Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000576527
Ethics application status
Approved
Date submitted
4/04/2024
Date registered
7/05/2024
Date last updated
7/05/2024
Date data sharing statement initially provided
7/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The Tiny Bites program – testing the impact of a digital intervention to support parents and childcare services with healthier diets in children aged < 2 years.
Scientific title
The Tiny Bites program – a randomised controlled trial assessing the impact of a digital intervention to support parents and childcare services with healthier diets in children aged < 2 years.
Secondary ID [1] 311880 0
MRF2022883
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 333445 0
Infant feeding 333446 0
Condition category
Condition code
Diet and Nutrition 330120 330120 0 0
Obesity
Public Health 330121 330121 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Tiny Bites program is a primarily digital intervention that supports early childhood education and care (ECEC) services and primary caregivers of children aged <2 years with improving child nutrition, Tiny Bites will be delivered across approximately 18 months.

Strategies for ECEC services include:
-Participate in an initial educational outreach visit and support calls from a Health Promotion Officer throughout the duration of the intervention (educational outreach and facilitation). A health promotion officer located with the Local Health District will reach out via telephone to schedule the initial visit and any follow up calls at a time that is convenient to the service. These contacts could be conducted face to face, online or via the phone.
- The service supervisor will complete the web-based Tiny Bites self-assessment (approximately 15 minutes) and this will automatically generate a suggested action plan for implementation (self-assessment and action planning)
-Educators will be invited to participate in free training which will be delivered through pre-recorded (and live) 6 x 15-minute self-paced webinar modules covering infant feeding and responsive feeding practices and 1 x 20-minute self-paced webinar module covering nutrition conversations with primary caregivers, professionally presented by experts in the field of infant nutrition and communication (online professional development)
-Services will be asked to appoint an Infant Nutrition Champion (an educator in the infant room)

The strategies will support ECECs with:
- Updating policy and procedures around responsive feeding practices and infant feeding, including ongoing breastfeeding (where appropriate)
- Distributing bi-monthly online or paper communication to primary caregivers (approximately 9 over 18 months) using provided templates, which reinforce key themes from text messages and how the service supports these behaviours through their primary caregiver communication system
- Displaying physical resources including posters, stickers and flipcharts designed to remind educators about implementing best practice infant feeding and responsive feeding practices and to act as prompts to facilitate nutrition conversations with primary caregivers.
To assess adherence, the health promotion team will track number of contacts and what was delivered in each session. To maximise adherence, multiple contacts and flexible delivery modalities will be offered to ECECs. We will gather online analytics to monitor completion of webinars and use of the online elements..

Primary caregivers will receive:
-Regular text messages (approximately weekly to fortnightly throughout the 18-month period). These messages will be broadly tailored to child developmental milestones and will be one-way messages.
- Monthly/bi-monthly digital newsletters summarising resources and text messages (these newsletters will also be delivered to nominated individuals who may be involved in feeding children, such as grandparents/extended family members).
- A number of communications from the ECEC service will be distributed to primary caregivers which reinforce key themes from text messages and describes how the service is supporting these behaviours. These may vary from centre to centre.
- Access to a webpage with a collection of infant feeding and responsive feeding digital resources. Some text messages and digital newsletters will include links that direct parents to this webpage and/or specific resources.
- Access to infant feeding and responsive feeding webinars developed by experts via links in the text messages. This will be recorded versions hosted on the Tiny Bites program. This will be similar to that accessed by the childcare providers in terms of length and duration.

We will collect data related to parent opening of text messages and accessing links using online analytics. We are not able to access individual parents accessing of the webinars however will monitor the number clicking on the link to the online recording.
Intervention code [1] 328346 0
Prevention
Intervention code [2] 328347 0
Behaviour
Comparator / control treatment
ECEC services and primary caregivers allocated to the control group will receive usual care. For ECEC services, this includes general support from health promotion teams upon request to implement the state-funded obesity prevention program. For primary caregivers this includes access to usual child and family health sites and government resources and links to infant feeding guidelines.
Control group
Active

Outcomes
Primary outcome [1] 337878 0
Child BMI zscore
Timepoint [1] 337878 0
Baseline and post-intervention (approximately 18 months)
Secondary outcome [1] 433572 0
Duration child received breastmilk
Timepoint [1] 433572 0
Baseline and post-intervention (approximately 18 months)
Secondary outcome [2] 433573 0
Child variety and frequency of fruit and vegetable consumption
Timepoint [2] 433573 0
Baseline and post-intervention (approximately 18 months)
Secondary outcome [3] 433574 0
Child frequency of consuming discretionary foods
Timepoint [3] 433574 0
Baseline and post-intervention (approximately 18 months)
Secondary outcome [4] 433575 0
Primary caregiver use of persuasive feeding behaviours
Timepoint [4] 433575 0
Baseline and post-intervention (approximately 18 months)
Secondary outcome [5] 433616 0
Primary caregiver reported adverse events
Timepoint [5] 433616 0
Baseline and post-intervention (18 months)
Secondary outcome [6] 434386 0
Serves of vegetable consumed by child
Timepoint [6] 434386 0
Baseline and post-intervention (approximately 18 months)
Secondary outcome [7] 434387 0
Child consumption of sugar sweetened beverages
Timepoint [7] 434387 0
Baseline and post-intervention (approximately 18 months)
Secondary outcome [8] 434388 0
Primary caregiver using (non-)food rewards for child in the home environment
Timepoint [8] 434388 0
Baseline and post-intervention (approximately 18 months)
Secondary outcome [9] 434526 0
Serves of fruit consumed by child
Timepoint [9] 434526 0
This will be based of validated measures from the short Food Frequency Questionnaire (Flood 2013) and will be used to capture data the number of serves of fruits consumed.

Eligibility
Key inclusion criteria
ECEC services will be eligible if: i) they enrol at least 5 children aged 4-12 months (inclusive) ii) have internet access and iii) are located in areas where an existing text messaging service has not been rolled out (Healthy Beginnings for HNE Kids).

Children will be eligible if they: i) are aged 4- 12 months (inclusive) at recruitment; ii) are present at the ECEC services during the week of recruitment and, iii) have primary caregiver consent. Families with more than one child of the same age (i.e. twins, triplets) will be included if they meet the eligibility criteria.

Primary caregivers of eligible children will be eligible to participate if i) they have a mobile phone with web capabilities (e.g. 4G/5G) and ii) can understand English sufficiently to engage with the intervention.
Minimum age
4 Months
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Mobile services, family-based day care, occasional care services, Department of Education services and services who cater exclusively for children requiring specialist care will be excluded, as will services involved in trials conducted by the research team in the past two years.

Children with diagnosed medical conditions that influence their ability to consume foods in line with the Australian Dietary Guidelines will be excluded.

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)
Services will be randomly assigned, following all service baseline data collection, An independent statistician will generate the randomisation schedule and this will be centrally allocated (and concealed) following baseline data collection. Following random allocation, services will be notified of their group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Services will be randomly assigned to the intervention or to a usual care control group in a 1:1 ratio. Randomisation will be stratified by socioeconomic status (SES) based on Socio-Economic Indexes For Areas (SEIFA) classifications using the ECEC service postcode, given the association of SES with primary outcomes. We will also use block randomisation (2, 4 or 6) to ensure group allocation is approximately equal. The sample will also be stratified to ensure services with a high proportion of Aboriginal and Torres Strait Islander child enrolments (>10%) will be assigned to the intervention or control group in a 1:1 ratio.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on previous studies, the standard deviation is approximately 1.0 and mean BMI z-score is approximately 0.41. To detect an absolute difference of 0.26 in BMI z-score (considered clinically significant at a population level with 80% power and two-sided 5% significance level and intracluster correlation coefficient (ICC) of 0.02, a sample size of 270 per group (540 total, approximately 60 clusters of 9 dyads) will be recruited. As an intention-to-treat analysis will be undertaken as the main analysis (participants analysed according to the group as randomised), we have not accounted for attrition.

Consistent with best practice, the primary analyses will be undertaken under an intention-to-treat framework, using multiple imputation to account for missing data. For the primary outcome, between-group differences will be assessed for paired data using 2-level hierarchical linear regression models (for continuous data). Models will be adjusted for services-level clustering through a random effect and controlled for baseline measures and service’s SES.

To assess differences between groups for secondary outcomes, linear regression analyses will be conducted (for continuous outcomes). Models will be adjusted for services-level clustering and any stratified variables through a random effect and controlled for baseline measures.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/07/2024
Actual
Date of last participant enrolment
Anticipated
31/10/2024
Actual
Date of last data collection
Anticipated
29/01/2027
Actual
Sample size
Target
540
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 42455 0
2312 - Nabiac
Recruitment postcode(s) [2] 42457 0
2320 - Rutherford
Recruitment postcode(s) [3] 42458 0
2320 - Maitland
Recruitment postcode(s) [4] 42459 0
2320 - Bolwarra
Recruitment postcode(s) [5] 42477 0
2320 - Aberglasslyn
Recruitment postcode(s) [6] 42478 0
2321 - Gillieston Heights
Recruitment postcode(s) [7] 42479 0
2321 - Morpeth
Recruitment postcode(s) [8] 42480 0
2322 - Chisholm
Recruitment postcode(s) [9] 42481 0
2322 - Thornton
Recruitment postcode(s) [10] 42482 0
2323 - Ashtonfield
Recruitment postcode(s) [11] 42483 0
2323 - East Maitland
Recruitment postcode(s) [12] 42484 0
2323 - Metford
Recruitment postcode(s) [13] 42485 0
2324 - Tea Gardens
Recruitment postcode(s) [14] 42486 0
2325 - Cessnock
Recruitment postcode(s) [15] 42487 0
2325 - Nulkaba
Recruitment postcode(s) [16] 42488 0
2327 - Kurri Kurri
Recruitment postcode(s) [17] 42489 0
2328 - Denman
Recruitment postcode(s) [18] 42490 0
2330 - Singleton
Recruitment postcode(s) [19] 42491 0
2333 - Muswellbrook
Recruitment postcode(s) [20] 42492 0
2334 - Greta
Recruitment postcode(s) [21] 42493 0
2335 - Branxton
Recruitment postcode(s) [22] 42494 0
2340 - Hillvue
Recruitment postcode(s) [23] 42495 0
2340 - South Tamworth
Recruitment postcode(s) [24] 42496 0
2340 - Taminda
Recruitment postcode(s) [25] 42497 0
2340 - Tamworth
Recruitment postcode(s) [26] 42498 0
2340 - North Tamworth
Recruitment postcode(s) [27] 42499 0
2340 - Tamworth South
Recruitment postcode(s) [28] 42500 0
2340 - West Tamworth
Recruitment postcode(s) [29] 42501 0
2340 - Westdale
Recruitment postcode(s) [30] 42502 0
2343 - Quirindi
Recruitment postcode(s) [31] 42503 0
2350 - Armidale
Recruitment postcode(s) [32] 42504 0
2354 - Walcha
Recruitment postcode(s) [33] 42505 0
2358 - Uralla
Recruitment postcode(s) [34] 42506 0
2360 - Inverell
Recruitment postcode(s) [35] 42507 0
2365 - Guyra
Recruitment postcode(s) [36] 42508 0
2370 - Glen Innes
Recruitment postcode(s) [37] 42509 0
2372 - Tenterfield
Recruitment postcode(s) [38] 42510 0
2380 - Gunnedah
Recruitment postcode(s) [39] 42511 0
2382 - Boggabri
Recruitment postcode(s) [40] 42512 0
2388 - Wee Waa
Recruitment postcode(s) [41] 42513 0
2390 - Narrabri
Recruitment postcode(s) [42] 42514 0
2400 - Moree
Recruitment postcode(s) [43] 42515 0
2420 - Dungog
Recruitment postcode(s) [44] 42516 0
2422 - Gloucester
Recruitment postcode(s) [45] 42517 0
2427 - Harrington
Recruitment postcode(s) [46] 42518 0
2428 - Forster
Recruitment postcode(s) [47] 42519 0
2428 - Pacific Palms
Recruitment postcode(s) [48] 42520 0
2428 - Smiths Lake
Recruitment postcode(s) [49] 42521 0
2428 - Tuncurry
Recruitment postcode(s) [50] 42522 0
2429 - Wingham
Recruitment postcode(s) [51] 42523 0
2430 - Chatham
Recruitment postcode(s) [52] 42524 0
2430 - Diamond Beach
Recruitment postcode(s) [53] 42525 0
2430 - Old Bar
Recruitment postcode(s) [54] 42526 0
2430 - Taree
Recruitment postcode(s) [55] 42527 0
2430 - Tinonee
Recruitment postcode(s) [56] 42528 0
2321 - Lochinvar

Funding & Sponsors
Funding source category [1] 316227 0
Government body
Name [1] 316227 0
National Health and Medical Research Council
Country [1] 316227 0
Australia
Funding source category [2] 316231 0
Government body
Name [2] 316231 0
Hunter New England Population Local Health District
Country [2] 316231 0
Australia
Funding source category [3] 316232 0
Charities/Societies/Foundations
Name [3] 316232 0
Australian Prevention Partnership Centre
Country [3] 316232 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Country
Australia
Secondary sponsor category [1] 318417 0
Government body
Name [1] 318417 0
Hunter New England Local Health District
Address [1] 318417 0
Country [1] 318417 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315046 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 315046 0
Ethics committee country [1] 315046 0
Australia
Date submitted for ethics approval [1] 315046 0
19/12/2023
Approval date [1] 315046 0
20/12/2023
Ethics approval number [1] 315046 0
2023/ETH01158

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

Contacts
Principal investigator
Name 133514 0
A/Prof Serene Yoong
Address 133514 0
Deakin University, 221 Burwood Highway, Burwood VIC 3125, Australia
Country 133514 0
Australia
Phone 133514 0
+61 3 9214 4935
Fax 133514 0
Email 133514 0
[email protected]
Contact person for public queries
Name 133515 0
A/Prof Serene Yoong
Address 133515 0
Deakin University, 221 Burwood Highway, Burwood VIC 3125, Australia
Country 133515 0
Australia
Phone 133515 0
+61 3 9214 4935
Fax 133515 0
Email 133515 0
[email protected]
Contact person for scientific queries
Name 133516 0
A/Prof Serene Yoong
Address 133516 0
Deakin University, 221 Burwood Highway, Burwood VIC 3125, Australia
Country 133516 0
Australia
Phone 133516 0
+61 3 9214 4935
Fax 133516 0
Email 133516 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Following de-identification, participant data can be made available upon request depending on nature of requested.
When will data be available (start and end dates)?
Beginning 18 months following the publication of all primary and secondary outcomes (available for 5 years after publication).
Available to whom?
Researchers who provide a methodologically sound proposal, inclusion in systematic reviews, and on a case-by-case basis at the discretion of the Principal Investigator.
Available for what types of analyses?
For any reasonable purpose, in line with ethical restrictions.
How or where can data be obtained?
The data will be stored at secured services at Deakin University. Access will be provided and is subject to approval by the Principal Investigator and can be provided via direct email of the Principal Investigator ([email protected]).


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.