Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000526279
Ethics application status
Approved
Date submitted
23/02/2018
Date registered
10/04/2018
Date last updated
27/02/2020
Date data sharing statement initially provided
11/03/2019
Date results provided
11/03/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Thirsty? Choose Water!
Behavioural Interventions and Water Stations in secondary schools
Scientific title
Thirsty? Choose Water! The Effect of Behavioural Interventions and Water Stations on water consumption in secondary schools: A two-by-two factorial randomised controlled trial.
Secondary ID [1] 294025 0
NSW Ministry Of Health, Translation Research Grants Scheme
TRGS Application Number: 152
Project Title:
Thirsty? Choose Water - Year 7 Immunisation Intervention
Universal Trial Number (UTN)
U1111-1209-7151
Trial acronym
TCW
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Childhood obesity 306558 0
Condition category
Condition code
Public Health 305654 305654 0 0
Health promotion/education
Diet and Nutrition 305913 305913 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will assess the effect of two interventions designed to increase water consumption and effect changes in knowledge, attitudes or consumption of sugar sweetened beverages (SSBs) in year 7 secondary school students. Both interventions will take place in the secondary school setting.
Schools recruited to the study will be randomised to one of four study arms:
ARM 1 - the Thirsty Choose Water Behavioral Intervention
ARM 2 - Chilled water stations,
ARM 3 - the Thirsty Choose Water Behavioral Intervention and chilled water stations, or
ARM 4 - Neither intervention (control arm).
The first intervention is a behavioral intervention based on the Health Promoting Schools Framework. The health promoting schools framework has been well utilised in school settings to target a wide range of health issues. When using the health promoting schools framework to deliver health education all three domains of the framework must be addressed. These include promoting or delivering the health message or topic through the school curriculum, the school organisation, ethos and environment and the partnerships and service (formally families and/or communities) domain. There is good evidence that interventions utilising the Health Promoting Schools Framework have positive outcomes. A recent Cochrane systematic review demonstrated modest positive intervention effects on range of health indicators.
The use of the Heath Promoting Schools framework adds strength to the Thirsty Choose Water behavioural intervention and aligns with an accepted way of working with schools. The behavioural intervention will occur over two school terms (term 3 and 4) targeting each domain of the health promoting schools framework, and will provide information about SSBs (eg SSBs sugar content, negative health effects of SSBs, physical activity required to burn off consumed SSBs etc) to increase student knowledge and awareness and promote water as a preferred drink.
Within the curriculum, teaching and learning domain year students will receive the intervention in the classroom through the inclusion of messages in year 7 Personal Development, Health and Physical Activity (PDHPE) lessons. PDHPE teachers will deliver two 50 minute lessons. Project officers will liaise with teaching and immunisation staff to ensure that where possible the delivery of these lessons coincides with the delivery of the thirsty messages through the immunisation clinic (partnerships and services domain). PDHPE teachers will receive two PDHPE lesson plans and a resources pack, which were developed in consultation with PDHPE teachers. These lesson plans outline the key water messages as well as a goal based activity for students to decrease their consumption of SSBs and increase their water consumption. To support the implementation of these lesson plans within the PDHPE curriculum professional development opportunities for teaching staff will also be provided. This professional development will be face to face workshop, provided by the health promotion team, a number of who have teaching backgrounds. This professional development will be offered in term 2.
The school organisation ethos and environment domain will be addressed by messaging through posters, school newsletters, school social media and other opportunities identified locally by schools to engage students and their families (potentially reaching students in other years)(term 3 and 4).
The partnerships and services domain will be addressed through a partnership between schools and local immunisation teams. This provides an opportunistic avenue for the Thirsty Choose Water messages to be further targeted to year 7 students. When students attend the immunisation clinic the thirsty messages will be promoted through a number of avenues. Banners will display the thirsty messages, which include information about the sugar contents of sugar sweetened beverages, and a distractor card including the thirsty messages will be used as students receive their immunisation. Students will be given a guitar pick following their immunisation, which acts a playing marker for the “Spouts and Straws” (snakes and ladders) game. In the 10-15 minute post immunisation waiting period immunisation nurses direct students to participate in this game which introduces messages about the benefits of water consumption and the negative health effects of SSBs. This post immunisation waiting period provides an additional opportunity for students to receive the message. The guitar pick that students use as the playing marker also has the web address of the thirsty choose water website, where students can access further information http://www.healthpromotion.com.au/choosewater/More_Info.html. Whilst year 7 students attend 3 immunisation clinics over the course of the school year, the Thirsty intervention is only offered at the last immunisation clinic. Depending on the immunisation schedule for specified schools students will be provided the thirsty messages through the immunisation clinic in either term 3 or 4.
Monitoring adherence to the behavioural intervention will be achieved via Project Officers regularly liaising with participating schools to gather feedback on the lesson implementation and the immunisation components, forming part of the process evaluation of the study. At the end of the study teachers and nurses will also complete feedback surveys. Web statistics can also be analysed to determine access to the website.
The second intervention is the provision and installation of chilled water stations. Evidence suggests that providing water fountains and water bottles has been shown to increase water consumption in children and decrease the incidence of overweight in children. Project Officers will work closely will those schools who are receiving a chilled water station to determine the location and installation of the water station. The installation of chilled water stations will occur once baseline data has been collected. Where practical they will be installed within similar time frames. Local consultation with schools will determine the most appropriate location for the chilled water station, which has access to water, power and drainage. A remote water monitoring system will be added to record the flow of water from these chilled water stations. It is anticipated that chilled water stations will be installed in term 2 and water flow monitoring will commence at the time of installation. Each school in Arm 2 and 3 of the study will receive one chilled water station, regardless of student population, and this information will be accounted for in the analysis of the study finding. Schools will retain the chilled water station following the completion of the study, but the remote water monitoring system will be removed.

Intervention code [1] 300419 0
Lifestyle
Intervention code [2] 300477 0
Prevention
Intervention code [3] 300478 0
Behaviour
Comparator / control treatment
The control group will receive no intervention or changes within their school. They will be involved in the evaluation of the study only. Once schools are recruited to the study they will be randomly allocated to one of the four arms.
Control group
Active

Outcomes
Primary outcome [1] 304894 0
Primary outcome 1: is the change in the proportion of year 7 students drinking 5 or more cups of water per day. This measure is based on data from the 2011 NSW School Students Health Behaviour Survey.

This outcome will be measured utilising the student self-report survey - the student self-report survey is composed of both validated questions from the NSW School Physical Activity and Nutrition Survey (SPANS) and questions specifically designed for this study. A validated question from the SPANS survey will specifically ask students about the number of cups of water per day they drink.
Timepoint [1] 304894 0
Primary timepoint 1: The student self-report survey will be administered at baseline (Term 2, 2018) , post intervention (Term 4, 2018) and follow-up (Term 1, 2019), providing an indication of the number of cups of water consumed.
Primary outcome [2] 305396 0
Primary outcome 2: The average amount of water consumed per day by a Year 7 student, as measured from chilled water stations. Water meters and data loggers will be installed on the water stations to allow remote monitoring of water flow, which will be measured consecutively post the installations of chilled water stations.
Timepoint [2] 305396 0
Primary timepoint 2: Estimates of average daily water consumption per Year 7 student will be collected continuously, commencing in term 2, 2018 (i.e. baseline) and concluding in term 1, 2019 (final follow-up).
Secondary outcome [1] 343551 0
changes in students’ knowledge regarding sugar sweetened beverages as assessed through student surveys. The questions assessing knowledge were written specifically for this survey.
Timepoint [1] 343551 0
This secondary outcome will be measured at baseline (term 2, 2018) , post intervention (term 4, 2018) and follow-up (Term 1, 2019).
Secondary outcome [2] 344626 0
Changes in students’ attitudes regarding sugar sweetened beverages as assessed through student surveys. The questions assessing attitudes were written specifically for this survey.

Timepoint [2] 344626 0
This secondary outcome will be measured at baseline (term 2, 2018) , post intervention (term 4, 2018) and follow-up (Term 1, 2019).
Secondary outcome [3] 344627 0
Changes in students’ consumption of sugar sweetened beverages as assessed through student surveys. These surveys include validated questions from the NSW School Physical Activity and Nutition Survey (SPANS)( 2015). This question specfically asks how frequently sugar sweetened beverages are consumed.
Timepoint [3] 344627 0
This secondary outcome will be measured at baseline (term 2, 2018) , post intervention (term 4, 2018) and follow-up (Term 1, 2019).

Eligibility
Key inclusion criteria
The study is to be conducted across three New South Wales Local Health Districts and all Public, Catholic and Independent secondary schools (except schools for special purposes for example schools for students with behavioural difficulties) within the boundaries of these Local Health Districts will be invited to participate.
Minimum age
12 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Schools that already have adequate chilled water stations in situ (one per 300 students) will be excluded from participating in the study.

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)
Allocation concealment occurred. The Project Officer who determined if a school was eligible for inclusion in the trial was unaware when this decision was made, to which group the subject would be allocated. Subsequently the details of schools who agree to participate in the study will be provided to the study statistician, who will subsequently allocate schools to their study group through the use of randomization by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation) will be used to randomly allocate recruited schools to each of the four study Arms
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size and power calculations
Power calculations were conducted to determine the sample size required to detect a change of 5% or more in the primary outcome, that being the proportion of students drinking 5 or more cups of water per day. Change was defined as the difference between the proportion at baseline, assumed to be 40% (as shown in the 2011 School Students Health Behaviour Survey and at final follow-up. The calculation assumed normality for the outcome, with alpha set at 5% and beta set at 20% [i.e. power = 80%]. In applying power calculations we took into account students being clustered in schools. Using these inputs and prior to an adjustment by design effect for correlated data, it was calculated that an effective sample of 761 students would be needed. Given an assumed intraclass correlation of 0.055 (calculated based on water consumption data from the NSW Schools Physical Activity and Nutrition Survey (SPANS) 2015) and an average school year 7 cohort of 135, this figure was then adjusted by a design factor of 8.37, thus putting the required number of students at 6,370, being equivalent to 48 schools. This figure increases to 60, when an expected non-response of 20% at the school level is taken into account; meaning 15 schools would be randomly allocated to each treatment arm. With the number of schools available for selection within each of the three health districts being unequal, proportional sampling would also be needed (rather than a balanced design), resulting in 18 schools being invited from CCLHD, 22 from ISLHD and 20 from SWSLHD.

Statistical analysis plan
Descriptive statistics will be used to summarise study variables. Categorical variables will be reported as counts and proportions. If normally distributed, continuous variables will be presented as means and standard deviations. Otherwise, they will be presented as medians and interquartile ranges.

Baseline characteristics of study arms will be compared to assess similarity at study entry, thereby allowing for the identification of significant imbalances requiring adjustment during analysis. If continuous, differences will be assessed using two-sample t-test or Mann-U Whitney tests for data with non-normal distributions. Categorical variables will be analysed by Pearson chi-squared tests or Fisher’s exact test.

To account for clustering at the LHD and school level and the capture of longitudinal data, multi-level regression models with mixed effects will be built to estimate interventional effect. For each model building process, variables found to be significantly associated with the outcome measure in the univariable analysis at the 10% level will be retained in the final model. As the primary predictor of interest, intervention effect will be forced into the multivariable model in the form of 4-level categorical variable. Continuous outcome measures will be analysed using linear regression models. For binary outcome measures, analysis will be by binary logistic regression, while multinominal logistic regression will be used to analyse non-binary categorical measures. Model diagnostics will be conducted on all models to ascertain their appropriateness. Each model will be tested for violations of model assumptions, existence of influential points and goodness of fit. Tests for all outcomes will be two-tailed, with levels of statistical significance set at 5%.

Statistical analysis will be performed using Stata 14.2 (StataCorp LP, College Station, Texas) statistical software.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
6/02/2018
Date of last participant enrolment
Anticipated
13/04/2018
Actual
13/04/2018
Date of last data collection
Anticipated
12/04/2019
Actual
12/04/2019
Sample size
Target
8100
Accrual to date
Final
9000
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 10088 0
Gosford Hospital - Gosford
Recruitment hospital [2] 10089 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 10090 0
Wollongong Hospital - Wollongong
Recruitment postcode(s) [1] 21624 0
2250 - Gosford
Recruitment postcode(s) [2] 21625 0
2170 - Liverpool
Recruitment postcode(s) [3] 21626 0
2500 - Wollongong

Funding & Sponsors
Funding source category [1] 298652 0
Government body
Name [1] 298652 0
NSW Ministry of Health Translation Research Grants Scheme (TRGS),
Country [1] 298652 0
Australia
Funding source category [2] 305093 0
Government body
Name [2] 305093 0
Medical Research Future Fund
Country [2] 305093 0
Australia
Primary sponsor type
Government body
Name
Central Coast Local Health District
Address
Level 1, 4-6 Watt Street,
Gosford
NSW 2250
Country
Australia
Secondary sponsor category [1] 298259 0
None
Name [1] 298259 0
None
Address [1] 298259 0
Country [1] 298259 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299606 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 299606 0
Ethics committee country [1] 299606 0
Australia
Date submitted for ethics approval [1] 299606 0
17/08/2017
Approval date [1] 299606 0
12/12/2017
Ethics approval number [1] 299606 0
17/08/16/4.07)
Ethics committee name [2] 299710 0
NSW Department of Education
Ethics committee address [2] 299710 0
Ethics committee country [2] 299710 0
Australia
Date submitted for ethics approval [2] 299710 0
19/09/2017
Approval date [2] 299710 0
08/12/2017
Ethics approval number [2] 299710 0
SERAP2017457
Ethics committee name [3] 299711 0
Catholic Education Office, Diocese of Wollongong
Ethics committee address [3] 299711 0
Ethics committee country [3] 299711 0
Australia
Date submitted for ethics approval [3] 299711 0
18/09/2017
Approval date [3] 299711 0
29/09/2017
Ethics approval number [3] 299711 0
approval letter only
Ethics committee name [4] 299712 0
Sydney Catholic Schools Research Centre
Ethics committee address [4] 299712 0
Ethics committee country [4] 299712 0
Australia
Date submitted for ethics approval [4] 299712 0
08/09/2017
Approval date [4] 299712 0
12/10/2017
Ethics approval number [4] 299712 0
REF 201727:
Ethics committee name [5] 299713 0
Broken Bay Diocese
Ethics committee address [5] 299713 0
Ethics committee country [5] 299713 0
Australia
Date submitted for ethics approval [5] 299713 0
20/09/2017
Approval date [5] 299713 0
06/11/2017
Ethics approval number [5] 299713 0
Ref 17-018
Ethics committee name [6] 305483 0
Catholic Schools Office - Diocese Maitland-Newcastle
Ethics committee address [6] 305483 0
Ethics committee country [6] 305483 0
Australia
Date submitted for ethics approval [6] 305483 0
03/12/2018
Approval date [6] 305483 0
18/12/2018
Ethics approval number [6] 305483 0

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

Contacts
Principal investigator
Name 81006 0
Mrs Niki Kajons
Address 81006 0
Health Promotion Service, Central Coast Local Health District
Level 1, 4-6 Watt Street,
Gosford NSW 2250

PO Box 361
Gosford NSW 2250
Country 81006 0
Australia
Phone 81006 0
+61 2 4320 9700
Fax 81006 0
+61 2 4320 9725
Email 81006 0
[email protected]
Contact person for public queries
Name 81007 0
Niki Kajons
Address 81007 0
Health Promotion Service, Central Coast Local Health District
Level 1, 4-6 Watt Street,
Gosford NSW 2250

PO Box 361
Gosford NSW 2250
Country 81007 0
Australia
Phone 81007 0
+61 2 4320 9700
Fax 81007 0
+61 2 4320 9725
Email 81007 0
[email protected]
Contact person for scientific queries
Name 81008 0
Niki Kajons
Address 81008 0
Health Promotion Service, Central Coast Local Health District
Level 1, 4-6 Watt Street,
Gosford NSW 2250

PO Box 361
Gosford NSW 2250
Country 81008 0
Australia
Phone 81008 0
+61 2 4320 9700
Fax 81008 0
+61 2 4320 9725
Email 81008 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No - ethical clearances for the study state that this information will remain confidential.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1572Study protocol    https://www.ncbi.nlm.nih.gov/pubmed/29940902 374487-(Uploaded-11-03-2019-14-39-22)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Gowland-Ella, J., Kajons, N., David, M., Lewis, P.... [More Details]
Study results articleYes Gowland-Ella, J., et al. (2022). "The outcomes of ... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThirsty? Choose Water! Behavioural interventions and water stations in secondary schools a two-by-two factorial randomised controlled trial.2018https://dx.doi.org/10.1186/s12889-018-5685-1
N.B. These documents automatically identified may not have been verified by the study sponsor.