Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001287729
Ethics application status
Approved
Date submitted
20/11/2013
Date registered
21/11/2013
Date last updated
23/10/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
SCReen use - Effects on Energy iNtake (SCREEN): Comparison of two different screen-use behaviours (Single screen [TV Watching] versus Multi-screen [TV + Smartphone + iPad]) on energy intake in normal-weight males aged 14 - 18 years of age.
Scientific title
Comparison of two different screen-use behaviours (single screen [TV watching] versus multi-screen [TV + Smartphone + iPad]) on energy intake in normal-weight males aged 14-18 years of age.
Secondary ID [1] 283622 0
Nil
Universal Trial Number (UTN)
U1111-1150-6020
Trial acronym
SCREEN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight/Obesity 290550 0
Sedentary behaviour 290551 0
Condition category
Condition code
Public Health 290949 290949 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will undergo a 1-hour multi-screen exposure, during which they will watch TV while having access to a smartphone and an iPad computer. During the 1-hour exposure, participants will also have access to a variety of food (e.g. chocolate, yoghurt, and fruit) and drink (water and soda). The study will take place in a laboratory room situated at the University of Auckland, Tamaki campus. The participant will be alone in the laboratory room (i.e. there will not be any other participants in the room with them).
Intervention code [1] 288316 0
Behaviour
Comparator / control treatment
Participants will undergo a 1-hour single-screen exposure, during which they will watch TV. During the 1-hour exposure, participants will also have access to a variety of food (e.g. chocolate, yoghurt, and fruit) and drink (water and soda). The study will take place in a laboratory room situated at the University of Auckland, Tamaki campus. The participant will be alone in the laboratory room (i.e. there will not be any other participants in the room with them).
Control group
Active

Outcomes
Primary outcome [1] 290930 0
Energy intake (kcal consumed) during the 1h exposure.
Energy intake will be calculated by multiplying the grams consumed by the energy density (kcal/g) for the different food and drink types. Energy densities will be those provided by the food manufacturers (as stated on the labels of snack food) or from standardised food composition tables (FOODfiles).
Timepoint [1] 290930 0
At 1 hour from start of single screen or multi-screen exposure.
Secondary outcome [1] 305617 0
Amount of food (g) and drink (mL) consumed during 1 h exposure.
Food will be weighed before and after the exposure period, with differences in weights being the number of grams of food consumed.
Drink volume will be measured before and after the exposure period, with differences in volumes being the number of mLs of drink consumed.
Timepoint [1] 305617 0
At 1 hour from start of single screen or multi-screen exposure.
Secondary outcome [2] 305618 0
Post-exposure measures of appetite, hunger, satiety, and fullness. Assessed using a 100-mm Visual Analogue Scale (VAS).
Timepoint [2] 305618 0
At 1 hour from start of single screen or multi-screen exposure.

Eligibility
Key inclusion criteria
1. Males aged 14-18 years
2. Normal-weight (5th percentile to less than 85th percentile)
3. Able to provide informed consent
4. Able to read and understand English
5. Owner and user of a Smartphone
6. Familiar with using an iPad

Primary caregiver inclusion criteria (for participants aged <16 years):
1. Primary caregiver over the age of 18 years
2. Able to provide written consent to participate in study
3. Speaks and understands English
Minimum age
14 Years
Maximum age
18 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 bodyweight of at least 4kg)
2. Inability to understand and/or comply with study protocol
3. Known food allergies
4. Significant health conditions

Primary caregiver inclusion criteria:
None

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After eligibility has been confirmed, and signed informed consent obtained, participants will be randomised to intervention groups. The allocation sequence will be concealed until the point of randomisation. Allocation will be concealed using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised to intervention groups using a computer-generated randomisation list.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We intend to recruit 78 participants. A total of 78 participants will provide 80% power at the 5% level of significance (two-sided) to detect a difference of 150 kcal between conditions, assuming a standard deviation of 234 kcal. We have based this on existing studies comparing TV watching with rest conditions.
Statistical analyses will be performed using SAS version 9.3 (SAS Institute Inc. Cary NC). All statistical tests will be two-sided at a 5% significance level.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/11/2013
Actual
25/11/2013
Date of last participant enrolment
Anticipated
3/03/2014
Actual
4/03/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
78
Accrual to date
Final
78
Recruitment outside Australia
Country [1] 5645 0
New Zealand
State/province [1] 5645 0

Funding & Sponsors
Funding source category [1] 288303 0
University
Name [1] 288303 0
National Institute for Health Innovation, University of Auckland
Country [1] 288303 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] 287022 0
None
Name [1] 287022 0
Address [1] 287022 0
Country [1] 287022 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290198 0
The University of Auckland Human Participants Ethics Committee (UAHPEC)
Ethics committee address [1] 290198 0
UAHPEC Administrators
Research Integrity Unit
Level 10, Building 620
49 Symonds Street
Auckland, 1010
Ethics committee country [1] 290198 0
New Zealand
Date submitted for ethics approval [1] 290198 0
07/10/2013
Approval date [1] 290198 0
20/11/2013
Ethics approval number [1] 290198 0
010696

Summary
Brief summary
This prospective, randomised, 2-arm, parallel design study will investigate the effects of single-screen (SS) and multiple-screen (MS) exposures on energy intake in adolescent males. Participants will participate in one of two conditions: (1) SS exposure, which will involve watching TV for 1 hour, and (2) MS exposure, which will involve watching TV for 1 hour while having access to a smartphone and an iPad computer. During each exposure, a variety of food and drink will be available for the participant to consume, with the amount and type of food and drink consumed calculated at the end of the session. Study participants will be asked to complete a questionnaire to assess the home screen environment and attitudes towards screen-based activities. Prior to the condition and immediately after the condition the participant will rate subjective measures of appetite, hunger, satiety, and desire to eat something sweet, salty and fatty, using visual analogue scales. Energy intake for the remainder of the study day will be assessed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44438 0
Ms Samantha Marsh
Address 44438 0
National Institute for Health Innovation
University of Auckland
Private bag 92019
Auckland, 1142
Country 44438 0
New Zealand
Phone 44438 0
+64 09 3737599 ext 88917
Fax 44438 0
Email 44438 0
[email protected]
Contact person for public queries
Name 44439 0
Ms Samantha Marsh
Address 44439 0
National Institute for Health Innovation
University of Auckland
Private bag 92019
Auckland, 1142
Country 44439 0
New Zealand
Phone 44439 0
+64 09 3737599 ext 88917
Fax 44439 0
Email 44439 0
[email protected]
Contact person for scientific queries
Name 44440 0
Ms Samantha Marsh
Address 44440 0
National Institute for Health Innovation
University of Auckland
Private bag 92019
Auckland, 1142
Country 44440 0
New Zealand
Phone 44440 0
+64 09 3737599 ext 88917
Fax 44440 0
Email 44440 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

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