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Trial registered on ANZCTR


Registration number
ACTRN12616000974404
Ethics application status
Approved
Date submitted
20/06/2016
Date registered
25/07/2016
Date last updated
10/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of a web-based, menu planning intervention on childcare provision of food in line with dietary guidelines
Scientific title
A randomised controlled trial of an online menu-planning intervention to improve childcare service adherence to dietary guidelines
Secondary ID [1] 289015 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dietary intake 298429 0
Condition category
Condition code
Public Health 298527 298527 0 0
Health promotion/education
Public Health 298528 298528 0 0
Health service research
Diet and Nutrition 299387 299387 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is an online menu planning tool, that is incorporated within the usual mandatory web-based reporting systems of Australian childcare centres (childcare management software (CCMS)). It will primarily target menu planners (i.e. cooks) and childcare service managers, and seek to ensure that foods provided by childcare services adhere with dietary guidelines consistent with accreditation standards for the sector.

The intervention will be delivered across approximately 12 months and specifically target menu planners and service supervisors.
The components of the intervention are as below:
a) Automated menu planning and decision support: The web-based program will enable menu planners to undertake electronic meal planning by selecting pre-entered recipes or adding new meals/snacks into the menu planning tool. The program will provide an automated assessment of menu adherence to dietary guidelines, based on the meal combinations entered food combinations included in menu plans and calculate the number of serves provided from of each of the food groups according to the Australian Dietary Guidelines. Information on child allergies already entered into the CCMS software will also be used to ensure meal plans support overall service needs.

b) Feedback, prompts and reminders: The program will provide menu planners with real time feedback on the number of food groups on their menu and whether that meets dietary guidelines. Cooks will be supported to identify relevant meal/snack ideas or substitutions to enable menu adherence. Where menus do not adhere to the guidelines or where services are not engaging, an alert will appear on the front page linked to the CCMS reporting section, prompting service managers to discuss these with menu planners and encourage amendment.

c) Communication strategies and managerial support: Each service's daily menu will be automatically displayed to parents of children attending care via the parent portal of the CCMS software. Daily reports of adherence can also be generated and displayed in the service. To facilitate broad support for healthy meal provision, service managers will be prompted to send parents and service staff evidence-based information regarding child nutrition. They will also communicate service responsibilities to serve food consistent with guidelines and promote the benefits of good nutrition on child health, behaviour and well-being. Service managers will be encouraged to demonstrate their support and endorsement of guideline adherence to menu planners and other service staff.

d) Training and support to use new systems: Technical support will be provided to services to introduce the system, and troubleshoot any problems related to use. Specifically, one face-to-face half-day training session with menu planners and services managers will be undertaken by health promotion staff with relevant health qualifications. This training will provide information related to the updated childcare specific guidelines, demonstrate use of the web based program and answer any queries services may have in relation to adherence to guidelines as well as provide support to use the program to change/update their menus. Across the 12 months, depending on needs, services will also receive three additional telephone contacts (support calls will vary in duration between 15 -45 minutes) by support staff primarily to identify and address any impediments to use, and be offered online telephone training if required. Services will be sent one newsletter promoting the online program. Services will also be able to access general technical support as well as menu planning support via the 'Help-desk' of the CCMS program already used by service for all other general queries with the program. All queries will be responded to online by health service staff with knowledge of the program and menu guidelines.

e) Other online resources: Additional resources including useful tips to engage with the system, fact sheets about menu planning, sample menus, nutrition policies and other useful resources will be made available via the online program.

f) Provision of portable tablets: All intervention services will be supplied with a tablet to maximise integration of the system and allow portable access to the program during meal preparation.

The support staff will log the delivery and brief content of each support call on a monitoring spreadsheet. The research team will also have access to an electronic log of the frequency and duration of service login into the web-based program.
Intervention code [1] 294500 0
Prevention
Comparator / control treatment
The control group will continue to access their usual CCMS software and will not receive any additional support from the research team. Services will not receive access to the menu planning program until after the follow up period (approximately 12-15 months post baseline data collection).
Control group
Active

