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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ANZCTR
Last refreshed on: 13 January 2020
Main ID:  ACTRN12615001032549
Date of registration: 01/10/2015
Prospective Registration: Yes
Primary sponsor: Hunter New England Population Health
Public title: A randomised controlled trial of an intervention to improve the implementation of nutrition guidelines in childcare services
Scientific title: The impact of a multi-strategy childcare-based intervention to improve compliance with nutrition guidelines versus usual care in long day care services on child intake while in care.
Date of first enrolment: 27/10/2015
Target sample size: 58
Recruitment status: Completed
URL:  https://anzctr.org.au/ACTRN12615001032549.aspx
Study type:  Interventional
Study design:  Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;  
Phase:  Not Applicable
Countries of recruitment
Australia
Contacts
Name: Ms Kirsty Seward   
Address:  Hunter New England Population Health Locked Bag 10 Wallsend, New South Wales 2287 Australia
Telephone: +61 2 4924 6565
Email: Kirsty.seward@hnehealth.nsw.gov.au
Affiliation: 
Name: Ms Kirsty Seward   
Address:  Hunter New England Population Health Locked Bag 10 Wallsend, New South Wales 2287 Australia
Telephone: +61 2 4924 6565
Email: Kirsty.seward@hnehealth.nsw.gov.au
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: Long Day Care Services: For a service to be eligible, it will be located within the Hunter and 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. Services must conduct menu planning processes internally (ie, services do not out-source menu planning)
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

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females
Health Condition(s) or Problem(s) studied
Public Health - Health promotion/education
Diet and Nutrition - Obesity
Childhood overweight and obesity;
Childhood overweight and obesity
Intervention(s)
An intervention to improve childcare service implementation of nutrition guidelines (i.e. approximately 50% of serves as specified by the Australian dietary guidelines) will be delivered to eligible long day care centres over six months. The intervention will primarily target childcare service managers and service cooks. Strategy selection will be guided by the theoretical domains framework and consist of the following implementation strategies:

1. Provision of staff training: Service managers and service cooks will be provided with a one-day workshop. The workshop will be delivered by experienced dietitians and health promotion staff and focus on improving skills and knowledge related to menu planning.

2. Provision of resources: A resource pack will be provided to all intervention services. The pack will include the Caring for Children resource, menu planning checklists and recipe ideas. The Caring for children resource, developed by the NSW Ministry of health and summarises best practice nutrition guidelines for the sector and has a focus on menu planning.

3. Ongoing support: An implementation support officer will be allocated to each intervention service. Two face-to-face contacts (duration 1-2 hours), will be provided to intervention services 1 month and 3 months following the menu planning workshop. During the support contacts the service manager and service cook will receive expert advice and support from their allocated support officer to facilitate the implementation of nutrition guidelines.

4. Audit and feedback: Menus of intervention services will be assessed for compliance by a dietitian and feedback provided to implementation support officers at two time points (baseline and 4 months). The implementation support officer will th
Primary Outcome(s)
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),
This outcome will be assessed by comprehensive two-week menu reviews undertaken by a dietitian who is blinded to group allocation. [At baseline, at the end of the intervention period (approximately 6-months post baseline) and 6 months post intervention (12 months post-baseline). ]
Change in proportion of services who have a two week menu that is compliant with nutrition guidelines (provides 50% of children’s RDI)[At baseline and at the end of the intervention period (approximately 6-months post-baseline)]
Secondary Outcome(s)
Intervention acceptability -As part of the follow-up pen and paper questionnaires, services allocated to the intervention group will answer items related to the use, appropriateness and satisfaction with the resources, training and ongoing support provided by the implementation team. Both the service cook and service manager will answer these acceptability items. The items are not validated and will be similar to those used by the research team to evaluate previous health promotion programmes in childcare services[End of intervention (6-months post-baseline)]
Context -A systematic search will be conducted to aid the assessment of the external validity of the trial findings and to describe the context in which the trial was conducted. The search will include national and state education websites, local newspaper archives and accreditation and national healthy eating recommendations and guidelines to identify any changes in government policy, standards, sector accreditation requirements and nutrition guidelines that may impact on the healthy eating environment and the provision of healthy foods within the childcare setting. The date of events and release of promotional materials related to the dissemination of the Caring for Children resource will also be documented[The search will include the 12 months prior to and the 6 months during intervention delivery.]
Delivery of intervention strategies- Project records maintained by implementation support staff will be used to monitor and assess the delivery and uptake of each of the intervention strategies.[End of intervention (6-months post-baseline)]
Contamination and co-intervention - Intervention contamination and receipt of other interventions provided separate to the trial will be assessed via pen and paper questionnaires completed by service cooks and service managers both in intervention and
control groups at follow-up. The questionnaire items will assess if the control services were exposed to any intervention materials or support during the study period. If the participants received any additional support to improve menu planning or food preparation during the study period, they will be asked to describe such support.[End of intervention (6-months post-baseline)]
Post-intervention between-group differences in the theoretical domains framework constructs targeted by the intervention will be assessed as a process measure as part of the cook’s pen and paper follow-up questionnaire. [End of intervention period (6-months post-baseline)]
Child dietary intake as assessed using aggregate level plate waste measures and self-reported questionnaire completed by childcare providers. The questionnaire was adapted from a previously validated dietary index short food survey (Hendrie, 2012). [At baseline and at the end of the intervention period (6-months post-baseline) ]
Secondary ID(s)
NIL
Source(s) of Monetary Support
University of Newcastle
Hunter New England Population Health
Secondary Sponsor(s)
University of Newcastle
Ethics review
Status: Approved
Approval date:
Contact:
Hunter New England Human Research Ethics Committee
Results
Results available:
Date Posted:
Date Completed:
URL:
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