Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001289101
Ethics application status
Approved
Date submitted
10/09/2019
Date registered
19/09/2019
Date last updated
15/10/2019
Date data sharing statement initially provided
19/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Can an app-based intervention targeting parents, with or without additional support, improve the nutritional quality of foods and drinks packed in lunchboxes of primary school aged children.
Scientific title
A cluster randomised trial to evaluate the efficacy of an app-based support program or an app-based support program with additional support (school lunchbox guidelines, classroom curriculum and physical resources) in improving the lunchbox contents of primary school aged children.
Secondary ID [1] 299229 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
A cluster randomised controlled trial to improve the lunchbox contents of primary school aged children (ACTRN12618001731280) is the parent study. This current trial is a follow-up study from the parent study, utilising the control schools.

Health condition
Health condition(s) or problem(s) studied:
Nutrition 314353 0
Child obesity 314354 0
Condition category
Condition code
Public Health 312688 312688 0 0
Health promotion/education
Diet and Nutrition 312689 312689 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A cluster randomised trial design will be utilised to test the efficacy of an app only intervention (low dose) in comparison to an app plus school guidelines, classroom curriculum and physical resource (full dose) intervention in improving the nutritional quality of foods and drinks packed in the lunchbox.

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. 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 one of two intervention groups. The program will run for approximately 10 weeks (one school term).

The low dose intervention group will receive a 10 week program which includes weekly support messages delivered to parents using an existing school communication app and a magnetised parent resource booklet.

The full dose intervention group will also receive a 10 week program consisting of the same weekly support messages and the magnetised parent resource booklet provided to the low dose group, plus the development of school based “lunchbox nutrition guidelines”, access to classroom curriculum resources and provision of a water bottle and ice brick to students.

The weekly support messages (one message per week for 10 weeks) have been developed by public health nutritionists for the SWAP IT program and are consistent across the two intervention groups. 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 includes short word messages, relevant pictures, links to videos and the project website and an email address to request further information. App analytics will be obtained to monitor message reach.

The magnetised parent resource has been designed by public health nutritionists for the SWAP IT program and will be provided to parents in both intervention groups. This resource aims to facilitate the packing of a healthy lunchbox through the provision of tips and photos which can be accessed by parents at the time of packing.

Schools allocated to the full dose will be provided with a lunchbox nutrition guidelines template, designed by public health nutritionists for the SWAP IT program and based on the SWAP IT program principles of packing a lunchbox full of everyday foods and swapping what is packed from sometimes to everyday foods. These schools will be supported by an experienced Public Health Nutritionist to modify these, ensuring applicability to their school community. Endorsement of the guidelines will be promoted to the school community utilising the authority of the school Principal, to communicate school expectations and normalise healthy lunchboxes. A copy of the school’s lunchbox nutrition guidelines will be forwarded to all families through the school’s usual communication channels.
Intervention code [1] 315523 0
Prevention
Intervention code [2] 315524 0
Lifestyle
Intervention code [3] 315525 0
Behaviour
Comparator / control treatment
Full dose - app plus school guidelines, classroom curriculum and physical resource.
Control group
Active

Outcomes
Primary outcome [1] 321339 0
The mean kilojoule (kJ) content of discretionary foods and drinks packed in children’s lunchboxes. 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] 321339 0
Baseline and approximately 2 months post baseline.
Secondary outcome [1] 374699 0
Mean total kilojoules (kJ) content of foods and drinks packed in lunchboxes. 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 [1] 374699 0
Baseline and approximately 2 months post baseline.
Secondary outcome [2] 374700 0
Percent energy from discretionary foods and drinks packed in children’s lunchboxes. 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 [2] 374700 0
Baseline and approximately 2 months post baseline.
Secondary outcome [3] 374701 0
Mean cost of lunchbox contents, measured in dollars and cents. 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 [3] 374701 0
Baseline and approximately 2 months post baseline.

Eligibility
Key inclusion criteria
Department of Education (DoE) schools within the Hunter New England Local Health District, Central Coast Local Health District and Mid North Coast Local Health District who cater for primary school aged children and were control schools from the linked study will be invited to participate. Schools must currently be using the school communication application.

All students at eligible schools were invited to participate during the linked trial. Only students with parental consent from the previous trial will participate.
Minimum age
4 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Schools with secondary students only, schools catering exclusively for children requiring specialist care, schools who have already participated in the SWAP IT program and/or schools already involved in other nutrition or physical activity trials 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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
30/09/2019
Actual
23/09/2019
Date of last participant enrolment
Anticipated
Actual
27/09/2019
Date of last data collection
Anticipated
18/12/2019
Actual
Sample size
Target
1000
Accrual to date
Final
1000
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 303768 0
Charities/Societies/Foundations
Name [1] 303768 0
nib Foundation
Country [1] 303768 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
CALLAGHAN
NSW 2308
Country
Australia
Secondary sponsor category [1] 303889 0
Government body
Name [1] 303889 0
Hunter New England Population Health
Address [1] 303889 0
Locked Bag 10
WALLSEND
NSW 2287
Country [1] 303889 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304289 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 304289 0
Ethics committee country [1] 304289 0
Australia
Date submitted for ethics approval [1] 304289 0
05/09/2019
Approval date [1] 304289 0
17/09/2019
Ethics approval number [1] 304289 0
2019/ETH12353

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

Contacts
Principal investigator
Name 96410 0
A/Prof Luke Wolfenden
Address 96410 0
Hunter New England Population Health
Locked Bag 10
WALLSEND
NSW 2287
Country 96410 0
Australia
Phone 96410 0
+61 2 4924 6499
Fax 96410 0
Email 96410 0
Luke.Wolfdenden@health.nsw.gov.au
Contact person for public queries
Name 96411 0
Rachel Sutherland
Address 96411 0
Hunter New England Population Health
Locked Bag 10
WALLSEND
NSW 2287
Country 96411 0
Australia
Phone 96411 0
+61 2 4924 6499
Fax 96411 0
Email 96411 0
Rachel.Sutherland@health.nsw.gov.au
Contact person for scientific queries
Name 96412 0
Rachel Sutherland
Address 96412 0
Hunter New England Population Health
Locked Bag 10
WALLSEND
NSW 2287
Country 96412 0
Australia
Phone 96412 0
+61 2 4924 6499
Fax 96412 0
Email 96412 0
Rachel.Sutherland@health.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?

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.