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Trial registered on ANZCTR


Registration number
ACTRN12618001731280
Ethics application status
Approved
Date submitted
17/10/2018
Date registered
22/10/2018
Date last updated
20/03/2019
Date data sharing statement initially provided
12/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A cluster randomised controlled trial to improve the lunchbox contents of primary school aged children.
Scientific title
A cluster randomised controlled trial to evaluate the efficacy of a school-based program, primarily delivered using an existing school communication application, in improving the nutritional quality of foods and drinks packed in lunchboxes of primary school aged children.
Secondary ID [1] 296333 0
None
Universal Trial Number (UTN)
Trial acronym
SWAP IT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nutrition 310048 0
Child obesity 310049 0
Condition category
Condition code
Public Health 308800 308800 0 0
Health promotion/education
Diet and Nutrition 308801 308801 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The lunchbox program aims to improve the contents of children’s lunchboxes by supporting parents/carers to swap what is packed from discretionary (“sometimes”) foods and drinks to core (“everyday”) foods and drinks. Core foods are defined as minimally processed foods from the five food groups set out in the Australian Dietary Guidelines, and discretionary foods are those not consistent with the Dietary Guidelines and tending to be higher in fat, sugar and salt and poorer in nutritional quality. The program seeks to address the barriers faced by parents to packing a healthy lunchbox (time/convenience, cost, child preference, food safety and knowledge).

Schools will be randomly allocated to either the program group or a waitlist control group. The program will run for approximately 15 weeks and includes 4 key strategies:

1. Lunchbox nutrition guidelines – an experienced public health nutritionist will work with program schools to develop lunchbox nutrition guidelines. Principal endorsement of guidelines will be promoted to the school community utilising the authority of the school principal, to communicate school expectations and normalise healthy lunchboxes. To assess implementation fidelity, principals will be asked about the guidelines and methods used to inform parents during a post-program interview.

2. Weekly support messages – Following the development of lunchbox nutrition guidelines, weekly messages (developed by Public Health Nutritionists) will be “pushed” to parents using the existing school communication application for a period of 10 school weeks. These messages address the identified barriers to packing a healthy lunchbox and act as prompts and cues to reinforce the packing of everyday foods. Content may include short word messages, relevant pictures, links to videos and project website and an email address to request further information. Implementation fidelity (ie. delivery of messages) will be ascertained through accessing app analytics.

3. Resources for parents – To coincide with the first support message, children will receive a magnetised parent resource booklet, designed by public health nutritionists for the SWAP IT program, as well as a branded ice brick and a water bottle. These resources aim to facilitate the packing of healthy lunchboxes. Hyperlinks embedded in the app messages will connect parents to additional resources, created by public health nutritionists for the SWAP IT program, accessible via the Good for Kids website. To assess implementation fidelity, parents will be asked questions relating to the resources during a telephone survey at the completion of the program and website analytics will be collected to monitor website traffic.

4. Resources for schools - Schools will be sent complimentary stage appropriate curriculum resources that align with syllabus outcomes. These resources were developed for the SWAP IT program by school teachers and public health nutritionists, for use by teachers to reinforce healthy food preferences and improve student’s nutrition knowledge. Schools will be encouraged to deliver the lessons at a time appropriate to them during the 15 week program. Schools will also be asked to display 10 pictorial posters (one per week) in school classrooms to coincide with the weekly support messages for parents. These posters show examples of healthy lunchboxes and include tips to address the known barriers. These posters were designed for the program by public health nutritionists to act as prompts for teachers to facilitate discussion of lunchbox ideas with students. To assess implementation fidelity, teachers will be asked questions relating to the delivery of curriculum resources and posters during a post-program survey.
Intervention code [1] 312660 0
Prevention
Intervention code [2] 312661 0
Lifestyle
Intervention code [3] 312662 0
Behaviour
Comparator / control treatment
Usual practice (no program) – consisting of usual school practices towards healthy eating in the school community, which may or may not include professional development opportunities for teachers, resources, and/or school policies.

Schools allocated to the waitlist control group will participate in data collection only. Support and program materials will be available following the final data collection timepoint (approximately 9 months post baseline).
Control group
Active

Outcomes
Primary outcome [1] 307786 0
The mean kilojoule (kJ) content of discretionary foods and drinks packed in children’s lunchboxes of parents who use a school mobile application. This will be assessed from photos of lunchboxes, taken prior to the first meal break, via a valid and reliable lunchbox observational audit tool, known as the School Food Checklist (SFC).
Timepoint [1] 307786 0
Baseline and immediately post intervention (approximately 6 months post baseline) (primary timepoint); and again at approximately 9 months post baseline.
Secondary outcome [1] 352873 0
The mean kilojoule (kJ) content of discretionary foods and drinks consumed from children’s lunchboxes in a subsample of students of parents who use a school mobile application. This will be assessed from photos of lunchboxes, taken prior to the first meal break and at the completion of the final meal break, via a valid and reliable lunchbox observational audit tool (SFC).
Timepoint [1] 352873 0
Baseline and immediately post intervention (approximately 6 months post baseline); and again at approximately 9 months post baseline.
Secondary outcome [2] 352874 0
Percent energy from discretionary foods and drinks consumed from children’s lunchboxes of parents who use a school mobile application. This will be assessed from photos of lunchboxes, taken prior to the first meal break and at the completion of the final meal break, via a valid and reliable lunchbox observational audit tool (SFC).
Timepoint [2] 352874 0
Baseline and immediately post intervention (approximately 6 months post baseline); and again at approximately 9 months post baseline.
Secondary outcome [3] 352875 0
Percent energy from discretionary foods and drinks packed in children’s lunchboxes of parents who use a school mobile application. This will be assessed from photos of lunchboxes, taken prior to the first meal break, via a valid and reliable lunchbox observational audit (SFC).
Timepoint [3] 352875 0
Baseline and immediately post intervention (approximately 6 months post baseline); and again at approximately 9 months post baseline.
Secondary outcome [4] 352876 0
Mean total kilojoule (kJ) content of foods consumed from lunchboxes of parents who use a school mobile application. This will be assessed from photos of lunchboxes, taken prior to the first meal break and at the completion of the final meal break, via a valid and reliable lunchbox observational audit tool (SFC).
Timepoint [4] 352876 0
Baseline and immediately post intervention (approximately 6 months post baseline); and again at approximately 9 months post baseline.
Secondary outcome [5] 352877 0
Mean total kilojoule (kJ) content of foods packed in lunchboxes of parents who use a school mobile application. This will be assessed from photos of lunchboxes, taken prior to the first meal break, via a valid and reliable lunchbox observational audit tool (SFC).
Timepoint [5] 352877 0
Baseline and immediately post intervention (approximately 6 months post baseline); and again at approximately 9 months post baseline.
Secondary outcome [6] 352884 0
Student engagement will be measured using the School Engagement Measurement (SEM) in students in Grades 5 and 6 of parents who use a school mobile application. The survey will be completed in class time and facilitated by a trained research assistant.
Timepoint [6] 352884 0
Baseline and immediately post intervention (approximately 6 months post baseline).
Secondary outcome [7] 352988 0
Mean cost of lunchbox contents, measured in dollars and cents of parents who use a school mobile application. This will be assessed via the SFC. A cost, determined by averaging the price from foods, obtained in October 2016, contained within the category, is assigned to each food category within the SFC.
Timepoint [7] 352988 0
Baseline and immediately post intervention (approximately 6 months post baseline).
Secondary outcome [8] 352989 0
Incremental cost per unit change in mean kJ content of foods as assessed by the SFC of parents who use a school mobile application.
Timepoint [8] 352989 0
Baseline and immediately post intervention (approximately 6 months post baseline).
Secondary outcome [9] 352990 0
Student dietary intake outside of school hours, of parents who use a school mobile application, via a telephone survey of parents to assess potential displacement effects ; assessed via dietary questions from the School Physical Activity and Nutrition Survey (SPANS) and the Junk Food Intake Measure (JFIM).
Timepoint [9] 352990 0
Baseline and immediately post intervention (approximately 6 months post baseline).
Secondary outcome [10] 353076 0
Assessment of parents’ usual dietary intake, of parents who use a school mobile application, via a telephone survey with parents, assessed via items from the NSW Population Health Survey Questionnaire 2017 .
Timepoint [10] 353076 0
Baseline and immediately post intervention (approximately 6 months post baseline).
Secondary outcome [11] 353077 0
Assessment of student overall energy and dietary intake, of parents who use a school mobile application, to determine any potentially meaningful effects of the intervention on overall diet, assessed via a food frequency questionnaire (ACAES).
Timepoint [11] 353077 0
Baseline and immediately post intervention (approximately 6 months post baseline).
Secondary outcome [12] 366813 0
The mean kilojoule (kJ) content of everyday foods and drinks consumed from children’s lunchboxes of parents who use a school mobile application. This will be assessed from photos of lunchboxes, taken prior to the first meal break and at the completion of the final meal break, via a valid and reliable lunchbox observational audit tool, known as the School Food Checklist (SFC).
Timepoint [12] 366813 0
Baseline and immediately post intervention (approximately 6 months post baseline); and again at approximately 9 months post baseline.
Secondary outcome [13] 366814 0
The mean kilojoule (kJ) content of everyday foods and drinks packed in children’s lunchboxes of parents who use a school mobile application. This will be assessed from photos of lunchboxes, taken prior to the first meal break, via a valid and reliable lunchbox observational audit tool (SFC).
Timepoint [13] 366814 0
Baseline and immediately post intervention (approximately 6 months post baseline); and again at approximately 9 months post baseline.
Secondary outcome [14] 366815 0
Percent energy from everyday foods and drinks consumed from children’s lunchboxes of parents who use a school mobile application. This will be assessed from photos of lunchboxes, taken prior to the first meal break and at the completion of the final meal break, via a valid and reliable lunchbox observational audit tool (SFC).
Timepoint [14] 366815 0
Baseline and immediately post intervention (approximately 6 months post baseline); and again at approximately 9 months post baseline.
Secondary outcome [15] 366816 0
Percent energy from everyday foods and drinks packed in children’s lunchboxes of parents who use a school mobile application. This will be assessed from photos of lunchboxes, taken prior to the first meal break, via a valid and reliable lunchbox observational audit (SFC).
Timepoint [15] 366816 0
Baseline and immediately post intervention (approximately 6 months post baseline); and again at approximately 9 months post baseline.

