Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001006134
Ethics application status
Approved
Date submitted
3/07/2019
Date registered
15/07/2019
Date last updated
15/07/2019
Date data sharing statement initially provided
15/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Strategies to increase childcare service registration at healthy menu planning workshops
Scientific title
A randomised controlled trial assessing the impact of nudge strategies on healthy menu planning workshop registration among centre-based childcare services
Secondary ID [1] 298206 0
None
Universal Trial Number (UTN)
NA
Trial acronym
NA
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
Dietary guideline education 312800 0
Condition category
Condition code
Diet and Nutrition 311298 311298 0 0
Obesity
Public Health 311299 311299 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Munch and Move Healthy Menu Planning Workshop is a three hour workshop held in the Hunter New England region of New South Wales. The aim of the workshop is to provide childcare service staff (menu planners and supervisors) with the confidence, knowledge and skills required to plan and provide nutritionally adequate meals to children in care.

Childcare services in the intervention group will be emailed an enhanced invitation six weeks prior to the Munch and Move Healthy Menu Planning Workshop. The email will be distributed by a Health Promotion Officer (HPO) with previous experience working with childcare services.

The enhanced invitation, designed by Health Promotion staff, includes several behavioural ‘nudge’ strategies aiming to increase workshop registration. These strategies include: a testimonial from a previous attendee endorsing the workshop; information highlighting that the workshop contributes to professional development; and a visual reminder to display at the service. These strategies have been previously utilised within other community health promotion activities.

Intervention childcare services who are yet register for the workshop will receive a reminder email, distributed by the same HPO, one week following the initial invitation. The reminder email contains the enhanced invitation, including information regarding the workshop date, time location, and due date for workshop registrations. Childcare services yet to register three weeks following the initial invitation will then receive a reminder phone call from the same HPO to encourage registration. A final reminder email will be distributed to childcare services two weeks prior to the workshop. Internal records by the HPO will be maintained to track delivery of the initial invitation, reminder emails and reminder phone calls.

Childcare services will be asked to register for the workshop by completing a brief online registration form. Workshop attendance will be capped at 30 individuals.
Intervention code [1] 314444 0
Behaviour
Comparator / control treatment
Childcare services in the control arm will be emailed a generic invite six weeks prior to the Munch and Move Healthy Menu Planning Workshop. The invitations will be distributed by a HPO with previous experience working with childcare services.

These generic invitations have been designed by NSW Office of Preventative Health and include information highlighting the relevance of the workshop to the state-based dietary guidelines for the sector, and regulatory standards The generic invitation will not include any deliberate strategies to increase attendance.

Control childcare services who are yet register for the workshop will receive a reminder email, distributed by the same HPO one week following the initial invitation. The reminder email contains the generic invitation, including information regarding the workshop date, time, location, and due date for workshop registrations. Childcare services yet to register three weeks following the initial invitation will then receive a reminder phone call from the same HPO to encourage registration. A final reminder email will be distributed to childcare services two weeks prior to the workshop. Internal records by the HPO will be maintained to track delivery of the initial invitation, reminder emails and reminder phone calls.

Childcare services will be asked to register for the workshop by completing a brief online registration form. Workshop attendance will be capped at 30 individuals.
Control group
Active

Outcomes
Primary outcome [1] 320037 0
Childcare service registration for the Munch and Move Healthy Menu Planning Workshop will be evaluated by comparing the number of childcare services who registered between the intervention and the control arm.
Timepoint [1] 320037 0
The outcome will only be assessed post intervention (on the day of the workshop), approximately six weeks post invitation distribution.
Primary outcome [2] 320038 0
Acceptability of the invitation will be assessed via one item rated on scale (ranging from 1 to 10) administered by a telephone interview. The item was designed specifically for this study Scores will be compared between intervention and control services.
Timepoint [2] 320038 0
The outcome will only be assessed once at follow-up, approximately four months following invitation distribution.
Secondary outcome [1] 370331 0
Childcare service staff intentions to implement dietary guidelines for the sector will be assessed via four items on a 5-point Likert Scale (ranging from strongly agree to strongly disagree) administered by a telephone interview. The items were designed specifically for this study.
Timepoint [1] 370331 0
The outcome will only be assessed once at follow-up, approximately four months following invitation distribution.
Secondary outcome [2] 370332 0
Contextual barriers to workshop attendance will be assessed via five single response items within a telephone interview.
Timepoint [2] 370332 0
The outcome will only be assessed once at follow-up, approximately four months following invitation distribution. The items were designed specifically for this study.

Eligibility
Key inclusion criteria
Centre-based childcare services that are open eight or more hours a day and provide at least one main meal and two snacks to children while in care. Services with menu planners are eligible to participate if they have not participated in a menu planning workshop in the past three years.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Childcare services who have previously been trained in Munch and Move. Childcare services that do not have menu planners, do not provide all meals to children, cater specifically for special needs children, family day care or service located within a specific region (Hunter New England) within NSW will be excluded. Childcare service staff that are unable to complete the survey in English will also be excluded.

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)
A list of childcare services located in the Hunter New England Local Health District (HNELHD) was obtained through internal records. Childcare services who had not participated in menu planning training in the past three years were identified (n=88).
Childcare service random allocation to intervention and control group will take place centrally using the RAND function in Microsoft Excel 2013. Childcare services were blind to group allocation. The HPO and data collectors were aware of group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Childcare services were randomly allocated to intervention and control group using the RAND function in Microsoft Excel 2013. Services will be block randomised to the intervention or control group in a 1:1 ratio.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Only post-intervention measures were obtained. No baseline assessment was undertaken.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analyses will be conducted using SAS 9.3. Descriptive statistics including frequencies, proportions and 95% CIs will be used to describe service characteristics and interview responses. For the primary and secondary outcomes, chi-square and linear regressions will be used to assess differences between intervention and control.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/01/2019
Date of last participant enrolment
Anticipated
Actual
29/01/2019
Date of last data collection
Anticipated
Actual
20/02/2019
Sample size
Target
88
Accrual to date
Final
55
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 302749 0
Government body
Name [1] 302749 0
Hunter New England Population Health
Country [1] 302749 0
Australia
Primary sponsor type
Individual
Name
Alice Grady
Address
University of Newcastle
Booth Building
Longworth Avenue
Wallsend 2287 NSW
Country
Australia
Secondary sponsor category [1] 302683 0
None
Name [1] 302683 0
Address [1] 302683 0
Country [1] 302683 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303349 0
Hunter New England Local Health District Human Research Ethics Committee
Ethics committee address [1] 303349 0
Ethics committee country [1] 303349 0
Australia
Date submitted for ethics approval [1] 303349 0
14/08/2018
Approval date [1] 303349 0
20/12/2018
Ethics approval number [1] 303349 0
06/07/26/4.04

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

Contacts
Principal investigator
Name 93366 0
Dr Alice Grady
Address 93366 0
University of Newcastle
Booth Building
Longworth Avenue
Wallsend 2287 NSW
Country 93366 0
Australia
Phone 93366 0
+61 2 4924 6310
Fax 93366 0
Email 93366 0
[email protected]
Contact person for public queries
Name 93367 0
Alice Grady
Address 93367 0
University of Newcastle
Booth Building
Longworth Avenue
Wallsend 2287 NSW
Country 93367 0
Australia
Phone 93367 0
+61 2 4924 6310
Fax 93367 0
Email 93367 0
[email protected]
Contact person for scientific queries
Name 93368 0
Alice Grady
Address 93368 0
University of Newcastle
Booth Building
Longworth Avenue
Wallsend 2287 NSW
Country 93368 0
Australia
Phone 93368 0
+61 2 4924 6310
Fax 93368 0
Email 93368 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
Ethical approval of the study did not contain approval for participant data to be made available to individuals outside of the research team. De-identifiable participant data may be made available upon request to the authors, pending submission and approval of an amendment to the current ethics application.


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.