Outcomes
Primary outcome [1] 298016 0
Primary trial outcome measure – Menu adherence to sector specific guidelines (number of food groups where service menus meets the recommendations of guidelines): The primary outcome of the trial will be the mean number of food groups on the menu that meet dietary guideline recommendation. According to the guidelines for the sector, childcare menus need to provide at least 50% of the recommended number of serves for the following food groups: i) fruit (1 serve), ii) vegetables and legumes/beans (2 serves), iii) wholegrain cereal foods and breads (2 serves), iv) milk, yoghurt, cheese (and/or alternatives) (1 serve), v) lean meat and poultry, fish, eggs, tofu, seeds and legumes (0.75 serves) vi) and no discretionary foods. Each service will receive a possible score out of six. Adherence will be assessed via a comprehensive one-week menu review by a dietitian or nutritionist, the recommended practice for assessing usual food provision. Information regarding food recipes, number of children each recipe caters for and product information will be collected by the research team. Each service’s one-week menu will be entered into the web-based menu planning tool, which will calculate menu adherence.
Timepoint [1] 298016 0
Baseline and approximately 3 and 12 months post intervention (12 months is the primary time point)
Secondary outcome [1] 324956 0
Child BMI z-score - Child weight and height (adjusted for age and gender) will be measured by trained research assistants using a digital scale (NUWEIGHT LOF842) and standing stadiometer (Charder HM 200P stadiometers) in a subsample of up to 35 services.
Timepoint [1] 324956 0
Baseline and approximately 12 months post intervention
Secondary outcome [2] 325434 0
Child diet while in care will be measured using a repeat cross-sectional design via direct observation for a subsample of up to 35 services. Observations will be undertaken using an adapted version of the validated Dietary Observation for Child Care system food record tool. Two trained and blinded research assistants will be present for core service meal times. For each child, the research assistant will document the types and portion sizes of food and beverages consumed, and observe the spillage and sharing that occurs during meal times. At the end of each meal, children’s plate wastage will also be assessed using a standard protocol adapted from previous studies. Child dietary intake outside of care (assessed via a parent questionnaire) will be collected to assess for potential compensatory dietary behaviours. In addition, childcare educators will complete a brief food intake record about the foods usually eaten by children during care hours.
Timepoint [2] 325434 0
Baseline and approximately 12 months post intervention
Secondary outcome [3] 325435 0
Proportion of services providing the appropriate number of wholegrain cereal foods and breads on the menus to meet nutrition guidelines (2 serves). Similar to the primary outcome, adherence will be assessed via a comprehensive one-week menu review by a dietitian or nutritionist, the recommended practice for assessing usual food provision. Each service’s one-week menu will be entered into the web-based menu planning tool, which will calculate food group adherence.
Timepoint [3] 325435 0
Baseline and approximately 3 and 12 months post intervention
Secondary outcome [4] 325436 0
Proportion of services providing the appropriate number of lean meat and poultry, fish, eggs, tofu, seeds and legumes on the menus to meet nutrition guidelines (0.75 serve). Similar to the primary outcome, adherence will be assessed via a comprehensive one-week menu review by a dietitian or nutritionist, the recommended practice for assessing usual food provision. Each service’s one week menu will be entered into the web-based menu planning tool to calculate food group adherence.
Timepoint [4] 325436 0
Baseline and approximately 3 and 12 months post intervention
Secondary outcome [5] 325437 0
Proportion of services providing the appropriate number of milk, yoghurt, cheese and alternatives on the menus to meet nutrition guidelines (1 serve). Similar to the primary outcome, adherence will be assessed via a comprehensive one-week menu review by a dietitian or nutritionist, the recommended practice for assessing usual food provision. Each service’s one week menu will be entered into the web-based menu planning tool to calculate food group adherence.
Timepoint [5] 325437 0
Baseline and approximately 3 and 12 months post intervention
Secondary outcome [6] 325438 0
Proportion of services providing no 'discretionary' food. Similar to the primary outcome, adherence will be assessed via a comprehensive one-week menu review by a dietitian or nutritionist, the recommended practice for assessing usual food provision. Each service’s one week menu will be entered into the web-based menu planning tool to calculate food group adherence.
Timepoint [6] 325438 0
Baseline and approximately 3 and 12 months post intervention
Secondary outcome [7] 325751 0
Proportion of services providing the appropriate number of serves vegetables and legumes/beans on their menus to meet nutrition guidelines (2 serves). Similar to the primary outcome, adherence will be assessed via a comprehensive one-week menu review by a dietitian or nutritionist, the recommended practice for assessing usual food provision. Each service’s one week menu will be entered into the web-based menu planning tool to calculate food group adherence.
Timepoint [7] 325751 0
Baseline and approximately 3 and 12 months post intervention
Secondary outcome [8] 325752 0
Proportion of services providing the appropriate number of fruit on the menus to meet nutrition guidelines (1 serve). Similar to the primary outcome, adherence will be assessed via a comprehensive one-week menu review by a dietitian or nutritionist, the recommended practice for assessing usual food provision. Each service’s one week menu will be entered into the web-based menu planning tool to calculate food group adherence.
Timepoint [8] 325752 0
Baseline and approximately 3 and 12 months post intervention
Secondary outcome [9] 325753 0
Proportion of service meeting guidelines Services will be classed as meeting the guidelines if they provide at least 50% of the recommended number of serves for ALL the following food groups: : i) fruit (1 serve), ii) vegetables and legumes/beans (2 serves), iii) wholegrain cereal foods and breads (2 serves), iv) milk, yoghurt, cheese (and/or alternatives) (1 serve), v) lean meat and poultry, fish, eggs, tofu, seeds and legumes (0.75 serves), and vi) and no discretionary foods Similar to the primary outcome, full compliance will be assessed via a comprehensive one-week menu review by a dietitian or nutritionist, the recommended practice for assessing usual food provision. Each service’s one week menu will be entered into the web-based menu planning tool to calculate food group adherence.
Timepoint [9] 325753 0
Baseline and approximately 3 and 12 months post intervention
Secondary outcome [10] 336873 0
Child health related quality of life will be collected via telephone interview with parents of participating children within a subsample of up to 35 services. Health-related quality of life will be assessed via the parent version of KIDSCREEN-10.
Timepoint [10] 336873 0
Baseline and approximately 12 months post intervention.

