Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000230752
Ethics application status
Approved
Date submitted
27/01/2022
Date registered
9/02/2022
Date last updated
7/09/2023
Date data sharing statement initially provided
9/02/2022
Date results provided
7/09/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
The PICNIC Project: New parent peer educators sharing infant and child nutrition and feeding information: A multi-strategy approach
Scientific title
Efficacy of the PICNIC Project: New parent peer educators sharing infant and child nutrition and feeding information: A multi-strategy approach
Secondary ID [1] 304820 0
NIL Known
Universal Trial Number (UTN)
Trial acronym
PICNIC: Parents In Child Nutrition Informing Community
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Poor infant/child nutrition and parent feeding practices 322886 0
Condition category
Condition code
Diet and Nutrition 320466 320466 0 0
Other diet and nutrition disorders
Public Health 322514 322514 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The PICNIC intervention is a peer to peer approach supported by an online and social media strategy. Parents with an infant aged 0-2 years will receive training support and resources on infant/child nutrition and feeding practices to on-share within their parent and social networks over 12 months.

The 12-month participant intervention consists of a number of support strategies of which the introductory workshop is the only prerequisite for study involvement and other strategies are opt-in only, at participants own discretion. Participant’s attendance and engagement with support strategies is monitored where possible. This includes attendance at participant meetings, support requests and Facebook closed group participation. Website analytics and social media page performance data is monitored and analysed, although this is inclusive of the wider parent audience outside of consenting participants.

All PICNIC intervention strategies cover:
• Introduction of Solids
• Responsive Feeding
• Australian Guide to Healthy Eating
• Food Exposure
• Division of Responsibility
• Food Rewards
• Pressure to eat
• Food Restriction
• Meal environment and structure
• Food Role Modelling
• Common Feeding issues
• Healthy Growth

A two-hour online introductory workshop is a group education session capped at 10 participants run by research team Accredited Practising Dietitians. The workshop covers nutrition and feeding content, research overview, navigation of the support strategies (website and social media), data collection and project history.

One hour participant meetings are run monthly with participants scheduled into one 4 weeks after introductory workshop with the opportunity to attend more over the 12 month intervention period. Workshops are facilitated by an Accredited Practising Dietitian from the research team and discussion/topics are driven by participants.

Participants are encouraged to join the Facebook Closed Group, a forum for questions and discussion, to provide participant updates and receive feeding nutrition/messages posted 4-5 times per week developed by research team Accredited Practising Dietitians.

Participants are encouraged to follow the open Facebook and Instagram support pages and to circulate to their social circles. 4 - 5 feeding/nutrition messages each week developed by research team Accredited Practising Dietitians.

A project content website has been developed to support participants and other parents within participants’ social networks, with nutrition and feeding content. In the co-design of the intervention parents requested an online repository of project information. The website contains text, video and images which parents navigate on their terms.
Intervention code [1] 321188 0
Prevention
Intervention code [2] 322693 0
Behaviour
Intervention code [3] 322694 0
Lifestyle
Comparator / control treatment
Intervention data will be compared with historical population data from respondents voluntarily completing the Heathy Eating Quiz for pre-schoolers, collected online from July 2019 to present.

Burrows TL, Collins K, Watson JF, Guest M, Boggess MM, Hutchesson MJ, Rollo M, Duncanson K, Collins CE. Validity of the Australian Recommended Food Score as a diet quality index for Preschoolers. Nutrition Journal 014, 13:87.
.
Control group
Historical

Outcomes
Primary outcome [1] 328299 0
Infant/child diet quality. The Australian Recommended Food Scores for Pre-Schoolers
(ARFS-P): A paediatric diet quality index measure validated for use in children aged two to five years.
Validated measure: Burrows, T.L., Collins, K., Watson, J., Guest, M., Boggess, M.M., Neve, M., Rollo, M., Duncanson, K. and Collins, C.E., 2014. Validity of the Australian Recommended Food Score as a diet quality index for Pre-schoolers. Nutrition journal, 13(1), pp.1-10.
Timepoint [1] 328299 0
24 months post participant project commencement date.
Primary outcome [2] 330236 0
Parent Feeding Practice constructs: Using the Feeding Practices and Structure Questionnaire (Infant and solids version): Demand vs. routine; Structured meal timing;
Sit down meals; Family meal environment; Role modelling; Division of responsibility
Trust; Pressure to eat; Food to calm; Food rewards
Jansen, E., Russell, C.G., Appleton, J., Byrne, R., Daniels, L.A., Fowler, C., Rossiter, C. and Mallan, K.M., 2021. The Feeding Practices and Structure Questionnaire: development and validation of age appropriate versions for infants and toddlers. International Journal of Behavioral Nutrition and Physical Activity, 18(1), pp.1-14.
Timepoint [2] 330236 0
Baseline: At project commencement. and 6 and 12 months (primary timepoint) of exposure to intervention
Secondary outcome [1] 398479 0
Seek to examine if and how a peer, education approach can improve the PICNIC study implementation model in line with the principles of research co-design.
Timepoint [1] 398479 0
Data will be consolidated monthly and discussed by project participants and the research team. After each Participatory Action Research cycle a structured content analysis will be conducted, informing the next iteration of the implementation model and research methods. Data will be collected from focus groups (Participatory Action Research Cycle 1), monthly online participant meetings, the social media forum, correspondence between the implementation team and participants and field notes.

Eligibility
Key inclusion criteria
Parents and primary carers:
- with a child aged zero to two years at the time of recruitment.
- 18 years and over.
- Live with the Mid North Coast Local Health District area, New South Wales, Australia
Minimum age
0 Months
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Parents and primary carers with only children whose nutrition/feeding are influenced by a medical condition, speech pathology, disability, who are unable to understand written and spoken English .infant aged from birth to two years, aged under 18 years live outside the Mid North Coast Local Health District.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Dietary intake analysis will include the following measures: Core food variety, overall diet quality score. These will be measured against age-matched controls at 24 months post intervention using the validated Healthy Eating Quiz. Mean values for all variables will be compared using appropriate comparative statistical tests. A sample size of at least 200 participants will be feasible for analysis of the PICNIC study within existing resources, allowing for comparison with historical data age and population matched controls and to be adequate to detect a difference in dietary intake between groups. We have conducted a power and sample size calculation as follows: 1 sample test with 80% power at 5% significance level and to detect a 4 points difference (greater or less) in ARFS (diet quality) between the historical control (ARFS = 36) we need to conduct 60 ARFS surveys of 3-years old. To detect a 2 points difference, n = 237, or for a 3-point difference, n = 106. Therefore, we will aim to conduct at least 200 ARFS surveys, which will allow for both detection of a 2 points difference and also to allow for potential stratification to be accounted for in analysis.

Changes in child feeding over time will be assessed measured by mean (SD) for the constructs of: Demand vs. routine; structured meal timing; Sit down meals; Family meal environment; Role Modelling; Division of responsibility/Trust; Pressure to eat; Food to calm; Food rewards; Restriction (Overt/Covert). Mean values for each domain will be compared over time and changes over time analysed at an individual level using appropriate interpretive statistical tests, and accounting for confounding factors where possible.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/01/2019
Date of last participant enrolment
Anticipated
30/06/2022
Actual
30/06/2022
Date of last data collection
Anticipated
1/06/2023
Actual
30/06/2022
Sample size
Target
370
Accrual to date
Final
263
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 21547 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment hospital [2] 21548 0
Coffs Harbour Base Hospital - Coffs Harbour
Recruitment hospital [3] 21549 0
Kempsey District Hospital - Kempsey
Recruitment hospital [4] 21550 0
Macksville District Hospital - Macksville
Recruitment postcode(s) [1] 36455 0
2444 - Port Macquarie
Recruitment postcode(s) [2] 36456 0
2450 - Coffs Harbour
Recruitment postcode(s) [3] 36457 0
2440 - Kempsey
Recruitment postcode(s) [4] 36458 0
2447 - Macksville

Funding & Sponsors
Funding source category [1] 309192 0
Hospital
Name [1] 309192 0
Mid North Coast Local Health District
Country [1] 309192 0
Australia
Primary sponsor type
Individual
Name
Richard Ball
Address
Port Macquarie Community Health
Morton Street
Port Macquarie
NSW 2444
Country
Australia
Secondary sponsor category [1] 311819 0
None
Name [1] 311819 0
Address [1] 311819 0
Country [1] 311819 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309047 0
North Coast NSW Human Research Ethics Committee
Ethics committee address [1] 309047 0
Ethics committee country [1] 309047 0
Australia
Date submitted for ethics approval [1] 309047 0
26/10/2017
Approval date [1] 309047 0
04/12/2017
Ethics approval number [1] 309047 0
LNR179
Ethics committee name [2] 310219 0
'The University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 310219 0
Ethics committee country [2] 310219 0
Australia
Date submitted for ethics approval [2] 310219 0
23/09/2020
Approval date [2] 310219 0
20/10/2020
Ethics approval number [2] 310219 0
H-2020-0368

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

Contacts
Principal investigator
Name 112778 0
Mr Richard Ball
Address 112778 0
Port Macquarie Community Health
Morton Street
Port Macquarie
NSW 2444
Country 112778 0
Australia
Phone 112778 0
+61 467003875
Fax 112778 0
Email 112778 0
[email protected]
Contact person for public queries
Name 112779 0
Richard Ball
Address 112779 0
Port Macquarie Community Health
Morton Street
Port Macquarie
NSW 2444
Country 112779 0
Australia
Phone 112779 0
+61 467003875
Fax 112779 0
Email 112779 0
[email protected]
Contact person for scientific queries
Name 112780 0
Richard Ball
Address 112780 0
Port Macquarie Community Health
Morton Street
Port Macquarie
NSW 2444
Country 112780 0
Australia
Phone 112780 0
+61 467003875
Fax 112780 0
Email 112780 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14791Study protocolBall R, Vaschak R, Bailey A, Whiteford G, Burrows TL, Duncanson K, Collins CE. Study Protocol of the Parents in Child Nutrition Informing Community (PICNIC) Peer Education Cohort Study to Improve Child Feeding and Dietary Intake of Children Aged Six Months to Three Years Old. Children (Basel). 2019 Dec 27;7(1):3. doi: 10.3390/children7010003. PMID: 31892113; PMCID: PMC7023363.https://pubmed.ncbi.nlm.nih.gov/31892113/[email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseOnline reach and engagement of a child nutrition peer-education program (PICNIC): insights from social media and web analytics.2022https://dx.doi.org/10.1186/s12889-022-13252-3
N.B. These documents automatically identified may not have been verified by the study sponsor.