ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12615001032549

Ethics application status

Approved

Date submitted

4/09/2015

Date registered

1/10/2015

Date last updated

18/10/2018

Type of registration

Prospectively registered

Titles & IDs

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.

Secondary ID [1]

NIL

Universal Trial Number (UTN)

NIL

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Childhood overweight and obesity

Condition category

Condition code

Public Health

Health promotion/education

Diet and Nutrition

Obesity

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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 then distribute the feedback to intervention services.

5. Securing executive support: A memorandum of understanding (MOU) will be signed by the implementation support officer, the service manager and the service cook. Intervention service managers will be encouraged provide support and endorse the adherence of nutrition guidelines to all other staff within their service.

Intervention code [1]

Prevention

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]

Change in proportion of services who have a two week menu that is compliant with nutrition guidelines (provides 50% of children’s RDI)

Timepoint [1]

At baseline and at the end of the intervention period (approximately 6-months post-baseline)

Primary outcome [2]

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.

Timepoint [2]

At baseline, at the end of the intervention period (approximately 6-months post baseline) and 6 months post intervention (12 months post-baseline).

Secondary outcome [1]

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).

Timepoint [1]

At baseline and at the end of the intervention period (6-months post-baseline)

Secondary outcome [2]

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.

Timepoint [2]

End of intervention period (6-months post-baseline)

Secondary outcome [3]

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

Timepoint [3]

End of intervention (6-months post-baseline)

Secondary outcome [4]

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.

Timepoint [4]

End of intervention (6-months post-baseline)

Secondary outcome [5]

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

Timepoint [5]

The search will include the 12 months prior to and the 6 months during intervention delivery.

Secondary outcome [6]

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.

Timepoint [6]

End of intervention (6-months post-baseline)

Eligibility

Key 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)

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

Study design

Purpose of the study

Prevention

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 week prior to a telephone call from a research assistant requesting consent to participate in data collection. Random allocation of services to groups will occur following baseline data collection from all long day care services. Allocation to groups will be conducted by an independent research assistant, at a centralised location, using opaque sealed envelopes.

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.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

A regression model (linear or logistic depending on outcome), adjusted for baseline values of the primary trial outcome will be used to examine changes in the primary and secondary outcomes.

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

4/11/2016

Actual

4/11/2017

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment postcode(s) [1]

2265 - Cooranbong

Recruitment postcode(s) [2]

2265 - Martinsville

Recruitment postcode(s) [3]

2267 - Wangi Wangi

Recruitment postcode(s) [4]

2278 - Barnsley

Recruitment postcode(s) [5]

2278 - Killingworth

Recruitment postcode(s) [6]

2278 - Wakefield

Recruitment postcode(s) [7]

2280 - Belmont South

Recruitment postcode(s) [8]

2280 - Belmont

Recruitment postcode(s) [9]

2280 - Belmont North

Recruitment postcode(s) [10]

2280 - Croudace Bay

Recruitment postcode(s) [11]

2280 - Floraville

Recruitment postcode(s) [12]

2280 - Jewells

Recruitment postcode(s) [13]

2280 - Marks Point

Recruitment postcode(s) [14]

2281 - Blacksmiths

Recruitment postcode(s) [15]

2281 - Cams Wharf

Recruitment postcode(s) [16]

2281 - Catherine Hill Bay

Recruitment postcode(s) [17]

2280 - Valentine

Recruitment postcode(s) [18]

2281 - Caves Beach

Recruitment postcode(s) [19]

2281 - Little Pelican

Recruitment postcode(s) [20]

2281 - Middle Camp

Recruitment postcode(s) [21]

2281 - Murrays Beach

Recruitment postcode(s) [22]

2281 - Nords Wharf

Recruitment postcode(s) [23]

2281 - Pelican

Recruitment postcode(s) [24]

2281 - Pinny Beach

Recruitment postcode(s) [25]

2281 - Swansea

Recruitment postcode(s) [26]

2281 - Swansea Heads

Recruitment postcode(s) [27]

2282 - Eleebana

Recruitment postcode(s) [28]

2282 - Lakelands

Recruitment postcode(s) [29]

2282 - Warners Bay

Recruitment postcode(s) [30]

2283 - Arcadia Vale

Recruitment postcode(s) [31]

2283 - Awaba

Recruitment postcode(s) [32]

2283 - Balmoral

Recruitment postcode(s) [33]

2283 - Blackalls Park

Recruitment postcode(s) [34]

2283 - Bolton Point

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2283 - Buttaba

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2283 - Carey Bay

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2283 - Coal Point

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2283 - Fassifern

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2283 - Fennell Bay

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2283 - Fishing Point

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2283 - Kilaben Bay

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2283 - Rathmines

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2283 - Ryhope

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2283 - Toronto

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2284 - Argenton

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2284 - Boolaroo

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2284 - Booragul

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2284 - Speers Point

Recruitment postcode(s) [49]

