Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000506190
Ethics application status
Approved
Date submitted
22/03/2019
Date registered
28/03/2019
Date last updated
4/03/2020
Date data sharing statement initially provided
28/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the effectiveness of methods to recruit schools to an app-based nutrition program.
Scientific title
A randomised controlled trial to evaluate methods to recruit schools to an app-based nutrition program.
Secondary ID [1] 297775 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recruitment to obesity intervention 312122 0
Condition category
Condition code
Public Health 310675 310675 0 0
Health promotion/education
Diet and Nutrition 310704 310704 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interventional

A randomised design will be utilised to test the effectiveness of methods to recruit schools to the SWAP IT program, an app-based nutrition program aimed at improving what is packed in lunchboxes. The trial will assess whether recruitment via Skoolbag, the app provider, is more effective than the usual recruitment methods via Health Promotion Officers employed through the state health department.

All Schools in the target sample are existing users of Skoolbag, a school to parent communication app.

Schools will be randomly allocated to either the intervention arm, recruitment via Skoolbag; or control arm, recruitment via usual methods. The trial will run for approximately 4 weeks.

The intervention group will receive an initial email and up to two follow up emails over a 4 week period, from Skoolbag, inviting participation in the SWAP IT program. The emails contain a link to complete an expression of interest form and a flyer outlining the SWAP IT program. The invitation emails will be sent from Skoolbag head office to their usual contact at the schools. A list of participating schools, timing and content of the emails will be provided to Skoolbag by the Trial Principal Investigator or his delegate.
Intervention code [1] 314013 0
Behaviour
Comparator / control treatment
Usual practice – schools will be contacted by the school’s allocated Health Promotion Officer via usual methods, which may include email, phone or face-to-face contact.
Control group
Active

Outcomes
Primary outcome [1] 319521 0
Percentage difference in successful recruitment of schools to an app-based nutrition program, when recruited via invitation email from the app provider versus usual contact via the school’s allocated Health Promotion Officer. This will be assessed by comparison of number/percent of expressions of interest received to participate in the program offered.
Timepoint [1] 319521 0
Assessed at 4 weeks after the initial invitation is sent via both recruitment methods.
Secondary outcome [1] 368564 0
Percentage difference in successful recruitment of schools to an app-based nutrition intervention, when recruited via invitation email from the app provider versus usual contact via the schools allocated health promotion officer at each of the three time points, approximately one week apart. This will be assessed by comparison of number/percent of expressions of interests received at the end of weeks 1, 2 and 3.
Timepoint [1] 368564 0
Assessed at the end of weeks 1, 2, and 3.

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, Skoolbag.
Minimum age
18 Years
Maximum age
No limit
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, schools not utilising the Skoolbag communication app and/or schools who have already implemented the app-based nutrition program.

Study design
Purpose of the study
Educational / counselling / training
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
Completed
Date of first participant enrolment
Anticipated
1/04/2019
Actual
1/04/2019
Date of last participant enrolment
Anticipated
Actual
12/04/2019
Date of last data collection
Anticipated
Actual
31/07/2019
Sample size
Target
76
Accrual to date
Final
70
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 302301 0
Charities/Societies/Foundations
Name [1] 302301 0
Nib Foundation
Country [1] 302301 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 302177 0
Government body
Name [1] 302177 0
Hunter New England Population Health
Address [1] 302177 0
Locked Bag 10
Wallsend NSW 2287
Country [1] 302177 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302975 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 302975 0
Ethics committee country [1] 302975 0
Australia
Date submitted for ethics approval [1] 302975 0
Approval date [1] 302975 0
23/08/2018
Ethics approval number [1] 302975 0
HREC 0607264.04

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

Contacts
Principal investigator
Name 92038 0
A/Prof Luke Wolfenden
Address 92038 0
Hunter New England Population Health
Locked Bag 10
Wallsend, NSW Australia 2287
Country 92038 0
Australia
Phone 92038 0
+61 2 4924 6499
Fax 92038 0
+61 2 4924 6490
Email 92038 0
[email protected]
Contact person for public queries
Name 92039 0
Rachel Sutherland
Address 92039 0
Hunter New England Population Health
Locked Bag 10
Wallsend, NSW 2287
Country 92039 0
Australia
Phone 92039 0
+61 2 4924 6499
Fax 92039 0
+61 2 4924 6490
Email 92039 0
[email protected]
Contact person for scientific queries
Name 92040 0
Rachel Sutherland
Address 92040 0
Hunter New England Population Health
Locked Bag 10
Wallsend, NSW 2287
Country 92040 0
Australia
Phone 92040 0
+61 2 4924 6499
Fax 92040 0
+61 2 4924 6490
Email 92040 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.