Eligibility
Key inclusion criteria
Department of Education (DoE) primary schools located in one of the participating local health districts (Hunter New England; Mid North Coast; Central Coast) will be invited to participate. Schools must currently be using the school communication application and have greater than 120 student enrolments.

All students at eligible schools will be invited to participate.
Minimum age
4 Years
Maximum age
13 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Schools with secondary students aged 13-18 years, schools catering exclusively for children requiring specialist care, and/or schools already involved in a nutrition or physical activity trial will be ineligible.

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)
Schools: A random sample of eligible schools will be sent an invitation to participate in the trial. One week after the invitation is sent to schools, the principal will be contacted by phone by an experienced health promotion officer and a face to face meeting will be requested to outline the study requirements and request school consent. Signed consent forms from principals will be sought to confirm school participation.

Parents and children: Following recruitment of schools, all parents with a child enrolled in Kindergarten to Year 6 in the consenting schools will be invited to participate in the study evaluation measures. Students will be provided an information package containing a letter outlining the study and a consent form for parents. Active parental consent will be required for child participation and parents will be asked, via the consent form, if they are an active user of the school communication app. One week following distribution of the information package, parents who have not returned a consent form will be phoned by school staff to invite participation. A replacement consent form will be sent to parents who provide verbal consent.

Randomisation and blinding: Following baseline data collection, schools will be randomised to an intervention or control group via block randomisation on a 1:1 ratio using a computerized random number function. Randomisation will be undertaken by a statistician not involved in contacting schools or in the study intervention or assessment. Data collectors and lunchbox analysis dietitians will be blind to group allocation at baseline. Due to the nature of the intervention, data collectors and lunchbox analysis dietitians will be aware of group allocation following baseline data collection. School staff will also be aware of their group allocation and school principals will be notified of their group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Schools that consent to participate will be randomised into the intervention or control group using a computerised random number function in Microsoft Excel by an independent statistician not involved in recruitment, intervention or assessment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size and power calculations: Based on pilot results, a standard lunchbox contains 1089 kJ (SD=900kJ) from discretionary foods. With an ICC of 0.05, 36 schools with 140 students per school will enable detection of a 200kJ difference between groups at follow up on the primary trial outcome, with 80% power at the 0.05 significance level.

Analysis: All statistical analyses will be performed using SAS (version 9.3) statistical software. Using intention to treat principles, differences between groups in outcomes will be assessed using hierarchical linear (or logistic for binary outcomes) regression models, adjusting for pre-specified prognostic variables and random effects for repeated measures on students. Missing data will be imputed using multiple imputation methods. All statistical tests will be two tailed with an alpha of 0.05. Exploratory subgroup analyses will be conducted by age, gender, SES and frequency of school mobile application use.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 300937 0
Government body
Name [1] 300937 0
NSW Ministry of Health - Translational Research Grants Scheme
Address [1] 300937 0
NSW Ministry of Health
Translational Research Grants Scheme
Locked Mail Bag 961
North Sydney NSW 2059
Country [1] 300937 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Population Health
Address
Locked Bag 10
Wallsend NSW 2287
Country
Australia
Secondary sponsor category [1] 300559 0
None
Name [1] 300559 0
Address [1] 300559 0
Country [1] 300559 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301703 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 301703 0
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 301703 0
Australia
Date submitted for ethics approval [1] 301703 0
06/08/2018
Approval date [1] 301703 0
23/08/2018
Ethics approval number [1] 301703 0
0607264.04

Summary
Brief summary
The aim of this randomised control trial is to evaluate the efficacy of a lunchbox program on the nutritional content of student lunchboxes. 36 primary schools in the Hunter New England, Central Coast and Mid North Coast regions will be randomly allocated to either the program group or a waitlist control group. The program aims to support parents/carers to swap what is packed in lunchboxes from sometimes to everyday food through the development of school lunchbox guidelines, weekly support messages delivered through a school communication app and resources for parents and schools.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87822 0
A/Prof Luke Wolfenden
Address 87822 0
Hunter New England Population Health
Locked Bag 10
Wallsend, NSW 2287
Country 87822 0
Australia
Phone 87822 0
+61 2 4924 6499
Fax 87822 0
Email 87822 0
Luke.Wolfenden@hnehealth.nsw.gov.au
Contact person for public queries
Name 87823 0
Dr Rachel Sutherland
Address 87823 0
Hunter New England Population Health
Locked Bag 10
Wallsend, NSW 2287
Country 87823 0
Australia
Phone 87823 0
+61 2 4924 6499
Fax 87823 0
Email 87823 0
Rachel.Sutherland@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 87824 0
Dr Rachel Sutherland
Address 87824 0
Hunter New England Population Health
Locked Bag 10
Wallsend, NSW 2287
Country 87824 0
Australia
Phone 87824 0
+61 2 4924 6499
Fax 87824 0
Email 87824 0
Rachel.Sutherland@hnehealth.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Ethical approval
Summary results
No Results