2284 - Marmong Point

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2284 - Teralba

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2284 - Woodrising

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2285 - Cameron Park

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2285 - Cardiff

Recruitment postcode(s) [54]

2285 - Cardiff Heights

Recruitment postcode(s) [55]

2285 - Cardiff South

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2285 - Edgeworth

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2285 - Glendale

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2285 - Macquarie Hills

Recruitment postcode(s) [59]

2286 - Holmesville

Recruitment postcode(s) [60]

2286 - Seahampton

Recruitment postcode(s) [61]

2286 - West Wallsend

Recruitment postcode(s) [62]

2287 - Birmingham Gardens

Recruitment postcode(s) [63]

2287 - Elermore Vale

Recruitment postcode(s) [64]

2287 - Fletcher

Recruitment postcode(s) [65]

2287 - Maryland

Recruitment postcode(s) [66]

2287 - Minmi

Recruitment postcode(s) [67]

2287 - Rankin Park

Recruitment postcode(s) [68]

2287 - Summer Hill

Recruitment postcode(s) [69]

2287 - Wallsend

Recruitment postcode(s) [70]

2287 - Wallsend South

Recruitment postcode(s) [71]

2289 - Adamstown

Recruitment postcode(s) [72]

2289 - Adamstown Heights

Recruitment postcode(s) [73]

2289 - Garden Suburb

Recruitment postcode(s) [74]

2289 - Highfields

Recruitment postcode(s) [75]

2289 - Kotara

Recruitment postcode(s) [76]

2289 - Kotara Fair

Recruitment postcode(s) [77]

2289 - Kotara South

Recruitment postcode(s) [78]

2290 - Bennetts Green

Recruitment postcode(s) [79]

2290 - Charlestown

Recruitment postcode(s) [80]

2290 - Dudley

Recruitment postcode(s) [81]

2290 - Gateshead

Recruitment postcode(s) [82]

2290 - Hillsborough

Recruitment postcode(s) [83]

2290 - Kahibah

Recruitment postcode(s) [84]

2290 - Mount Hutton

Recruitment postcode(s) [85]

2290 - Redhead

Recruitment postcode(s) [86]

2290 - Tingira Heights

Recruitment postcode(s) [87]

2290 - Whitebridge

Recruitment postcode(s) [88]

2291 - Merewether

Recruitment postcode(s) [89]

2291 - Merewether Heights

Recruitment postcode(s) [90]

2291 - The Junction

Recruitment postcode(s) [91]

2292 - Broadmeadow

Recruitment postcode(s) [92]

2292 - Hamilton North

Recruitment postcode(s) [93]

2293 - Maryville

Recruitment postcode(s) [94]

2293 - Wickham

Recruitment postcode(s) [95]

2294 - Carrington

Recruitment postcode(s) [96]

2295 - Fern Bay

Recruitment postcode(s) [97]

2295 - Stockton

Recruitment postcode(s) [98]

2296 - Islington

Recruitment postcode(s) [99]

2297 - Tighes Hill

Recruitment postcode(s) [100]

2298 - Georgetown

Recruitment postcode(s) [101]

2298 - Waratah

Recruitment postcode(s) [102]

2298 - Waratah West

Recruitment postcode(s) [103]

2299 - Jesmond

Recruitment postcode(s) [104]

2299 - Lambton

Recruitment postcode(s) [105]

2299 - North Lambton

Recruitment postcode(s) [106]

2300 - Bar Beach

Recruitment postcode(s) [107]

2300 - Cooks Hill

Recruitment postcode(s) [108]

2300 - Newcastle

Recruitment postcode(s) [109]

2300 - Newcastle East

Recruitment postcode(s) [110]

2300 - The Hill

Recruitment postcode(s) [111]

2302 - Newcastle West

Recruitment postcode(s) [112]

2303 - Hamilton

Recruitment postcode(s) [113]

2303 - Hamilton East

Recruitment postcode(s) [114]

2303 - Hamilton South

Recruitment postcode(s) [115]

2304 - Kooragang

Recruitment postcode(s) [116]

2304 - Mayfield

Recruitment postcode(s) [117]

2304 - Mayfield East

Recruitment postcode(s) [118]

2304 - Mayfield North

Recruitment postcode(s) [119]

2304 - Mayfield West

Recruitment postcode(s) [120]

2304 - Sandgate

Recruitment postcode(s) [121]

2304 - Warabrook

Recruitment postcode(s) [122]

2305 - Kotara East

Recruitment postcode(s) [123]

2305 - New Lambton

Recruitment postcode(s) [124]

2305 - New Lambton Heights

Recruitment postcode(s) [125]

2306 - Windale

Recruitment postcode(s) [126]

2307 - Shortland

Recruitment postcode(s) [127]

2308 - Callaghan

Recruitment postcode(s) [128]

2308 - Newcastle University

Recruitment postcode(s) [129]

2309 - Dangar

Recruitment postcode(s) [130]

2312 - Minimbah

Recruitment postcode(s) [131]

2312 - Nabiac

Recruitment postcode(s) [132]

2314 - Williamtown Raaf

Recruitment postcode(s) [133]

2315 - Corlette

Recruitment postcode(s) [134]

2315 - Fingal Bay

Recruitment postcode(s) [135]

2315 - Nelson Bay

Recruitment postcode(s) [136]

2315 - Shoal Bay

Recruitment postcode(s) [137]

2316 - Anna Bay

Recruitment postcode(s) [138]

2316 - Boat Harbour

Recruitment postcode(s) [139]

2316 - Bobs Farm

Recruitment postcode(s) [140]

2316 - Fishermans Bay

Recruitment postcode(s) [141]

2316 - One Mile

Recruitment postcode(s) [142]

2316 - Taylors Beach

Recruitment postcode(s) [143]

2317 - Salamander Bay

Recruitment postcode(s) [144]

2317 - Soldiers Point

Recruitment postcode(s) [145]

2318 - Campvale

Recruitment postcode(s) [146]

2318 - Ferodale

Recruitment postcode(s) [147]

2318 - Fullerton Cove

Recruitment postcode(s) [148]

2318 - Medowie

Recruitment postcode(s) [149]

2318 - Oyster Cove

Recruitment postcode(s) [150]

2318 - Salt Ash

Recruitment postcode(s) [151]

2318 - Williamtown

Recruitment postcode(s) [152]

2319 - Lemon Tree Passage

Recruitment postcode(s) [153]

2319 - Mallabula

Recruitment postcode(s) [154]

2319 - Tanilba Bay

Recruitment postcode(s) [155]

2319 - Tilligerry Creek

Recruitment postcode(s) [156]

2264 - Bonnells Bay

Recruitment postcode(s) [157]

2320 - Aberglasslyn

Recruitment postcode(s) [158]

2320 - Bolwarra

Recruitment postcode(s) [159]

2320 - Bolwarra Heights

Recruitment postcode(s) [160]

2320 - Maitland

Recruitment postcode(s) [161]

2320 - Lorn

Recruitment postcode(s) [162]

2320 - Maitland North

Recruitment postcode(s) [163]

2320 - Louth Park

Recruitment postcode(s) [164]

2320 - Maitland Vale

Recruitment postcode(s) [165]

2320 - South Maitland

Recruitment postcode(s) [166]

2320 - Rutherford

Recruitment postcode(s) [167]

2320 - Telarah

Recruitment postcode(s) [168]

2320 - Pokolbin

Recruitment postcode(s) [169]

2320 - Rothbury

Recruitment postcode(s) [170]

2322 - Beresfield

Recruitment postcode(s) [171]

2322 - Black Hill

Recruitment postcode(s) [172]

2322 - Chisholm

Recruitment postcode(s) [173]

2322 - Hexham

Recruitment postcode(s) [174]

2322 - Stockrington

Recruitment postcode(s) [175]

2322 - Tarro

Recruitment postcode(s) [176]

2322 - Thornton

Recruitment postcode(s) [177]

2322 - Woodberry

Recruitment postcode(s) [178]

2322 - Tomago

Recruitment postcode(s) [179]

2322 - Lenaghan

Recruitment postcode(s) [180]

2323 - Ashtonfield

Recruitment postcode(s) [181]

2323 - Brunkerville

Recruitment postcode(s) [182]

2323 - East Maitland

Recruitment postcode(s) [183]

2323 - Green Hills

Recruitment postcode(s) [184]

2323 - Metford

Recruitment postcode(s) [185]

2323 - Metford Dc

Recruitment postcode(s) [186]

2323 - Tenambit

Recruitment postcode(s) [187]

2324 - Brandy Hill

Recruitment postcode(s) [188]

2324 - East Seaham

Recruitment postcode(s) [189]

2324 - Heatherbrae

Recruitment postcode(s) [190]

2324 - Raymond Terrace

Recruitment postcode(s) [191]

2324 - Raymond Terrace East

Recruitment postcode(s) [192]

2324 - Seaham

Recruitment postcode(s) [193]

2324 - Karuah

Recruitment postcode(s) [194]

2325 - Cessnock

Recruitment postcode(s) [195]

2325 - Cessnock West

Recruitment postcode(s) [196]

2325 - Aberdare

Recruitment postcode(s) [197]

2326 - Abermain

Recruitment postcode(s) [198]

2327 - Kurri Kurri

Recruitment postcode(s) [199]

2327 - Pelaw Main

Recruitment postcode(s) [200]

2327 - Stanford Merthyr

Recruitment postcode(s) [201]

2330 - Singleton

Recruitment postcode(s) [202]

2330 - Singleton Heights

Recruitment postcode(s) [203]

2333 - Muswellbrook

Recruitment postcode(s) [204]

2334 - Greta

Recruitment postcode(s) [205]

2420 - Dungog

Recruitment postcode(s) [206]

2428 - Tuncurry

Recruitment postcode(s) [207]

2428 - Forster

Recruitment postcode(s) [208]

2428 - Elizabeth Beach

Recruitment postcode(s) [209]

2428 - Pacific Palms

Recruitment postcode(s) [210]

2261 - The Entrance

Recruitment postcode(s) [211]

2264 - Morisset

Recruitment postcode(s) [212]

2264 - Dora Creek

Recruitment postcode(s) [213]

2340 - Tamworth

Recruitment postcode(s) [214]

2370 - Glen Innes

Recruitment postcode(s) [215]

2390 - Narrabri

Recruitment postcode(s) [216]

2430 - Taree

Recruitment postcode(s) [217]

2430 - Old Bar

Recruitment postcode(s) [218]

2350 - Armidale

Recruitment postcode(s) [219]

2360 - Inverell

Recruitment postcode(s) [220]

2400 - Moree

Recruitment postcode(s) [221]

2429 - Wingham

Recruitment postcode(s) [222]

2380 - Gunnedah

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Hunter New England Population Health

Address [1]

Longworth Avenue, Wallsend, NSW 2287

Country [1]

Australia

Funding source category [2]

University

Name [2]

University of Newcastle

Address [2]

University Drive, Callaghan NSW 2308

Country [2]

Australia

Primary sponsor type

Government body

Name

Hunter New England Population Health

Address

Longworth Avenue, Wallsend, NSW 2287

Country

Australia

Secondary sponsor category [1]

University

Name [1]

University of Newcastle

Address [1]

University Drive, Callaghan NSW 2308

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hunter New England Human Research Ethics Committee

Ethics committee address [1]

Hunter New England Health
Locked Bag 1, New Lambton NSW 2305

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/09/2015

Approval date [1]

24/09/2015

Ethics approval number [1]

(06/07/26/4.04)

Summary

Brief summary

Childcare centres represent a promising setting for interventions to improve the dietary behaviours of children as they provide broad reach to a large number of children and opportunities to be exposed to a range of nutrition promoting practices. While nutrition guidelines recommend that childcare centres provides food consistent with dietary guidelines, the impact of improving childcare food service environment on children’s diet in care has not been previously quantified. Previous childcare-based interventions have largely examined the modification of food environments in conjunction with other components which limits the ability to assess the isolated impact of improving food environment and availability on child behaviour. This study aims to assess the effect of an intervention to improve childcare service menus to comply with National nutrition guidelines. The intervention will target childcare service managers and cooks. We hypothesise the intervention will positively impact on service menus and child food intake.

Trial website

Trial related presentations / publications

Seward K, Wolfenden L, Finch M, et al. Multistrategy childcare-based intervention to improve compliance with nutrition guidelines versus usual care in long day care services: a study protocol for a randomised controlled trial. BMJ Open 2016;6:e010786. doi:10.1136/bmjopen-2015- 010786

Public notes

Attachments [1]

/AnzctrAttachments/369255-Seward 2016.pdf (Protocol)

Contacts

Principal investigator

Name

Dr Sze Lin (Serene) Yoong

Address

Heart Foundation Postdoctoral Fellowship
University of Newcastle
School of Medicine and Pubic Health
c/o Hunter New England Population Health
Locked Bag No. 10
Wallsend NSW 2287

Country

Australia

Phone

+61 2 40420649

Fax

+61 2 40420044

[email protected]

Contact person for public queries

Name

Kirsty Seward

Address

Hunter New England Population Health
Locked Bag 10
Wallsend, New South Wales 2287

Country

Australia

Phone

+61 2 4924 6565

Fax

+61 2 4924 6215

[email protected]

Contact person for scientific queries

Name

Kirsty Seward

Address

Hunter New England Population Health
Locked Bag 10
Wallsend, New South Wales 2287

Country

Australia

Phone

+61 2 4924 6565

Fax

+61 2 4924 6215

[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

Source	Title	Year of Publication	DOI
Embase	The Impact of a Childcare Food Service Intervention on Child Dietary Intake in Care: An Exploratory Cluster Randomized Controlled Trial.	2019	https://dx.doi.org/10.1177/0890117119837461

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically