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Trial registered on ANZCTR


Registration number
ACTRN12618000133235
Ethics application status
Approved
Date submitted
25/01/2018
Date registered
30/01/2018
Date last updated
6/09/2019
Date data sharing statement initially provided
6/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
An app-based intervention to improve the packing of healthy food in children’s lunchboxes in childcare.
Scientific title
A randomised controlled trial of an app-based intervention to improve the nutrition profile of foods packed in lunchboxes of young children (aged 3-6 years) attending early childhood education and care centres.
Secondary ID [1] 293883 0
None
Universal Trial Number (UTN)
U1111-1208-4617
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood overweight and obesity 306347 0
Condition category
Condition code
Diet and Nutrition 305436 305436 0 0
Obesity
Public Health 305437 305437 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An intervention to decrease the packing of non-core foods (i.e. energy dense, nutrient poor foods) in lunchboxes will be delivered to eligible children attending early education and care long day care centres.
The intervention will primarily target parents of children aged 3-6 years attending a selected sample of early education and care services (Long Day Care and Preschools services). Strategy selection will be guided by the Behaviour Change Wheel (BCW) and primarily be delivered via a communication app that is currently used by childcare services to provide information to parents. The intervention components will be delivered over a 16 week period.

The components of the intervention are as below:
1. Provision of regular prompts and reminders to parents
Regular messages (developed by Public Health Nutritionists) sent via push notifications will be provided to parents. Messages addressing parent reported barriers to packing healthier food in lunchboxes will be delivered via push notifications for 10 weeks (one per week) to support parents with packing healthier lunchboxes for the child . The push notifications will consist of a brief written message designed to influence parent behaviour related to packing of lunchboxes. Message content will be enhanced by the use of relevant graphics, text and/or embedded video links. Specifically each message will encourage parents to swap non-core foods for core foods in the lunchbox as well as provide advice, information or ideas for overcoming an identified barrier to packing healthy lunchboxes. Implementation fidelity (ie delivery of messages) will be ascertained by accessing app analytics, as well as measure parent access of the messages.

2. Providing suggestions on types of food to pack in lunchboxes
To address a key barrier to packing healthier lunchboxes (i.e. parents not knowing what particular foods to pack), parents will be given access, and encouraged to use, a list of recommended and not recommended foods for their child lunchbox. The list will be referred to regularly as part of the weekly push messages as well as be statically accessible content on the app

3. Childcare service lunchbox guidelines
Nominated supervisors will receive support to ensure consistency between any current service lunchbox guidelines and the lunchbox recommendations within the app. The guidelines will outline the recommended foods as well as highlight non -core foods not recommended for inclusion in lunchboxes. Nominated supervisors will be asked to communicate any changes to existing guidelines to educators and parents via the app and/or newsletters or verbally.


4. Childcare services endorsement of the intervention
To support use of the app by parents and ensure consistency in nutrition message promoted, research staff will meet with the service Nominated supervisor of each intervention service to orientate them to the intervention, secure managerial endorsement and seek a commitment from service managers to communicate the initiative to Educators and parents.
Nominated Supervisors will also distribute a printed resource pack to Educators containing the all the intervention content available via the app, including the push notification messages and the decision making tool containing the list of recommended and non-recommended foods for the lunchbox.

Nominated supervisors will also be asked to communicate endorsement of the initiative to parents via the app and/ or other preferred communication method. They will also be asked to send a second parent message or other communication item mid-way through the intervention will the purpose of encouraging continued participation and providing non-contingent praise and positive feedback. Nominated supervisors will be asked to complete a record of implementation in order to assess compliance with these requests.
Intervention code [1] 300146 0
Prevention
Intervention code [2] 300173 0
Lifestyle
Comparator / control treatment
The control group will not receive any support from the research team and will continue to access the app without additional lunchbox content. Control services will receive support to improve packing of lunchboxes after the intervention period,
Control group
Active

Outcomes
Primary outcome [1] 304565 0
Primary Outcome 1: Mean energy (kJ) provided by non-core food and drinks packed in childcare lunchboxes.

Lunchbox contents will be measured via photos and weighing of food and drinks prior to consumption by a research assistant. Data will be recorded using a standardised form developed by the team. Weighing is considered the gold standard for measuring food portion size. Energy provided by non-core foods will be calculated using nutrition analysis software.
Timepoint [1] 304565 0
At baseline and at the end of the intervention period
Primary outcome [2] 304566 0
Primary Outcome 2: Mean saturated fat (g) provided by all food and drinks packed in childcare lunchboxes.

Lunchbox contents will be measured via photos and weighing food and drinks prior to consumption. Data will be recorded using a standardised form developed by the team. Weighing is considered the gold standard for measuring food portion size. Saturated fat content will be calculated using nutrition analysis software
Timepoint [2] 304566 0
At baseline and at the end of the intervention period
Primary outcome [3] 304567 0
Primary Outcome 3: Mean sugar (g) provided by all food and drinks packed in childcare lunchboxes.
Lunchbox contents will be measured via photos and weighing food and drinks prior to consumption. Data will be recorded using a standardised form developed by the team. Weighing is considered the gold standard for measuring food portion size. Sugar content will be calculated using nutrition analysis software.
Timepoint [3] 304567 0
At baseline and at the end of the intervention period
Secondary outcome [1] 342425 0
Primary Outcome 4: .Mean sodium (mg) provided by all food and drinks packed in childcare lunchboxes.
Lunchbox contents will be measured via photos and weighing food and drinks prior to consumption. Data will be recorded using a standardised form developed by the team. Weighing is considered the gold standard for measuring food portion size. Sodium content will be calculated using nutrition analysis software.
Timepoint [1] 342425 0
At baseline and at the end of the intervention period
Secondary outcome [2] 342426 0
Secondary Outcome 1: Mean energy (kJ) provided by non-core food and drinks consumed by children from childcare lunchboxes.
Lunchbox contents consumed will be measured by comparing and food and drinks weights, pre and post- child consumption. Data will be recorded using a standardised form developed by the team. Weighing pre and post is considered the gold standard for measuring food consumption. Energy consumed from non-core foods will be calculated using nutrition analysis software.
Timepoint [2] 342426 0
At baseline and at the end of the intervention period
Secondary outcome [3] 342427 0
Secondary Outcome 2: Mean saturated fat provided by all food and drinks consumed by children from childcare lunchboxes.

Lunchbox contents consumed will be measured via comparison of photos and food and drinks weights, pre and post to consumption. Data will be recorded using a standardised form developed by the team. Weighing pre and post is considered the gold standard for measuring food consumption. Saturated fat content consumed will be calculated using nutrition analysis software
Timepoint [3] 342427 0
At baseline and at the end of the intervention period
Secondary outcome [4] 342428 0
Secondary outcome 3: Mean sugar provided by all food and drinks consumed by children from childcare lunchboxes.
Lunchbox contents consumed will be measured via comparison of photos and food and drinks weights, pre and post to consumption. Data will be recorded using a standardised form developed by the team. Weighing pre and post is considered the gold standard for measuring food consumption. Sugars content consumed will be calculated using nutrition analysis software
Timepoint [4] 342428 0
At baseline and at the end of the intervention period
Secondary outcome [5] 342429 0
Secondary Outcome 4: Mean sodium provided by all food and drinks consumed by children from childcare lunchboxes.
Lunchbox contents consumed will be measured via comparison of photos and food and drinks weights, pre and post to consumption. Data will be recorded using a standardised form developed by the team. Weighing pre and post is considered the gold standard for measuring food consumption. Sodium content consumed will be calculated using nutrition analysis software.
Timepoint [5] 342429 0
At baseline and at the end of the intervention period
Secondary outcome [6] 342430 0
Secondary Outcome 5: Child usual consumption of non-core foods
Overall child food group consumption will be measured via an online parent completed food frequency questionnaire, based on an adapted version of a valid and reliable tool, the Short Food Survey
Timepoint [6] 342430 0
At baseline and at the end of the intervention period

Eligibility
Key inclusion criteria
Early Education and Care Services (Long Day Care Services and Preschools):
For a service to be eligible, it will be located within the Hunter New England region of NSW Australia, cater for children 3-6 years of age, be a “lunchbox service” (ie requires parents to provide all food), be open for at least 8 hours per day, be using or willing to commence using the parent communication app used to deliver the intervention.

Parents:
For parents to be eligible they must have a child aged 3-6 years attending the “lunchbox” service on the days of designated data collection, have access or be willing to access the app.

Children:
For children within the service to be eligible to participate they will be aged 3-6 years, have parental consent and attend care during any of the days of designated data collection.
Minimum age
3 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Early Education and Care Services (Long Day Care Services and Preschools):
Services will be excluded if they are participating in any trial related to improving child nutrition, are a Department and Education community run service or cater exclusively for children with special needs.

Parents:
Parents will be excluded if are participating in any trial related to improving child nutrition.

Children:
Children will be excluded from the trial if they have special dietary requirements or allergies that would necessitate specialised tailoring of their diet such that it may be adversely affected by the intervention.

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)
A list of services currently utilising the app or not utlising any type of app will be sourced from data collected as part of previous surveys and verified with the app providers. The services and parent users of the app will be invited to provide verbal and written consent. Services will be mailed an information statement and consent form approximately one week prior to a follow up phone call assessing service eligibility and inviting the service to participate in the study. Random allocation of services to groups will occur following baseline data collection. Allocation to groups will be conducted by an independent statistician, at a centralised location.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Consenting childcare services will be randomly allocated to an intervention or control group in a 1:1 ratio via block randomisation using a random number function in SAS statistical software following baseline data collection. Allocation of services will be undertaken by a statistician who will otherwise have no involvement in the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A regression model (linear or logistic depending on outcome), adjusted for baseline values of the primary trial outcome and clustering by childcare services will be used to examine changes in the outcomes.
We will recruit 390 children from 18 childcare services. This will allow us to detect a mean difference of approximately 140kJ in the primary outcome, with an alpha of 0.01, and an estimated ICC of 0.1, with 80% power and a standard deviation of 200. An additional outcome analysis will be conducted whereby only parents who have downloaded the app will be included.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/02/2018
Actual
12/03/2018
Date of last participant enrolment
Anticipated
1/06/2018
Actual
5/06/2018
Date of last data collection
Anticipated
30/11/2018
Actual
1/02/2019
Sample size
Target
390
Accrual to date
Final
397
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 298506 0
Government body
Name [1] 298506 0
Hunter New England Local Health District Population Health
Country [1] 298506 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Local Health District Population Health
Address
Longworth Avenue, Wallsend, NSW 2287
Country
Australia
Secondary sponsor category [1] 297648 0
None
Name [1] 297648 0
Address [1] 297648 0
Country [1] 297648 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299486 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 299486 0
Ethics committee country [1] 299486 0
Australia
Date submitted for ethics approval [1] 299486 0
16/01/2017
Approval date [1] 299486 0
20/02/2018
Ethics approval number [1] 299486 0

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

Contacts
Principal investigator
Name 80574 0
Dr Meghan Finch
Address 80574 0
Hunter New England Local Health District Population Health
c/o Booth Building, Longworth Avenue
Wallsend 2287 NSW
Country 80574 0
Australia
Phone 80574 0
+612 4924 6131
Fax 80574 0
+61 2 4924 6215
Email 80574 0
Meghan.Finch@hnehealth.nsw.gov.au
Contact person for public queries
Name 80575 0
Meghan Finch
Address 80575 0
Hunter New England Local Health District Population Health
c/o Booth Building, Longworth Avenue
Wallsend 2287 NSW
Country 80575 0
Australia
Phone 80575 0
+612 4924 6131
Fax 80575 0
+61 2 4924 6215
Email 80575 0
Meghan.Finch@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 80576 0
Meghan Finch
Address 80576 0
Hunter New England Local Health District Population Health
c/o Booth Building, Longworth Avenue
Wallsend 2287 NSW
Country 80576 0
Australia
Phone 80576 0
+612 4924 6131
Fax 80576 0
+61 2 4924 6215
Email 80576 0
Meghan.Finch@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
No planned sharing of data, however de-identified data may be made available on request.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4575Study protocol1. Pond, N, Finch, M, Sutherland R, Wolfenden L, Nathan N, Kingsland M, Grady A, Gillham K, Herrmann V, Yoong S.. A cluster randomised controlled trial of an m-health intervention in centre based childcare services to reduce the packing of discretionary foods in children’s lunchboxes: Study protocol for the “SWAP IT Childcare” trial. BMJ Open. 2019 Jun 1;9(5):e026829. doi: 10.1136/bmjopen-2018-026829https://bmjopen.bmj.com/content/9/5/e026829.long  374379-(Uploaded-05-09-2019-14-08-40)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCluster randomised controlled trial of an m-health intervention in centre-based childcare services to reduce the packing of discretionary foods in children's lunchboxes: Study protocol for the 'SWAP IT Childcare' trial.2019https://dx.doi.org/10.1136/bmjopen-2018-026829
N.B. These documents automatically identified may not have been verified by the study sponsor.