Eligibility
Key inclusion criteria
Childcare care services will be the primary participants in the trial. Services will be eligible to participate if they:
1. are current users of the partner childcare management software (CCMS) provider
2. are open for 8 or more hours a day
3. provide at least one main meal and two snacks to children during the day on their menus
4. have someone at the service that has direct involvement in determining the types of foods provided on menus
5. have a menu planner that can understand English sufficiently to engage with the intervention
6. do not cater exclusively for special needs children
7. are not a Department of Education and Communities run service
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Services will be excluded if they :
1. do not provide meals to children onsite
2. cater exclusively to specials need children
3. do not undertake menu planning within the service
4. are a Department and Education and communities run service
5. do not have a menu planner that understands English sufficiently to provide consent
6. do not cater to children aged 3-6 years

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)
Services will be randomly allocated using a block randomisation procedure in a 1:1 ratio to either the intervention or control group and stratified by socioeconomic status by an independent statistician using a computerised random number function. Recruiters, data collectors and assessors will be blinded to group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An independent statistician will generate sequence allocation using a computerised random number function.
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
The collection of child diet, health-related quality of life, and height and weight data will utilise a repeat cross sectional design given challenges with following up the same children in a childcare service setting and expected high attrition using a cohort design. Up to 420 children will be recruited.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The impact of the intervention on the primary trial outcome will be assessed using linear regression models under an intention to treat framework. The primary trial end-point will be 12-months follow-up. Assessment of the short-term impact of the intervention (three months) will be conducted as a secondary measure.

The primary end point will be assessed at the service level.
For the continuous outcome, a sample size of 42 services will allow us to detect a difference in adherence of 0.86 food groups with 80% power and an alpha 0f 0.05, with a standard deviation of 0.97 (based on pilot data).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 293385 0
Government body
Name [1] 293385 0
National Health and Medical Research Council
Address [1] 293385 0
National Health and Medical Research Council GPO Box 1421 Canberra ACT 2601
Country [1] 293385 0
Australia
Funding source category [2] 293386 0
Charities/Societies/Foundations
Name [2] 293386 0
National Heart Foundation
Address [2] 293386 0
80 William St, Woolloomooloo NSW 2011
Country [2] 293386 0
Australia
Primary sponsor type
Individual
Name
Dr Serene (Sze Lin) Yoong
Address
University of Newcastle, c/o Booth Building, Longworth Avenue, Wallsend NSW 2287
Country
Australia
Secondary sponsor category [1] 292204 0
Individual
Name [1] 292204 0
A/Prof Luke Wolfenden
Address [1] 292204 0
University of Newcastle, c/o Booth Building, Longworth Avenue, Wallsend NSW 2287
Country [1] 292204 0
Australia
Other collaborator category [1] 278948 0
Commercial sector/Industry
Name [1] 278948 0
Healthy Australia
Address [1] 278948 0
Suite 309 Exchange Tower
530 Little Collins Street
Melbourne, VIC, 3000
Country [1] 278948 0
Australia
Other collaborator category [2] 278949 0
Government body
Name [2] 278949 0
Hunter New England Population Health
Address [2] 278949 0
Longworth Avenue, Booth Building Wallsend 2287 NSW
Country [2] 278949 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294842 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 294842 0
Locked Bag No: 1
New Lambton NSW 2305
Ethics committee country [1] 294842 0
Australia
Date submitted for ethics approval [1] 294842 0
05/02/2016
Approval date [1] 294842 0
29/03/2016
Ethics approval number [1] 294842 0
6/02/17/4.05

