0h (before exposure) and 1h (immediately after exposure).
Secondary outcome [8] 299569 0
Desire to eat something salty (i.e. would you like to eat something salty?)
This will be assessed using a VAS, which ranges from 0 (yes, very much) to 10 (no, not at all).
Timepoint [8] 299569 0
0h (before exposure) and 1h (immediately after exposure).
Secondary outcome [9] 299570 0
Desire to eat something fatty (i.e. would you like to eat something fatty?)
This will be assessed using a VAS, which ranges from 0 (yes, very much) to 10 (no, not at all).
Timepoint [9] 299570 0
0h (before exposure) and 1h (immediately after exposure).
Secondary outcome [10] 299571 0
Memory for food consumed.
Subjects will be asked to list the food and drinks they remember eating/drinking during the previous hour and whether they ate/drank the whole portion or not.
Timepoint [10] 299571 0
1h (immediately after exposure).

Eligibility
Key inclusion criteria
1. Aged 9-12 years
2. Healthy, normal-weight (5th percentile to less than 85th percentile) boys
3. Able to provide informed consent
4. Able to read and understand English
Minimum age
9 Years
Maximum age
12 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Unstable body weight during the previous 6 months (defined as a change in body weight of at least 4kg)
2. Inability to understand and/or comply with study protocol
3. Known food allergies

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants will be identified from the list of ineligible subjects from the SWITCH (Screen ­time Weight­loss 
Intervention Targeting Children and Home) trial. The SWITCH trial, which is currently being conducted in our department, requires participants to be overweight or obese. There is a list of boys whose caregivers/parents were interested in taking part in SWITCH but who were ineligible due to their body weight. SWITCH researchers will ask the caregivers of ineligible boys for permission for an ESSAY researcher to 
contact them. If they agree, participants will be contacted by phone by trained study personnel and the ESSAY 
study will be explained in detail. If they express interest, the child will be screened for eligibility. A baseline 
assessment appointment will be arranged with eligible participants. At the baseline 
appointment the researcher will go through the information sheets and consent forms and ensure that the 
participant and parent/caregiver understand that participation is voluntary, this will also be outlined in the Consent 
Form. Subjects will then be randomised using a central computer system. Allocation concealment will be maintained up until the point of randomisation using this method.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible subjects will be randomised by a computerised central randomisation system.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 4598 0
New Zealand
State/province [1] 4598 0

Funding & Sponsors
Funding source category [1] 286146 0
University
Name [1] 286146 0
National Institute for Health Innovation, University of Auckland
Country [1] 286146 0
New Zealand
Primary sponsor type
Individual
Name
Samantha Marsh
Address
National Institute for Health Innovation
University of Auckland
Private Bag 92019, Auckland Mailing Centre
Auckland, 1142
Country
New Zealand
Secondary sponsor category [1] 284955 0
None
Name [1] 284955 0
Address [1] 284955 0
Country [1] 284955 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288202 0
Health and Disability Ethics Committee
Ethics committee address [1] 288202 0
Ethics committee country [1] 288202 0
New Zealand
Date submitted for ethics approval [1] 288202 0
19/09/2012
Approval date [1] 288202 0
Ethics approval number [1] 288202 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34828 0
Address 34828 0
Country 34828 0
Phone 34828 0
Fax 34828 0
Email 34828 0
Contact person for public queries
Name 18075 0
Samantha Marsh
Address 18075 0
National Institute for Health Innovation
University of Auckland
Private Bag 92019, Auckland Mailing Centre
Auckland, 1142
Country 18075 0
New Zealand
Phone 18075 0
+64 9 3737 599 ext 88061
Fax 18075 0
Email 18075 0
[email protected]
Contact person for scientific queries
Name 9003 0
Ralph Maddison
Address 9003 0
National Institute for Health Innovation
University of Auckland
Private Bag 92019, Auckland Mailing Centre
Auckland, 1142
Country 9003 0
New Zealand
Phone 9003 0
+64 9 3737 599 ext 84767
Fax 9003 0
Email 9003 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.