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Trial registered on ANZCTR


Registration number
ACTRN12616001228471
Ethics application status
Approved
Date submitted
24/08/2016
Date registered
5/09/2016
Date last updated
15/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
School-based interventions to improve the lunchbox contents and physical activity levels of children.
Scientific title
The efficacy of school-based intervention, relative to comparison, in improving child physical activity and the nutritional quality of foods packed for children to consume at school.
Secondary ID [1] 290009 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nutrition 300023 0
Physical Activity 300024 0
Condition category
Condition code
Public Health 299915 299915 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To increase the efficiency of two separate interventions, a randomised factorial design will be utilised, that sees schools randomly allocated and provided with either; i) a lunchbox only intervention; ii) a physical activity only intervention; iii) a combined lunchbox/ physical activity intervention or iv) control. A brief description of the interventions are described below;

Lunchbox intervention (Group 1)
The lunchbox intervention aims to improve the contents of children’s lunchboxes by supporting parents/carers to swap what is packed from non-core foods and drinks to core foods and drinks. The intervention seeks to address the barriers faced by parents to packing a healthy lunchbox (time/convenience, cost, child preference, food safety and knowledge). The 10 week intervention will utilise an existing school mobile application to communicate lunchbox messages to parents/carers along with the dissemination of physical tools and resource to address barriers and support change. Due to school holidays, the intervention will not begin until the start of Term 1 2017.
The intervention will include the following:

Information to parents – Using the existing mobile communication application 10 x short messages to parents (one per week) will be “pushed” to parents. These messages will address the identified barriers to packing a healthy lunchbox. Content includes a the key message of the week for example “budget friendly lunchbox ideas”, relevant picture, a 50 word message, a link to a video (only in selected pushes), link to the project website (http://www.goodforkids.nsw.gov.au/), an email address to request further information and the opportunity to share the push notification via Facebook and Instagram.
Resources- children at each school will receive the following resources which are aimed to facilitate the packing of healthy lunchboxes: an ice brick, a water bottle, a shopping list, a shopping bag, a magnetised parent resource booklet and lunchbox stickers.

Static Display- schools will be asked to display 10 x pictorial posters (one per week) in school offices displaying a healthy lunchbox which include tips to address the known barriers.

Physical activity intervention (Group 2)
The physical activity intervention is a 3 term intervention (approx. 9 month) and aims to assess the effectiveness of implementation of a mandatory NSW Department of Education physical activity policy (Sport and Physical Activity Policy) on student’s physical activity levels. The policy requires that students from Kindergarten to Year 10 participate in a minimum of 150 minutes of planned moderate with some vigorous physical activity across the school week. Planned physical activity includes time spent in PE, sport and other structured activities that is inclusive of all children and is part of their regular programming and planning. To support schools implementation of this policy they will be offered;
1. 1 x day (5hrs) face to face training delivered by trained PE teachers for primary school stage coordinators to help with the scheduling of PE, sport and other physical activity;
2. 1 x 2hr face to face professional development for all teachers to increase the quality and activity of PE and sport;
3. Resources including example schedules that meet the 150minute policy, manuals that support the teaching of PE and pedometers for teachers to use with students to increase activity in PE and sport;
4. On-going support via telephone and email with trained PE teachers to support the implementation of the policy.
If schools in Group 1 or Control are meeting the policy this will be captured during baseline data collection. They will be advised to continue on with usual practice.

Schools in the combined lunchbox/physical activity intervention (Group 3) will receive both interventions concurrently for the first ten weeks, and then the physical activity intervention for the remainder of the 9 months.

Schools will be randomly observed by project staff throughout the intervention period which will allow intervention strategies to be monitored i.e. lunchbox static displays and delivery of the NSW PA policy.
Intervention code [1] 295718 0
Prevention
Intervention code [2] 295747 0
Lifestyle
Comparator / control treatment
Usual practice (no intervention) – consisting of usual school practices towards healthy eating or physical activity in the school community, which may or may not include professional development opportunities for teachers, resources, and/or school policies. They will be offered the intervention after the 9 month follow up assessments have occurred.
Control group
Active

Outcomes
Primary outcome [1] 299397 0
The mean kilojoule (kJ) content of children’s lunchboxes of parents who use a school mobile application. KJ content of lunchboxes will be assessed by taking photographs of lunchboxes and assessing against a modified validated School Food Checklist.
Timepoint [1] 299397 0
Baseline, immediately post intervention i.e. at the completion of the 10 week intervention and 9 months post baseline
Primary outcome [2] 299398 0
Students’ mean physical activity counts per minute. Total minutes of physical activity will be measured objectively using an accelerometer, worn by students in grade K-6 from all schools for 5 consecutive days during school hours.
Timepoint [2] 299398 0
Baseline and 9 months post-baseline
Primary outcome [3] 299399 0
BMI (height, weight) will be collected at baseline and long term follow up from consenting students in years 4, 5 and 6 in 2017.
Timepoint [3] 299399 0
Baseline and 9 months post-baseline
Secondary outcome [1] 327075 0
The mean proportion of everyday foods in a child’s lunchbox of parents who use the school mobile application. Everyday food refers to food and drink items that are part of the core food groups as determined by the Australian Dietary Guidelines and Australian Guide to Healthy Eating. Each food item will be assessed as everyday or sometimes according to a modified version of the School Food Checklist
Timepoint [1] 327075 0
Baseline, immediately post 10-week intervention and 9 months post baseline
Secondary outcome [2] 327076 0
The proportion of primary school teachers who report the provision of 150 mins of planned physical activity to their class as required by the policy measured via teacher questionnaire. Teachers will fill out a questionnaire, which was developed for the purpose of this study, each day for one school week stating the amount of physical activity that was provided to their class. Observations conducted throughout the baseline data collection will be used to validate teacher questionnaire.
Timepoint [2] 327076 0
Baseline, mid-intervention (approximately 6 months following baseline) and 9 months post baseline
Secondary outcome [3] 327077 0
Objectively-measured sedentary time (students) using an accelerometer worn by students in grade K-6 from all schools for one school week (i.e. 5 consecutive days) during school hours.
Timepoint [3] 327077 0
Baseline and 9 months post-baseline
Secondary outcome [4] 327078 0
Student’s waist circumference for year 4, 5 & 6 students measured using flexible inelastic tape at the narrowest point around the waist (cm)
Timepoint [4] 327078 0
Baseline and 9 months post-baseline
Secondary outcome [5] 327079 0
Student quality of life measured by PedsQL tool for students in years 4, 5, & 6.
Timepoint [5] 327079 0
Baseline and 9 months post-baseline
Secondary outcome [6] 327080 0
Student pain using an adaptation of the Young Spine Questionnaire for students in years 4, 5 & 6.
Timepoint [6] 327080 0
Baseline and 9 months post-baseline

Eligibility
Key inclusion criteria
Catholic primary schools within the Hunter New England Local Health District of NSW will be invited to participate. Schools must currently be using the school mobile Application. 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 (central schools), catering exclusively for children requiring specialist care, and/or schools already involved in a physical activity trial will be ineligible. All students are eligible to participate in the trial.

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)
Following baseline data collection, schools will be randomised in a 3:1 ratio to either an intervention or control group via a central randomisation process by computer. Block randomisation will be employed to ensure group allocation is approximately equal. Data collectors will be blind to group allocation. Due to the nature of the intervention school staff will be aware of their group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An independent statistician will use a computerised random number function to randomise schools in a 1:3 ratio
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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] 294377 0
Government body
Name [1] 294377 0
Hunter New England Population Health
Address [1] 294377 0
Locked Bag 10
Wallsend NSW 2287
Country [1] 294377 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] 293222 0
None
Name [1] 293222 0
Nil
Address [1] 293222 0
Nil
Country [1] 293222 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295801 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 295801 0
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 295801 0
Australia
Date submitted for ethics approval [1] 295801 0
15/08/2016
Approval date [1] 295801 0
25/08/2016
Ethics approval number [1] 295801 0
06/07/26/4.04
Ethics committee name [2] 296596 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 296596 0
University Drive, Callaghan NSW 2308
Ethics committee country [2] 296596 0
Australia
Date submitted for ethics approval [2] 296596 0
Approval date [2] 296596 0
27/01/2009
Ethics approval number [2] 296596 0
H-2008-0343
Ethics committee name [3] 296597 0
Catholic Schools Office: Diocese of Maitland-Newcastle
Ethics committee address [3] 296597 0
841 Hunter Street, Newcastle West NSW 2302
Ethics committee country [3] 296597 0
Australia
Date submitted for ethics approval [3] 296597 0
Approval date [3] 296597 0
09/11/2009
Ethics approval number [3] 296597 0

Summary
Brief summary
The aim of this factorial randomised control trial is evaluate the efficacy of a lunchbox intervention, a physical activity intervention and a combined lunchbox/ physical activity intervention on child physical activity levels and the nutritional content of student lunchboxes.. Twelve primary schools in the Hunter region will be randomly allocated to one of 3 intervention arms or a control group. The final trial endpoint is 9 months.
Trial website
Trial related presentations / publications
Public notes
To increase the efficiency in the delivery and assessment of the efficacy of two public health interventions a factorial design has been utilised to enable simultaneous assessment of both. However the outcomes for each intervention (lunchbox or physical activity) are planned to be published separately

Contacts
Principal investigator
Name 68526 0
Dr Nicole Nathan
Address 68526 0
Hunter New England Population Health
Longworth Avenue
WALLSEND, NSW 2287
Country 68526 0
Australia
Phone 68526 0
+ 61 2 49246257
Fax 68526 0
Email 68526 0
nicole.nathan@hnehealth.nsw.gov.au
Contact person for public queries
Name 68527 0
Dr Nicole Nathan
Address 68527 0
Hunter New England Population Health
Longworth Avenue
WALLSEND, NSW 2287
Country 68527 0
Australia
Phone 68527 0
+ 61 2 49246257
Fax 68527 0
Email 68527 0
nicole.nathan@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 68528 0
Dr Nicole Nathan
Address 68528 0
Hunter New England Population Health
Longworth Avenue
WALLSEND, NSW 2287
Country 68528 0
Australia
Phone 68528 0
+ 61 2 49246257
Fax 68528 0
Email 68528 0
nicole.nathan@hnehealth.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary