ANZCTR - Registration

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

ACTRN12615000969561

Ethics application status

Approved

Date submitted

19/08/2015

Date registered

16/09/2015

Date last updated

4/08/2017

Type of registration

Prospectively registered

Titles & IDs

Public title

Confident and understanding parents: Child nutrition and active play intervention among highly disadvantaged families attending Supported Playgroups

Scientific title

Effectiveness of a child health intervention in Supported Playgroups for promoting parenting knowledge and confidence and improving child nutrition and active play practices among highly disadvantaged families.

Secondary ID [1]

NIL

Universal Trial Number (UTN)

NIL

Trial acronym

CUPs

Linked study record

Health condition

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

Prevention of childhood overweight and obesity

Condition category

Condition code

Public Health

Health promotion/education

Public Health

Health service research

Diet and Nutrition

Obesity

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

An incomplete step-wedge cluster randomised controlled trial, with Supported Playgroups as the unit of randomisation will be conducted with parents of young children 0 – 4 years of age attending Supported Playgroups. The trial is the third and final phase in the development of a complex intervention. A two month program will be implemented and evaluated at baseline, 10 weeks and follow up at 20 weeks. Results will be compared with control groups of matched Supported Playgroups receiving their usual programs.
Features of the intervention include:
* Delivery of six (selected from ten) evidence-based nutrition and active play messages. Discussions take no longer than 10 minutes to discuss during usual Supported Playgroups. Two example messages are: ‘play outside every day’ and ‘eat fruit and vegetables’. Six of the ten messages are selected by Facilitators based on the needs of the group, and Facilitator confidence to discuss the message. Local service providers and /or researchers assist SP Facilitators to deliver the messages
* Training program for Supported Playgroup Facilitators to deliver the program. Training is conducted by the research team as one x 6 hour session, or two x 3 hour sessions based on SP facilitator availability and includes case scenarios and mastery to build knowledge and confidence.
* A culturally competent approach using existing local capacity within Supported Playgroups to enhance usual service delivery. Facilitators will also use existing Supported Playgroup resources to discuss messages with parents. They will consider cultural needs of their groups during delivery of the messages.
* Parental empowerment; problem solving and active listening. Facilitators will select different times during the playgroup and/or different modes of discussion (whole group, small groups, one-on-one) to deliver the messages based on each group need.
* Practical focus – shopping, cooking, mealtime behaviour, active play, limit screens. Each message is presented pictorially, supported by 3-4 evidence statements (ie WHY the message is important) and 3 – 4 practical strategies (HOW families can implement the message) with considerations for developmental stage of the age group. Role modeling during Supported Playgroup will enhance practical applicability.

Consistent with the socio-ecological model of health encompassing the social determinants of health, the intervention is informed by theories of cultural competence, social learning, health belief and health literacy. This framework builds on existing strengths of parents to increase their confidence and self-efficacy. Cultural consideration is critical because many Supported Playgroups target culturally diverse families. The approach is strengthened by working with existing Supported Playgroup providers and facilitators, which will minimise the major barrier of engaging families with high needs and the other barriers such as low help-seeking behaviour, transport, social stigma, and cultural concerns.
Researchers monitor fidelity of the each of the core components. They are present during training and delivery of each session by the facilitators.

Intervention code [1]

Prevention

Intervention code [2]

Lifestyle

Intervention code [3]

Behaviour

Comparator / control treatment

Using an incomplete step-wedge design, the comparator group comprises Supported Playgroups who will receive the intervention at a later date. The comparator group continue to attend usual Supported Playgroups. This provides opportunities for parents and children to socialise with other families. This may include incidental participation in incidental activities such as talks given by guest speakers during the course of usual Supported Playgroup activities.

Control group

Active

Outcomes

Primary outcome [1]

Primary outcome:
Change in parenting self-efficacy around child nutrition and active play. Five-point Likert scale surveys adapted from a validated self-efficacy instrument will be used to assess changes in confidence of parents to promote their child’s healthy eating, limit noncore foods and encourage active play.

Timepoint [1]

Time points of data collection are T1 = Baseline (before group commencement), T2 = post (at conclusion of the intervention 10 weeks after T1) and T3 = follow up (20 weeks after T1).

Secondary outcome [1]

Child outcomes:
Composite secondary outcome:
Changes in child nutrition and active play practices.
Nutrition practice questions will be selected and modified from the most recent national child nutrition survey questionnaire (children 2 – 8 years), the Eating and Physical Activity Questionnaire and the Baby Eating Behaviour Questionnaire. Key questions refer to drinks, fruit and vegetable consumption and food security. Selected questions about physical activity, television viewing and risk in play will also be used. Parents will complete this questionnaire.

Timepoint [1]

Time points of data collection are T1 = Baseline (before group commencement), T2 = post (at conclusion of the intervention 10 weeks after T1) and T3 = follow up (20 weeks after T1).

Secondary outcome [2]

Changes in family connections to two early childhood services (Maternal and Child Health service and Kindergartens). This will be measured through usual attendance records at these services.

Timepoint [2]

Time points of data collection are T1 = Baseline (before group commencement), T2 = post (at conclusion of the intervention 10 weeks after T1) and T3 = follow up (20 weeks after T1).

Secondary outcome [3]

Process evaluation:
Members of the research team will be present throughout planning, training, and delivery of the intervention as part of an ethnographic research approach at a sample of no fewer than 12 Supported Playgroup sites.
This approach builds rapport with the SP Facilitators, parents and stakeholders. It provides in-depth opportunities for observing, listening and asking questions to gain insights into the feasibility and fidelity of the program.

Timepoint [3]

Continuous data collection during the intervention, i.e. from baseline (T = 1) to 10 weeks (T = 2).

Secondary outcome [4]

Composite secondary outcome: Facilitators
Changes in child nutrition and active play knowledge and confidence to discuss messages with families. Five-point Likert scale surveys were adapted from validated instruments to assess changes in child nutrition knowledge and confidence of SP facilitators.

Timepoint [4]

Time points of data collection are T1 = Baseline (before group commencement), T2 = post (at conclusion of the intervention 10 weeks after T1) and T3 = follow up (20 weeks after T1).

Eligibility

Key inclusion criteria

Parents/carers of young children aged 0 – 4 years attending existing early childhood services (Supported Playgroups).
Enrolment criteria for Supported Playgroups include health care card plus one of the following criteria: single parent family, Indigenous family, young parent family (<25 years), socially isolated, low income, culturally and linguistically diverse background, refugee or asylum seeker background.
All parents, independent of language spoken at home, age, education, and number of children will be eligible to participate.

Minimum age

16 Years

Maximum age

50 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

NIL

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)

Dr Tibor Schuster (Statistician at MCRI) will conduct the randomisation independently of the other researchers. The unit of randomisation is at the level of the Supported Playgroup. Supported Playgroups will be informed of the outcome of randomisation after they have given full consent to participate in the trial. As individual participants are recruited to programs offered by their nearest service, they will not be blinded to allocation at recruitment.

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

Other

Other design features

All groups receive the same intervention, although groups are wait-listed to receive the intervention at different time points through the step-wedge design.

Phase

Type of endpoint/s

Efficacy

Statistical methods / analysis

It is estimated that a total of 128 participants will be required to detect a difference between the intervention and control arms of 0.5 standard deviations from the mean desirable behaviours relating to early child nutrition and active play, with an 80% power, at a 5% level of significance. This expected effect size of 0.5 standard deviations of the mean scores on quantifiable desirable behaviour change in nutrition and active play is based on existing evidence in similar studies. However, to account for clustering among participants within a supported playgroup the Intraclass Correlation Coefficient (ICC) measure of 0.02 is used. This is considered a conservative measure in the literature, and commonly used in health behaviour change research. Assuming an average of 10 participants per supported playgroup, there is a Variation Inflation Factor (or Design Effect) of 1.2; and assuming a conservative attrition rate of 40%, it is calculated that 212 participants are required in the total sample size. This attrition rate of 40% is a conservative estimate based on the pilot program results. During the Pilot Program attrition, which was defined as failure to attend more than three sessions over 3 months, was substantially less than 40% (i.e. ~25-30%).

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/02/2018

Actual

Date of last participant enrolment

Anticipated

30/06/2020

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

212

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

Australian Catholic University

Address [1]

Locked Bag 4115 Fitzroy VIC 3065

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Windermere Foundation

Address [2]

Level 10, 530 Collins Street
Melbourne VIC 3000

Country [2]

Australia

Primary sponsor type

University

Name

Australian Catholic University

Address

Locked Bag 4115, Fitzroy, VIC 3065

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Australian Catholic University

Ethics committee address [1]

Locked Bag 4115 Fitzroy VIC 2065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

20/12/2013

Ethics approval number [1]

2013 177V

Ethics committee name [2]

Department of Education and Training

Ethics committee address [2]

GPO Box 4367 Melbourne 3001 VIC

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

31/03/2014

Ethics approval number [2]

2014_002283

Summary

Brief summary

The trial is the third phase of a complex intervention that by definition, involves large variability in a target population and is a placed-based initiative for highly vulnerable families.  
Our research is informed by a needs assessment (Phase 1) and feasibility study (Phase 2). 
We will assess the impact of child nutrition and active play advice delivered in community-based early childhood settings to vulnerable families. We will train Supported Playgroup facilitators and bicultural workers to will deliver six key messages (chosen from 10) about child health and development issues. Building on established relationships between facilitators, bicultural workers and their families, the program is delivered by facilitators in their existing Supported Playgroups using place-based resources, during one school term. 
We previously found that children attending Supported Playgroups were over-represented among those consuming sweet drinks and ‘packaged’ foods, and viewing excessive hours of television. Parents reported concerns about the safety of their children during active play and some powerlessness in providing healthy food. Supported Playgroup parents also described greater difficulties accessing, understanding, and using health information than other families in the same locations of social disadvantage.  
Our subsequent feasibility study co-designed by stakeholders demonstrated effective communication about key messages in child nutrition and active play by Supported Playgroup facilitators. More specifically, it resulted in improved knowledge and confidence of SP facilitators and parents, and changes in parenting behaviours. Although key messages in child nutrition and active play have been successfully used in early childhood interventions in Australia, culturally and linguistically diverse and significantly disadvantaged families have not participated. Innovation in effective delivery of child nutrition and active play messages is urgently required for high needs families.

Research questions
Can early childhood settings be used as a platform to convey key child health and developmental messages to parents of young children living with significant social and economic disadvantage? Can Supported Playgroup facilitators effectively communicate key messages about child nutrition and active play? How can the evidence-based knowledge be best disseminated for specific family and playgroup contexts?  What knowledge will families recall away from Supported Playgroups and will it translate into child-health practices and better connections to existing services? To this end, the general hypothesis is that when well-considered and sensitively delivered messages about child nutrition and active play are embedded into Supported Playgroups, parental knowledge will increase and child-health practices will improve. This experience will also increase the social connectedness and ultimately the self-efficacy in parenting of highly disadvantaged parents.

Specific Hypotheses
1.	That increased parental knowledge and self-efficacy about child nutrition and active play will promote improved child health-related behaviours. 
2.	That Supported Playgroups are an effective place-based setting to convey child health and development information to vulnerable families. 

Aim
Our overall research goal is to address health and social inequalities among vulnerable families with young children. 

Specifically this project aims to
1.	Improve child nutrition and active play-related behaviours in vulnerable families.
2.	Advance knowledge about effective strategies for achieving translation of the research findings into policy in early childhood settings.

The trial has not been previously registered. 
Relevant citations arising from Phase 1 are: 

Myers, J., K. Gibbons, G. Naughton, et al. (2015). "Early childhood nutrition, active outdoor play and sources of information for families living in highly socially disadvantaged locations." Journal of Paediatrics and Child Health 51(3): 287-293.

Myers, J., S. Thorpe, et al. (2014). "Early childhood nutrition concerns, resources and services for Aboriginal families in Victoria." Australian and New Zealand Journal of Public Health 38(4): 370-376.

Trial website

TBC

Trial related presentations / publications

Public notes

The trial is the third and final phase of a complex intervention comprising a Needs Assessment (2010), and a Feasibility study (2014). 
Publications are available for previous phases. 

Filling the Gaps: Summary Needs Assessment report (2010). Department of Health, Victoria 

https://www2.health.vic.gov.au/getfile/?sc_itemid=%7B3C3B6191-8948-4C11-912F-22E9F9F7321B%7D&title=Filling%20the%20Gaps%20Early%20childhood%20nutrition%20and%20physical%20activity%20needs%20assessment%202010%3A%20Summary%20report

Contacts

Principal investigator

Name

Prof Geraldine Naughton

Address

National School of Exercise Science
Australian Catholic University
Locked Bag 4115 Fitzroy
VIC 3065

Country

Australia

Phone

+61 3 9953 3034

Fax

[email protected]

Contact person for public queries

Name

Judith Myers

Address

Murdoch Childrens Research Institute
Royal Children's Hospital
Flemington Road
Parkville
VIC 3052

Country

Australia

Phone

+61 3 9345 4383

Fax

[email protected]

Contact person for scientific queries

Name

Judith Myers

Address

Murdoch Childrens Research Institute
Royal Children's Hospital
Flemington Road
Parkville
VIC 3052

Country

Australia

Phone

+61 3 9345 4383

Fax

[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

No additional documents have been identified.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically