Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000878774
Ethics application status
Approved
Date submitted
14/06/2022
Date registered
21/06/2022
Date last updated
29/05/2023
Date data sharing statement initially provided
21/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
'Adventure & Veg' - the effectiveness of a parental text message and social media program on primary-school aged children's physical activity and vegetable eating behaviours; a randomised, controlled trial (pilot study).
Scientific title
'Adventure & Veg' - the effectiveness of a parental text message and social media program on primary-school aged children's physical activity and vegetable eating behaviours; a randomised controlled trial (pilot study).
Secondary ID [1] 307344 0
Nil known
Universal Trial Number (UTN)
-
Trial acronym
-
Linked study record
-

Health condition
Health condition(s) or problem(s) studied:
Childhood obesity 326633 0
Physical inactivity 326634 0
Poor diet 326635 0
Condition category
Condition code
Diet and Nutrition 323879 323879 0 0
Obesity
Public Health 323880 323880 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Parents or carers with primary school-aged children will receive 8 weeks of daily text messages (5 messages each week) on tips for healthy lifestyle habits with a focus on physical activity and vegetable intake promotion. The text messages will be developed with advice from experts in physical activity, nutrition and health promotion. The messages will be designed using Michie et al’s COM-B system from the Behaviour Change Wheel, with the aim of increasing families’ capability, opportunity and motivation to support healthy eating and physical activity behaviours. Additionally the behaviour change techniques that we will use in the text messages will be based on the Behaviour Change Technique Taxonomy. A technology platform for the automation of text messages has been developed and tested using Burst SMS. Participants can stop receiving messages at any time by texting ‘STOP’.

Examples of text messages are as follows:

Fussy veggie eaters? Keep trying and don't give up! Some kids need to try a new food several times before they accept it and decide they like it.

Turn screen time into green time. Time in nature can boost everyone's mood. Why not plan a walk together this week?

For better quality sleep, make everyone's bedroom screen free. Keep TVs out of children's rooms and have a separate place where devices 'sleep' overnight.

Parents or carers will also have access to a closed Facebook group with weekly local outdoor activity ideas across the four local government areas of the Illawarra Shoalhaven Local Health District (Wollongong, Shellharbour, Kiama and Shoalhaven). As with the text messages, the Facebook posts will employ behaviour change techniques from the Behaviour Change Technique Taxonomy.

Each week will have a different theme with four posts per week (one from each of the local government areas). The activity ideas are all self-directed, free of charge and fall in to the following categories:
i. Bushwalking
ii. Bike paths
iii. Playgrounds
iv. Waterfalls
v. Coastal walks
vi. Skate parks, BMX & pump tracks
vii. Ocean rock pools
viii. Picnic – Gardens & National Parks


The Friday text message will nudge participants to look at the Facebook page e.g.

Where will your weekend take you? Swing, slide, spin, climb! There are 100s of local play spaces and parks. Check out our favourites: {insert Facebook link}

Participants will be able to post messages and chat with other program participants on the closed Facebook group. The group will be moderated by Dr Jennifer Norman and the Health Promotion Service Media and Communications Officers.
Participants can un-follow the group at any time.
Facebook engagement metrics will be gathered, including likes, comments and shares. These metrics will be used to inform the program content moving forward.

Intervention code [1] 323777 0
Behaviour
Intervention code [2] 323778 0
Lifestyle
Comparator / control treatment
Control group participants will continue with their usual feeding schedules and behaviours and will be invited to join the program in 2023, should the research study prove successful.
Control group
Active

Outcomes
Primary outcome [1] 331695 0
Children’s vegetable intake as determined by a stand-alone item on servings of vegetables per day. This question is taken from the NSW Population Health Survey.
Timepoint [1] 331695 0
Baseline and 8-weeks post-intervention commencement.
Primary outcome [2] 331696 0
Children’s total physical activity (light-intensity physical activity and moderate-to-vigorous physical activity (MVPA)) outside of school hours and on weekend days. These questions are taken from the NSW Population Health Survey.
Timepoint [2] 331696 0
Baseline and 8-weeks post-intervention commencement.
Secondary outcome [1] 410809 0
Children’s recreational sedentary screen time. This will be assessed by two stand alone questions:
1. On a normal school day, how much time would your child spend sitting and using a mobile phone, iPad, tablet, computer, gaming console or watching TV/DVDs?
(Note, this does not include time at school or for homework or educational purposes).
2. On a normal weekend day, how much time would your child spend sitting and using a mobile phone, iPad, tablet, computer, gaming console or watching TV/DVDs?
(Note, this does not include homework or educational purposes).
Timepoint [1] 410809 0
Baseline and 8-weeks post-intervention commencement
Secondary outcome [2] 410810 0
Parents'/carer's vegetable intake as determined by a stand-alone item on servings of vegetables per day. This question is taken from the NSW Population Health Survey.
Timepoint [2] 410810 0
Baseline and 8-weeks post-intervention commencement.
Secondary outcome [3] 410811 0
Parent’s moderate-intensity physical activity as determined by a stand-alone item taken from the two-question Physical Activity (2 Q) assessment tool.

Marshall, A.L., et al., Reliability and validity of a brief physical activity assessment for use by family doctors. Br J Sports Med, 2005. 39(5): p. 294-7
Timepoint [3] 410811 0
Baseline and 8-weeks post-intervention commencement.
Secondary outcome [4] 410888 0
Parent’s vigorous-intensity physical activity as determined by a stand-alone item taken from the two-question Physical Activity (2 Q) assessment tool.

Marshall, A.L., et al., Reliability and validity of a brief physical activity assessment for use by family doctors. Br J Sports Med, 2005. 39(5): p. 294-7
Timepoint [4] 410888 0
Baseline and 8-weeks post-intervention commencement.

Eligibility
Key inclusion criteria
To be able to take part in the study participants will need to: live in the Illawarra Shoalhaven Local Health District (ISLHD); have a child who attends primary school; live with the child for at least 4 days on an average week; have a child who exceeds the recommended sedentary recreational screen time guidelines; have a mobile phone and access to the Internet; and be able to read and understand English.
Minimum age
5 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil outside the inclusion criteria

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample of 240 participants will be needed to detect change between groups with an effect size of d=0.4 (pilot data). This sample size allows for a potential drop-out rate of 15%, and provides 80% power and alpha=0.05.
Process measures will assess participants’ acceptability, utility, and engagement with the text message and Facebook intervention. Linear or generalised linear mixed models will be used to assess the difference between groups over time in all outcome measures while adjusting for relevant covariates.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/07/2022
Actual
1/08/2022
Date of last participant enrolment
Anticipated
3/10/2022
Actual
22/08/2022
Date of last data collection
Anticipated
23/12/2022
Actual
28/10/2022
Sample size
Target
240
Accrual to date
Final
242
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 311633 0
Other Collaborative groups
Name [1] 311633 0
Illawarra Health and Medical Research Institute
Country [1] 311633 0
Australia
Primary sponsor type
Government body
Name
Illawarra Shoalhaven Local Health District
Address
Illawarra Shoalhaven Local Health District, Health Promotion Service.
Level 1, 67-71 King Street Warrawong NSW 2502
Country
Australia
Secondary sponsor category [1] 313070 0
University
Name [1] 313070 0
Early Start, University of Wollongong
Address [1] 313070 0
Early Start, University of Wollongong, Northfields Avenue, Wollongong, NSW, 2502
Country [1] 313070 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311090 0
Joint University of Wollongong and Illawarra Shoalhaven Local Health District Health and Medical Human Research Ethics Committee
Ethics committee address [1] 311090 0
Ethics committee country [1] 311090 0
Australia
Date submitted for ethics approval [1] 311090 0
Approval date [1] 311090 0
02/12/2019
Ethics approval number [1] 311090 0
2019/ETH13171

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

Contacts
Principal investigator
Name 119906 0
Dr Jenny Norman
Address 119906 0
Illawarra Shoalhaven Local Health District, Health Promotion Service 67-71 King Street Warrawong NSW 2502
Country 119906 0
Australia
Phone 119906 0
+61 0407998874
Fax 119906 0
Email 119906 0
[email protected]
Contact person for public queries
Name 119907 0
Jenny Norman
Address 119907 0
Illawarra Shoalhaven Local Health District, Health Promotion Service 67-71 King Street Warrawong NSW 2502
Country 119907 0
Australia
Phone 119907 0
+61 0407998874
Fax 119907 0
Email 119907 0
[email protected]
Contact person for scientific queries
Name 119908 0
Jenny Norman
Address 119908 0
Illawarra Shoalhaven Local Health District, Health Promotion Service 67-71 King Street Warrawong NSW 2502
Country 119908 0
Australia
Phone 119908 0
+61 0407998874
Fax 119908 0
Email 119908 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified primary outcome data will be available once planned publications are complete.
When will data be available (start and end dates)?
Data will be available once our planned publications are published and available for 5 years after publication.
Available to whom?
Subscribers to the journal publications.
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Via the publication journal or via Dr Norman by email enquiry at [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16368Clinical study report    Following study completion and successful publicat... [More Details]
16369Ethical approval    384212-(Uploaded-14-06-2022-16-41-54)-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
No additional documents have been identified.