Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001363178
Ethics application status
Approved
Date submitted
18/09/2019
Date registered
4/10/2019
Date last updated
4/10/2019
Date data sharing statement initially provided
4/10/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can improvements in the nutrition quality of lunchboxes, following an app-based intervention, be maintained with or without support.
Scientific title
A cluster randomised trial to evaluate the efficacy of booster messages in maintaining improvements in the nutritional quality of lunchboxes.
Secondary ID [1] 299145 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). This current trial is a follow-up study, from the parent study, utilising the intervention schools.

Health condition
Health condition(s) or problem(s) studied:
Nutrition 314466 0
Child obesity 314467 0
Condition category
Condition code
Public Health 312799 312799 0 0
Health promotion/education
Diet and Nutrition 312800 312800 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 booster messages in maintaining improvements in the nutrition quality of primary school lunchboxes.

All schools have received the app-based intervention which aimed to improve the contents of primary school aged 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 sought to address the barriers faced by parents to packing a healthy lunchbox (time/convenience, cost, child preference, food safety and knowledge). The fifteen week program delivered to schools during 2019, consisted of:
1. Development and dissemination of lunchbox nutrition guidelines
2. Weekly support messages (via the school communication app)
3. Resources for parents (booklet, water bottle and ice brick)
4. Resources for schools (classroom flipcharts and lesson plans)

Following the post baseline data collection for the trial listed above, schools will be randomly allocated to an intervention group or control group.

The intervention group will receive two booster messages, delivered via the school communication app, SkoolBag. The first message willl be delivered approximately six weeks post the app-based intervention and the second will be delivered one month later. The booster messages have been developed by public health nutritionists for the SWAP IT program. These messages address the identified barriers to packing a healthy lunchbox and act as prompts and cues to maintain the packing of everyday foods. Content, based on barriers identified by parents and engagement with original weekly support messages, may include short word messages, relevant pictures, links to videos and the project website, and an email address to request further information.

Intervention schools may also receive professional development, policies and/or resources similarly to schols allocated to the "Usual Practice" control condition.
Intervention code [1] 315590 0
Prevention
Intervention code [2] 315591 0
Lifestyle
Intervention code [3] 315592 0
Behaviour
Comparator / control treatment
Usual practice (no program) – schools will have already received the app based intervention but will receive no further messages. Schools may receive support to implement 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 control group will participate in data collection only.
Control group
Active

Outcomes
Primary outcome [1] 321418 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] 321418 0
Baseline and immediately post intervention (approximately 3 months post baseline).
Secondary outcome [1] 374915 0
Mean total kilojoule (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] 374915 0
Baseline and immediately post intervention (approximately 3 months post baseline).
Secondary outcome [2] 374916 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] 374916 0
Baseline and immediately post intervention (approximately 3 months post baseline).
Secondary outcome [3] 374917 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] 374917 0
Baseline and immediately post intervention (approximately 3 months post baseline).

Eligibility
Key inclusion criteria
Department of Education (DoE) schools within the Hunter New England, Mid North Coast or Central Coast Local Health District, who cater for primary school aged children, are currently using the school communication application and have implemented the app-based lunchbox program will be invited to participate.

All students at eligible schools were invited to participate during the linked trial. Only students with parental consent from the linked 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, 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
Recruiting
Date of first participant enrolment
Anticipated
Actual
23/09/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
900
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 303684 0
Charities/Societies/Foundations
Name [1] 303684 0
nib Foundation
Country [1] 303684 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 303789 0
Government body
Name [1] 303789 0
Hunter New England Population Health
Address [1] 303789 0
Locked Bag 10
Wallsend NSW 2287
Country [1] 303789 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304209 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 304209 0
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 304209 0
Australia
Date submitted for ethics approval [1] 304209 0
Approval date [1] 304209 0
17/09/2019
Ethics approval number [1] 304209 0

Summary
Brief summary
The aim of this randomised control trial is to determine if improvements in the nutrition quality of lunchboxes following an app based intervention can be maintained with or without additional support. Schools who have received the app based intervention will be randomised to either receive two additional booster messages via the school communication app, over a one month period or to the control group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96146 0
A/Prof Luke Wolfenden
Address 96146 0
Hunter New England Population Health
Locked Bag 10
Wallsend NSW 2287
Country 96146 0
Australia
Phone 96146 0
+61 2 4924 6499
Fax 96146 0
Email 96146 0
[email protected]
Contact person for public queries
Name 96147 0
Dr Rachel Sutherland
Address 96147 0
Hunter New England Population Health
Locked Bag 10
Wallsend NSW 2287
Country 96147 0
Australia
Phone 96147 0
+61 2 4924 6499
Fax 96147 0
Email 96147 0
[email protected]
Contact person for scientific queries
Name 96148 0
Dr Rachel Sutherland
Address 96148 0
Hunter New England Population Health
Locked Bag 10
Wallsend NSW 2287
Country 96148 0
Australia
Phone 96148 0
+61 2 4924 6499
Fax 96148 0
Email 96148 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


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.