Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001918213
Ethics application status
Approved
Date submitted
19/11/2018
Date registered
26/11/2018
Date last updated
13/11/2019
Date data sharing statement initially provided
26/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Can an app-based intervention targeting parents, with or without the development of school guidelines, 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 school lunchbox guidelines in improving the lunchbox contents of primary school aged children.
Secondary ID [1] 296625 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nutrition 310441 0
Child obesity 310442 0
Condition category
Condition code
Public Health 309156 309156 0 0
Health promotion/education
Diet and Nutrition 309157 309157 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomised factorial design will be utilised to test the efficacy of an app only and app plus school guidelines 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 either one of two intervention arms or a waitlist control group. The program will run for approximately 15 weeks.

The app only (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 app plus school guidelines (medium dose) intervention group will receive a 15 week program consisting of the weekly support messages and the magnetised parent resource booklet, plus the development of school based “lunchbox nutrition guidelines. An experienced public health nutritionist will work with schools to develop lunchbox nutrition guidelines. Schools will be provided with a guideline template, based on the SWAP IT program principles, and will be supported to modify to ensure applicability to their school community. 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. Following the development of the guidelines, weekly support messages will be delivered to parents using an existing school communication application. Parents will also receive a magnetised parent resource booklet.

The weekly support messages 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 may include short word messages, relevant pictures, links to videos and project website and an email address to request further information.

The magnetised parent resources has been designed by public health nutritionists for the SWAP IT program and will provided to parents in both intervention groups. This resource aims to facilitate the packing of healthy lunchbox through the provision of tips and photos which can be accessed by parents at time of packing.
Intervention code [1] 312932 0
Prevention
Intervention code [2] 312933 0
Lifestyle
Intervention code [3] 312934 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 completion of the study.
Control group
Active

Outcomes
Primary outcome [1] 308135 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] 308135 0
Timepoint: Baseline and immediately post intervention (approximately 6 months post baseline).
Secondary outcome [1] 354046 0
The mean kilojoule (kJ) content of discretionary foods and drinks consumed from children’s lunchboxes. 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] 354046 0
Timepoint: Baseline and immediately post intervention (approximately 6 months post baseline).
Secondary outcome [2] 354047 0
Mean total kilojoules (kJ) content of foods 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 [2] 354047 0
Timepoint: Baseline and immediately post intervention (approximately 6 months post baseline).
Secondary outcome [3] 354048 0
Mean total kilojoules (kJ) content of foods consumed from children’s lunchboxes. 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 [3] 354048 0
Baseline and immediately post intervention (approximately 6 months post baseline).
Secondary outcome [4] 354049 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 [4] 354049 0
Baseline and immediately post intervention (approximately 6 months post baseline).
Secondary outcome [5] 354050 0
Percent energy from discretionary foods and drinks consumed from children’s lunchboxes. 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 [5] 354050 0
Baseline and immediately post intervention (approximately 6 months post baseline).
Secondary outcome [6] 354052 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 [6] 354052 0
Baseline and immediately post intervention (approximately 6 months post baseline).

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

All students at eligible schools will be invited to 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, 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)
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
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
3600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 301202 0
Charities/Societies/Foundations
Name [1] 301202 0
nib Foundation
Country [1] 301202 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 300837 0
Government body
Name [1] 300837 0
Hunter New England Population Health
Address [1] 300837 0
Locked Bag 10
Wallsend NSW 2287
Country [1] 300837 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301943 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 301943 0
Ethics committee country [1] 301943 0
Australia
Date submitted for ethics approval [1] 301943 0
Approval date [1] 301943 0
23/08/2018
Ethics approval number [1] 301943 0

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

Contacts
Principal investigator
Name 88646 0
A/Prof Luke Wolfenden
Address 88646 0
Hunter New England Population Health
Locked Bag 10
Wallsend, NSW Australia 2287
Country 88646 0
Australia
Phone 88646 0
+61 2 4924 6499
Fax 88646 0
Email 88646 0
Luke.Wolfenden@hnehealth.nsw.gov.au
Contact person for public queries
Name 88647 0
Rachel Sutherland
Address 88647 0
Hunter New England Population Health
Locked Bag 10
Wallsend, NSW 2287
Country 88647 0
Australia
Phone 88647 0
+61 2 4924 6499
Fax 88647 0
Email 88647 0
Rachel.Sutherland@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 88648 0
Rachel Sutherland
Address 88648 0
Hunter New England Population Health
Locked Bag 10
Wallsend, NSW 2287
Country 88648 0
Australia
Phone 88648 0
+61 2 4924 6499
Fax 88648 0
Email 88648 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?

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.