ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

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

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Public Health

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]

Prevention

Intervention code [2]

Behaviour

Intervention code [3]

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]

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]

24 months post participant project commencement date.

Primary outcome [2]

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]

Baseline: At project commencement. and 6 and 12 months (primary timepoint) of exposure to intervention

Secondary outcome [1]

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]

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]

Port Macquarie Base Hospital - Port Macquarie

Recruitment hospital [2]

Coffs Harbour Base Hospital - Coffs Harbour

Recruitment hospital [3]

Kempsey District Hospital - Kempsey

Recruitment hospital [4]

Macksville District Hospital - Macksville

Recruitment postcode(s) [1]

2444 - Port Macquarie

Recruitment postcode(s) [2]

2450 - Coffs Harbour

Recruitment postcode(s) [3]

2440 - Kempsey

Recruitment postcode(s) [4]

2447 - Macksville

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Mid North Coast Local Health District

Address [1]

Port Macquarie Community Health Centre
Morton St,
Port Macquarie
NSW 2444

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

North Coast NSW Human Research Ethics Committee

Ethics committee address [1]

Murwillumbah District Hospital 
PO Box 821 MURWILLUMBAH 
NSW 2484

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/10/2017

Approval date [1]

04/12/2017

Ethics approval number [1]

LNR179

Ethics committee name [2]

'The University of Newcastle Human Research Ethics Committee

Ethics committee address [2]

Research & Innovation Services
Research Integrity Unit
The University of Newcastle
Callaghan 
NSW 2308

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

23/09/2020

Approval date [2]

20/10/2020

Ethics approval number [2]

H-2020-0368

Summary

Brief summary

PICNIC aims to influence parents feeding practices and infant/child quality. The PICNIC study is a peer education model with peer educators supported by a website and social media. New parents with an infant aged 0-2 living on the Mid North Coast of NSW who consent to the project will receive an intervention over 12 months including online workshops, discussion groups, participant forums, and social media messaging, in view of on-sharing feeding information within their social and family networks. This study will use a progressive recruitment strategy within health services, through previous participants and online. 

Parents feeding practices will be measured when they start the project then again at 6 and 12 months to measure any changes. Parents feeding practices at 12 months will be compared with population data. Participants will complete a diet survey at 24 months after they first participated in the study and this will be compared against population data. 

Participants will work together with the research team (participatory action research) to guide ongoing intervention characteristics, to ensure modification and adaptation of the project model in partnership, consideration of participant and group characteristics. Over the intervention period the research team will provide opportunities for networking, consultation and input into all aspects of the program. Data will be collected in a number of methods including focus groups, participant correspondence, including social media forum activity.

Trial website

www.picnicproject.com.au

Trial related presentations / publications

Public notes

The following papers provide information on the pilot study describing the feasibility of parent peer-education to disseminate nutrition and feeding information, the overarching study protocol and the co-design of the intervention and research methods using Participatory Action Research.

Ball R, Duncanson K, Burrows T, Collins C. Experiences of Parent Peer Nutrition Educators Sharing Child Feeding and Nutrition Information. Children (Basel). 2017 Aug 29;4(9):78. doi: 10.3390/children4090078. PMID: 28850096; PMCID: PMC5615268.

Ball R, Duncanson K, Ashton L, Bailey A, Burrows TL, Whiteford G, Henström M, Gerathy R, Walton A, Wehlow J, Collins CE. Engaging New Parents in the Development of a Peer Nutrition Education Model Using Participatory Action Research. Int J Environ Res Public Health. 2021 Dec 23;19(1):102. doi: 10.3390/ijerph19010102. PMID: 35010363; PMCID: PMC8750105.

Ball 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.

Contacts

Principal investigator

Name

Mr Richard Ball

Address

Port Macquarie Community Health
Morton Street
Port Macquarie
NSW 2444

Country

Australia

Phone

+61 467003875

Fax

richard.ball@health.nsw.gov.au

Contact person for public queries

Name

Richard Ball

Address

Port Macquarie Community Health
Morton Street
Port Macquarie
NSW 2444

Country

Australia

Phone

+61 467003875

Fax

richard.ball@health.nsw.gov.au

Contact person for scientific queries

Name

Richard Ball

Address

Port Macquarie Community Health
Morton Street
Port Macquarie
NSW 2444

Country

Australia

Phone

+61 467003875

Fax

richard.ball@health.nsw.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
14791	Study protocol	Ball 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/	richard.ball@health.nsw.gov.au

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	Online reach and engagement of a child nutrition peer-education program (PICNIC): insights from social media and web analytics.	2022	https://dx.doi.org/10.1186/s12889-022-13252-3

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

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically