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Trial registered on ANZCTR


Registration number
ACTRN12614000163606
Ethics application status
Approved
Date submitted
14/01/2014
Date registered
10/02/2014
Date last updated
12/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a multi-component intervention to reduce screen-time in adolescents:
The ‘Switch-off 4 Healthy Minds’ study
Scientific title
Evaluation of a multi-component intervention to reduce screen-time in adolescents: The ‘Switch-off 4 Healthy Minds’ study
Secondary ID [1] 283900 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 290893 0
Sedentary behaviour 290894 0
Psychological well-being 290895 0
Physical inactivity 290896 0
Condition category
Condition code
Public Health 291246 291246 0 0
Health promotion/education
Diet and Nutrition 291247 291247 0 0
Obesity
Mental Health 291248 291248 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The ‘Switch-off 4 Healthy Minds’ intervention will run for two full school terms, in 2014, and will aim to promote and improve psychological wellbeing in adolescents. The intervention will include a range of evidence-based and innovative strategies to reduce sedentary behaviour in adolescents. The eHealth intervention will include push notifications and text messages promoting a reduction in screen-time. Participants will receive 25 push prompt messages throughout the intervention. Participants will receive these prompts once weekly and will have the opportunity to choose how the messages will be delivered. Delivery methods such as: Facebook, Twitter, Email, Snap Chat and SMS have been chosen due to their popularity in the age group of (i.e.11-12 years). The push-prompt messages (i.e., text messages) will be designed to address the consequences of excessive screen-time and the importance of self-management. The intervention is grounded in self-determination theory and strategies have been designed to influence motivation to limit screen time and potential environmental determinants. An information session will be delivered by a member of research team during school hours. The session will outline the intervention and requirements of the students. Students will be given the opportunity to ask any questions during this session. The intervention will also include a range of strategies for parents to manage their children’s screen-time: (a) screen-time behavioural contract, (b) newsletters focusing on: household screen-time rules, consequences of excessive screen-time, strategies to manage parent/child conflict arising from screen-time rules and home challenges to reduce screen-time. The intervention period will last for 6 months which includes baseline and follow-up assessments. Attendance at workshops will be monitored using class attendance lists. Other strategies used to monitor adherance to the program will be included in the process evaluations conducted at 6-months. Process evaluation questionnaires will determine how many newsletters were read, number of text messages received and satisfaction of the intervention in relation to the different methods of delivery.
Intervention code [1] 288580 0
Prevention
Intervention code [2] 288581 0
Lifestyle
Intervention code [3] 288582 0
Behaviour
Comparator / control treatment
Wait list control. Students in the control group will receive standard treatment during the intervention and will receive the intervention following the 6-month assessments.
Control group
Active

Outcomes
Primary outcome [1] 291244 0
Recreational screen-time will be the primary outcome and will be measured using the Adolescent Sedentary Activity Questionnaire (ASAQ) (Hardy et al, 2007).
Timepoint [1] 291244 0
Baseline and 6-months.
Secondary outcome [1] 306331 0
Psychological well-being will be will be measured using the Strengths and Difficulties Questionnaire (SDQ) total difficulties score (Goodman, 1997 & Mellor, 2005).
Timepoint [1] 306331 0
Baseline and 6-months.
Secondary outcome [2] 306333 0
Psychological distress will be measured using the Kessler 10 Questionnaire (K-10) (Slade et al, 2011).
Timepoint [2] 306333 0
Baseline and 6-months.
Secondary outcome [3] 306334 0
Physical Self-Description Questionnaire: Physical self-concept will be measured using a modified version of the Physical Self-Description Questionnaire (Marsh et al, 1994 & Marsh 1996).
Timepoint [3] 306334 0
Baseline and 6-months.
Secondary outcome [4] 306336 0
Weight and height will be measured in a private location using a portable medical scale and stadiometer. Body mass index and age/gender adjusted z-scores will be calculated.
Timepoint [4] 306336 0
Baseline and 6-months.
Secondary outcome [5] 306337 0
Physical activity will be assessed using GeneACTIV accelerometers (student's normal physical activity at home).
Timepoint [5] 306337 0
Baseline and 6-months.
Secondary outcome [6] 306338 0
Social cognitive and environmental mediators of sedentary behaviour change will be assessed using the Motivation to Limit Screen-time questionnaire (Lubans et al., 2013) and Screen-time rules will be used from a survey developed by Ramirez et al. (2011) will be adapted for the study.
Timepoint [6] 306338 0
Baseline and 6-months.

Eligibility
Key inclusion criteria
Eight Catholic schools located in the Hunter region will be eligible to participate in the study.
All students in year 7 at the study schools will be invited to complete a screen-time eligibility questionnaire. Students who report greater than or equal to 2 hours/day in screen-based recreation will be invited to participate in the study.
Minimum age
11 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Students will be ineligible if they do not complete the consent form.

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)
Participants will be sourced from approximately 8 Catholic schools from the Hunter region.
The School Principal from Catholic schools will be sent an Information and Consent Letter describing the study. If the School Principal declines the study invitation we will contact another school. Once we have recruited a school, participants will learn about the study through a range of mediums including:
- announcements at school assembly
- announcements in PE classes

All students in year 7 at the study schools will be invited to complete a screen-time eligibility questionnaire. Students who report greater than or equal to 2 hours/day in screen-based recreation will be invited to participate in the study.

Eligible students will be invited to an information session at the school describing the study. At this session, interested students will be provided with an Information Letter detailing each intervention, their anticipated benefits, their required commitment level, and a Consent Letter. Our researchers will distribute information sheets and consent forms.
Allocation is not concealed for this study.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Once baseline assessments have been conducted, schools will be randomised to one of two study arms (i) Switch-off 4 Healthy Minds intervention or (ii) Wait list control group. Schools will be randomly allocated to one of the two intervention groups using a computer-based random number-producing algorithm. This method ensures an equal chance of allocation to each group. All participants will be assessed at baseline and at the completion of the intervention (6 months).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Wait list control design. Participants assigned to the control group will receive the intervention following thr 6-months follow-up assessments.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analyses of the primary and secondary outcomes will be conducted with linear mixed models using IBM SPSS Statistics for Windows, Version 20.0 (2010 SPSS Inc., IBM Company Armonk, NY) and alpha levels will be set at p < 0.05. The models will be used to assess the impact of treatment (S4HM or control), time (treated as categorical with levels baseline and 6-months) and the group-by-time interaction, these three terms forming the base model. The models will be specified to adjust for the clustered nature of the data and will include all randomised participants in the analysis. A power calculation was conducted to determine the sample size required to detect changes in the primary outcome [i.e., recreational screen-time from the Adolescent Sedentary Activity Questionnaire (ASAQ)]. Calculations were based on 80% power with alpha levels set at p < 0.05, using an intraclass correlation coefficient (ICC) of 0.03 and a standard deviation of 91 minutes, based on our previous school based studies. Using methods that account for the clustering of effects at the school level, it was calculated that a study sample of N = 320 students (i.e., 40 students from 8 schools) will provide adequate power to detect a between group difference of 48 minutes of recreational screen-time. Sub-group analysis will be conducted for adolescents who were overweight or obese at baseline.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/02/2014
Actual
24/03/2014
Date of last participant enrolment
Anticipated
30/06/2014
Actual
7/05/2014
Date of last data collection
Anticipated
Actual
8/12/2014
Sample size
Target
320
Accrual to date
Final
322
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 288543 0
Charities/Societies/Foundations
Name [1] 288543 0
Hunter Medical Research Institute (HMRI)
Country [1] 288543 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
The University of Newcastle (UoN)
University Drive
Callaghan NSW 2308
Australia
Country
Australia
Secondary sponsor category [1] 287253 0
Individual
Name [1] 287253 0
A/Prof David Lubans
Address [1] 287253 0
Priority Research Centre in Physical Activity & Nutrition
Level 3 ATC
The University of Newcastle (UoN)
University Drive
Callaghan NSW 2308
Australia
Country [1] 287253 0
Australia
Secondary sponsor category [2] 287254 0
Individual
Name [2] 287254 0
Prof Philip Morgan
Address [2] 287254 0
Priority Research Centre in Physical Activity & Nutrition
Level 3 ATC
The University of Newcastle (UoN)
University Drive
Callaghan NSW 2308
Australia
Country [2] 287254 0
Australia
Secondary sponsor category [3] 287255 0
Individual
Name [3] 287255 0
Mrs Narelle Eather
Address [3] 287255 0
Priority Research Centre in Physical Activity & Nutrition
Level 3 ATC
The University of Newcastle (UoN)
University Drive
Callaghan NSW 2308
Australia
Country [3] 287255 0
Australia
Other collaborator category [1] 277755 0
Individual
Name [1] 277755 0
Prof Ron Plotnikoff
Address [1] 277755 0
Priority Research Centre in Physical Activity & Nutrition
Level 3 ATC
The University of Newcastle (UoN)
University Drive
Callaghan NSW 2308
Australia
Country [1] 277755 0
Australia
Other collaborator category [2] 277756 0
Individual
Name [2] 277756 0
Prof Amanda Baker
Address [2] 277756 0
School of Medicine and Public Health
The University of Newcastle (UoN)
University Drive
Callaghan NSW 2308
Australia
Country [2] 277756 0
Australia
Other collaborator category [3] 277757 0
Individual
Name [3] 277757 0
Dr Geoff Skinner
Address [3] 277757 0
School of Design Communication and IT
The University of Newcastle (UoN)
University Drive
Callaghan NSW 2308
Australia
Country [3] 277757 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290408 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 290408 0
Research Services
Research Office
The University of Newcastle (UoN)
University Drive
Callaghan NSW 2308
Australia
Ethics committee country [1] 290408 0
Australia
Date submitted for ethics approval [1] 290408 0
18/12/2013
Approval date [1] 290408 0
07/02/2014
Ethics approval number [1] 290408 0
H-2013-0428

Summary
Brief summary
The primary aim of this group randomised control trial is to evaluate the impact of an innovative multi-component intervention to reduce sedentary behaviour (i.e. time spent sitting) on health and psychological well-being in adolescents.

The project will address the following research questions:

i) What is the impact of the intervention on the primary outcome of recreational screen-time?
ii) What is the impact of the intervention on the secondary outcomes of psychological wellbeing, obesity, physical activity and sleep time?
iii) What are the factors responsible (i.e., mediators) for sedentary behaviour change?
iv) What is the feasibility and acceptability of the intervention among students, parents and teachers?

The study will include a range of different strategies including:
(a) e-Health delivered intervention messages and an,
(b) Information session.
The intervention will also include a range of strategies for parents to manage their children’s screen-time:
(c) screen-time behavioural contract, and
(d) newsletters focusing on household screen-time rules, consequences of excessive screen-time, strategies to manage parent/child conflict arising from screen-time rules and home challenges to reduce screen-time.
Recreational screen-time will be the primary outcome of the study. Secondary outcomes include: psychological well-being, physical self-concept, psychological distress, weight, height and physical activity. Social cognitive and environmental mediators of sedentary behaviour change will be also be assessed.
Assessments will be conducted at baseline and 6-months.
Trial website
No website currently available.
Trial related presentations / publications
none
Public notes

Contacts
Principal investigator
Name 45522 0
A/Prof David Lubans
Address 45522 0
Priority Research Centre for Physical Activity and Nutrition
Level 3 ATC Building
The University of Newcastle (UoN)
University Drive
Callaghan NSW 2308
Country 45522 0
Australia
Phone 45522 0
+61 2 4921 2049
Fax 45522 0
+61 2 4921 2084
Email 45522 0
[email protected]
Contact person for public queries
Name 45523 0
David Lubans
Address 45523 0
Priority Research Centre for Physical Activity and Nutrition
Level 3 ATC Building
The University of Newcastle (UoN)
University Drive
Callaghan NSW 2308
Country 45523 0
Australia
Phone 45523 0
+61 2 4921 2049
Fax 45523 0
+61 2 4921 2084
Email 45523 0
[email protected]
Contact person for scientific queries
Name 45524 0
David Lubans
Address 45524 0
Priority Research Centre for Physical Activity and Nutrition
Level 3 ATC Building
The University of Newcastle (UoN)
University Drive
Callaghan NSW 2308
Country 45524 0
Australia
Phone 45524 0
+61 2 4921 2049
Fax 45524 0
+61 2 4921 2084
Email 45524 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
SourceTitleYear of PublicationDOI
EmbaseIntervention to reduce recreational screen-time in adolescents: Outcomes and mediators from the 'Switch-Off 4 Healthy Minds' (S4HM) cluster randomized controlled trial.2016https://dx.doi.org/10.1016/j.ypmed.2016.07.014
N.B. These documents automatically identified may not have been verified by the study sponsor.