Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000712505
Ethics application status
Approved
Date submitted
21/06/2015
Date registered
9/07/2015
Date last updated
15/06/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The use of printed education materials to increase intentions to use nutrition guidelines amongst childcare centres.
Scientific title
A randomised controlled trial assessing the impact of printed education materials to increase childcare service cooks intentions to implement nutrition guidelines while planning their menus, compared to usual care.
Secondary ID [1] 286835 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
implementation of dietary guidelines 295220 0
preventive condition - dietary intake and obesity prevention 295221 0
Condition category
Condition code
Diet and Nutrition 295467 295467 0 0
Obesity
Public Health 295515 295515 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Childcare centre cooks in the intervention arm will be mailed a hard copy printed education material together with sections of the nutrition guidelines relevant to menu planning. The design of the printed education material will be theory informed and based on evidence from key systematic reviews in the field. The printed education material will be printed a single A4-sized, double sided and laminated resource. The material will only be mailed out on a single occasion. No other strategy to encourage use of the resource will be undertaken. The number of intervention resourced returned and not successfully mailed out will be recorded internally.
Intervention code [1] 291995 0
Prevention
Intervention code [2] 291996 0
Lifestyle
Comparator / control treatment
Childcare centres in the control arm will receive usual care and no other intervention from the research team. These services all have access to the guidelines online and may have received a hard copy version of the guideline from health promotion units within their district.
Control group
Active

Outcomes
Primary outcome [1] 295194 0
Intentions to apply nutrition guidelines to menu planning in services will be assessed using a four items on 7-point Likert Scale (strongly agree to strongly disagree) administered by a telephone interview.
Timepoint [1] 295194 0
The outcome will only be assessed once at six to ten weeks from mail out of the printed education material.
Primary outcome [2] 295436 0
Compliance of menu with nutrition guidelines will be assessed by asking cooks to report on the number of serves of food groups provided on their menu via a telephone interview.
Timepoint [2] 295436 0
The outcome will only be assessed once at six to ten weeks from mail out of the printed education material.
Secondary outcome [1] 315090 0
Attitudes of cooks towards applying the guidelines will be assessed using five items on a 7-point Likert Scale administered by a telephone interview.
Timepoint [1] 315090 0
The outcome will only be assessed once at six to ten weeks from mail out of the printed education material.
Secondary outcome [2] 315189 0
Behavioural regulation (or perceived behavioral control) in regards to implementing the guidelines will be assessed using a six items on a 7-point Likert Scale administered by a telephone interview.
Timepoint [2] 315189 0
The outcome will only be assessed once at six to ten weeks from mail out of the printed education material.
Secondary outcome [3] 315190 0
Social influence in regards to implementing the guidelines will be assessed via six items on a 7-point Likert Scale administered by a telephone interview.
Timepoint [3] 315190 0
The outcome will only be assessed once at six to ten weeks from mail out of the printed education material.

Eligibility
Key inclusion criteria
Cooks of centre-based childcare centers that are open eight or more hours a day and provide the majority of food to children while in care. Cooks are only eligible to participate if they are involved in planning the menus.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Childcare centres that do not have cooks, 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. Cooks that are unable to complete the survey in English will also be excludeed.

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 service centres located in the New South Wales region (excluding the Hunter New England region) was obtained using a central government repository. A random sample of services was selected from the list. A research assistant examined whether each of the service provided meals to children by searching center websites. Eligible services were randomised to receive either the printed education material or usual care.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Childcare centres were randomly allocated to intervention and control group using the RAND function in excel by a statistician independent to 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
Only post-intervention measures were obtained. No baseline assessment was undertaken. Centres will only be recruited into the trial if they consent to completing the post-intervention CATI.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We required 154 participants to have 80% power of detecting an effect size of 0.45 standard deviations, with a significance level of 5%. Assuming a 70% response rate at follow up, we will approach 220 centres. An ANCOVA will be undertaken to assess the impact of the intervention on the primary oucome - intentions to use.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/07/2015
Actual
15/07/2015
Date of last participant enrolment
Anticipated
Actual
30/09/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
154
Accrual to date
Final
77
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 291401 0
Government body
Name [1] 291401 0
Hunter New England Population Health
Country [1] 291401 0
Australia
Primary sponsor type
Individual
Name
Sze Lin Yoong
Address
University of Newcastle
Booth Building
Longworth Avenue
Wallsend 2287 NSW
Country
Australia
Secondary sponsor category [1] 290186 0
Individual
Name [1] 290186 0
Luke Wolfenden
Address [1] 290186 0
University of Newcastle
Booth Building
Longworth Avenue
Wallsend 2289 NSW
Country [1] 290186 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292949 0
Hunter New England Local Health District Human Research Ethics Committee
Ethics committee address [1] 292949 0
Ethics committee country [1] 292949 0
Australia
Date submitted for ethics approval [1] 292949 0
Approval date [1] 292949 0
26/06/2015
Ethics approval number [1] 292949 0
06/07/26/4.04

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

Contacts
Principal investigator
Name 57722 0
Dr Sze Lin Yoong
Address 57722 0
University of Newcastle
Booth Building
Longworth Avenue
Wallsend 2287 NSW
Country 57722 0
Australia
Phone 57722 0
+612 4924 6413
Fax 57722 0
Email 57722 0
[email protected]
Contact person for public queries
Name 57723 0
Sze Lin Yoong
Address 57723 0
University of Newcastle
Booth Building
Longworth Avenue
Wallsend 2287 NSW
Country 57723 0
Australia
Phone 57723 0
+612 49246413
Fax 57723 0
Email 57723 0
[email protected]
Contact person for scientific queries
Name 57724 0
Sze Lin Yoong
Address 57724 0
University of Newcastle
Booth Building
Longworth Avenue
Wallsend 2287 NSW
Country 57724 0
Australia
Phone 57724 0
+612 49246413
Fax 57724 0
Email 57724 0
[email protected]

No information has been provided regarding IPD availability


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.