Summary
Brief summary
As dietary patterns established in early childhood track into adulthood, interventions to improve children’s diets are a key focus of national chronic disease prevention strategies. The World Health Organization recommends the implementation of dietary guidelines in childcare settings to improve child health and prevent the development of non-communicable diseases. As such, most developed countries including Australia have sector specific regulations requiring that foods served to children attending childcare is consistent with national dietary guidelines. Research conducted by the research team, however, shows that less than 5% of Australian childcare services adhere to such guidelines. An online menu planning intervention (integrated into mandatory service operating systems) may represent a potentially effective, low-cost, and acceptable means of providing population-level support to childcare services to improve the nutritional quality of food provided in services. This study will assess the effectiveness of a web-based intervention in increasing adherence of childcare service menus to sector specific nutrition guidelines. The study will employ a parallel group cluster randomised controlled trial design with 54 long day care services in New South Wales. Services will be randomised to receive either the web-based intervention integrated into current childcare management reporting software or the control group. The primary trial outcome is the adherence to the nutrition guidelines regarding provision of fruit; vegetable; grains; milk, yoghurt, cheese (and/or alternatives); meat (and/or meat alternatives) and discretionary foods (foods high in energy, fat and/or salt) as assessed via a comprehensive menu review undertaken by a blinded dietitian or nutritionist. In a nested sample of up to 35 services child dietary intake in care will also be assessed
Trial website
Trial related presentations / publications
Publications
Yoong S, Grady A, Wiggers J, Flood V, Rissel C, Finch M, Searles A, Salajan D, O’Rourke R, Daly J, Gilham K, Stacey F, Fielding A, Pond N, Wyse R, Seward K, Wolfenden L. A randomised controlled trial of a web-based menu planning intervention to improve childcare service adherence to dietary guidelines: a study protocol. BMJ Open 2017;7:e017498. doi:10.1136/bmjopen-2017-017498

Presentations
Yoong S, Grady A, Wiggers J, Finch M, Seward K, Stacey F, Fielding A, Searles A, Rissel C, Daly J, Gilham K, Pond N, Wyse R, Flood V, Wolfenden L. A randomised controlled trial of a web-based menu planning, systems intervention to improve childcare service menu adherence to dietary guidelines. Global Implementation Conference 20 – 21 June 2017, Toronto, Canada.
Public notes

Contacts
Principal investigator
Name 57646 0
A/Prof Luke Wolfenden
Address 57646 0
University of Newcastle, c/o Booth Building, Longworth Avenue, Wallsend 2287 NSW
Country 57646 0
Australia
Phone 57646 0
+612 49246567
Fax 57646 0
Email 57646 0
luke.wolfenden@hnehealth.nsw.gov.au
Contact person for public queries
Name 57647 0
Dr Serene (Sze Lin) Yoong
Address 57647 0
University of Newcastle, c/o Booth Building, Longworth Avenue, Wallsend 2287 NSW
Country 57647 0
Australia
Phone 57647 0
+612 4924 6122
Fax 57647 0
Email 57647 0
serene.yoong@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 57648 0
Dr Serene (Sze Lin) Yoong
Address 57648 0
University of Newcastle, c/o Booth Building, Longworth Avenue, Wallsend 2287 NSW
Country 57648 0
Australia
Phone 57648 0
+612 4924 6122
Fax 57648 0
Email 57648 0
serene.yoong@hnehealth.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary