Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001058561
Ethics application status
Approved
Date submitted
28/09/2015
Date registered
12/10/2015
Date last updated
2/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of an intervention to improve the implementation of food service nutrition guidelines in childcare centres that provide food to children
Scientific title
The impact of a training intervention versus usual care on compliance with food service nutrition guidelines in long day care services.
Secondary ID [1] 287556 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood overweight and obesity 296331 0
Condition category
Condition code
Public Health 296607 296607 0 0
Health promotion/education
Diet and Nutrition 296608 296608 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 6 month intervention to improve childcare service implementation of nutrition guidelines will be delivered. The intervention will consist of: cook and service manager training to improve knowledge and skills in regards to the menu planning (service managers and service cooks will be provided with a single one-day menu planning workshop, delivered by experienced dietitians and health promotion staff).; provision of resources including a resource manual, menu planning checklists and recipe ideas; review of service menus and feedback at one month following the workshop.
Intervention code [1] 292955 0
Prevention
Intervention code [2] 292998 0
Lifestyle
Comparator / control treatment
No treatment, standard care – participating services randomised to the wait list control group will receive the intervention after follow-up data collection.
Control group
Active

Outcomes
Primary outcome [1] 296225 0
Change in proportion of services who have a two week menu that is compliant with nutrition guidelines (provides 50% of recommended serves as specified by the Australian dietary guidelines).Menu audits will be undertaken by a dietitian blinded to intervention allocation.
Timepoint [1] 296225 0
At baseline, end of intervention (6 months post-baseline) and 6 months post intervention (12 months post -baseline)
Secondary outcome [1] 317871 0
Change in proportion of services who are compliant with the nutrition guidelines for individual Australian Guide to healthy Eating food groups ((1) Vegetables and legumes/beans; (2) Fruit; (3) Wholegrain cereal foods and breads; (4) Lean meat and poultry, fish, eggs, tofu, seeds and legumes; (5) Milk, yoghurt, cheese and alternatives; and (6) Discretionary foods).
As per the sector nutrition guidelines services are required to provided: 2 serves of the vegetable and legumes/beans food group; 1 serve of the fruit food group; 2 serves of the wholegrain cereals and breads food group; 0.75 serve of Lean meat and poultry, fish, eggs, tofu, seeds and legumes food group; 1 serve of Milk, yoghurt, cheese and alternative food group and; 0 serves of discretionary foods, per child each day. A service will be deemed compliant with a food group if their planned menu provides the recommended serve of the food group for each child on everyday across the 2 week menu (10 days),
Menu audits will be undertaken by a dietitian blinded to intervention allocation.
Timepoint [1] 317871 0
At baseline, end of intervention (6 months post-baseline) and 6 months post intervention (12 months post -baseline)

Eligibility
Key inclusion criteria
Long Day Care Services: For a service to be eligible, it will be located within the Hunter New England region of NSW Australia, provide all meals (at least one main meal and two mid-meals) to children while they are in care, and open for at least 8 hours per day.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Long Day Care Services: Services that do not prepare and provide meals to children onsite or do not have a cook with some responsibility for menu planning will be excluded from the study. Further, services catering exclusively for children requiring specialist care, mobile preschools and family day care centres will also be excluded from the study]
A sample of 70 services in the Hunter New England Region (n=111) will be randomly approached to participate in the trial

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Study information and consent forms will be mailed to services approximately one to two weeks prior to a telephone call from a research assistant requesting consent to participate in data collection. Random allocation to groups will be conducted by an independent statistician, at a centralised location.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Consenting childcare services will be randomly allocated to an intervention or control group in a 1:1 ratio via block randomisation using a random number function in SAS statistical software following baseline data collection. Allocation of services will be undertaken by a statistician who will otherwise have no involvement in the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/10/2015
Actual
27/10/2015
Date of last participant enrolment
Anticipated
Actual
30/11/2015
Date of last data collection
Anticipated
Actual
30/09/2016
Sample size
Target
60
Accrual to date
Final
47
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 292125 0
Government body
Name [1] 292125 0
Hunter New England Population Health
Country [1] 292125 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Population Health
Address
Longworth Avenue, Wallsend, NSW 2287
Country
Australia
Secondary sponsor category [1] 290799 0
University
Name [1] 290799 0
University of Newcastle
Address [1] 290799 0
University Drive, Callaghan NSW 2308
Country [1] 290799 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293603 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 293603 0
Ethics committee country [1] 293603 0
Australia
Date submitted for ethics approval [1] 293603 0
01/09/2015
Approval date [1] 293603 0
24/09/2015
Ethics approval number [1] 293603 0
06/07/26/4.04

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

Contacts
Principal investigator
Name 60642 0
Ms Meghan Finch
Address 60642 0
Hunter New England Population Health
Locked Bag 10
Wallsend, New South Wales 2287
Country 60642 0
Australia
Phone 60642 0
+61 2 4924 6131
Fax 60642 0
+61 2 4924 6215
Email 60642 0
[email protected]
Contact person for public queries
Name 60643 0
Meghan Finch
Address 60643 0
Hunter New England Population Health
Locked Bag 10
Wallsend, New South Wales 2287
Country 60643 0
Australia
Phone 60643 0
+61 2 4924 6131
Fax 60643 0
+61 2 4924 6215
Email 60643 0
[email protected]
Contact person for scientific queries
Name 60644 0
Meghan Finch
Address 60644 0
Hunter New England Population Health
Locked Bag 10
Wallsend, New South Wales 2287
Country 60644 0
Australia
Phone 60644 0
+61 2 4924 6131
Fax 60644 0
+61 2 4924 6215
Email 60644 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.