Trial Review

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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] 287292 0
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 295932 0
Condition category
Condition code
Public Health 296192 296192 0 0
Health promotion/education
Public Health 296193 296193 0 0
Health service research
Diet and Nutrition 296312 296312 0 0
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] 292614 0
Prevention
Intervention code [2] 292615 0
Lifestyle
Intervention code [3] 292616 0
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] 295862 0
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] 295862 0
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] 316749 0
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] 316749 0
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] 316750 0
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] 316750 0
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] 316751 0
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] 316751 0
Continuous data collection during the intervention, i.e. from baseline (T = 1) to 10 weeks (T = 2).
Secondary outcome [4] 317070 0
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] 317070 0
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] 291861 0
University
Name [1] 291861 0
Australian Catholic University
Country [1] 291861 0
Australia
Funding source category [2] 291862 0
Charities/Societies/Foundations
Name [2] 291862 0
Windermere Foundation
Country [2] 291862 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
Locked Bag 4115, Fitzroy, VIC 3065
Country
Australia
Secondary sponsor category [1] 290593 0
None
Name [1] 290593 0
Address [1] 290593 0
Country [1] 290593 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293371 0
Australian Catholic University
Ethics committee address [1] 293371 0
Ethics committee country [1] 293371 0
Australia
Date submitted for ethics approval [1] 293371 0
Approval date [1] 293371 0
20/12/2013
Ethics approval number [1] 293371 0
2013 177V
Ethics committee name [2] 293372 0
Department of Education and Training
Ethics committee address [2] 293372 0
Ethics committee country [2] 293372 0
Australia
Date submitted for ethics approval [2] 293372 0
Approval date [2] 293372 0
31/03/2014
Ethics approval number [2] 293372 0
2014_002283

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

Contacts
Principal investigator
Name 59598 0
Prof Geraldine Naughton
Address 59598 0
National School of Exercise Science
Australian Catholic University
Locked Bag 4115 Fitzroy
VIC 3065
Country 59598 0
Australia
Phone 59598 0
+61 3 9953 3034
Fax 59598 0
Email 59598 0
[email protected]
Contact person for public queries
Name 59599 0
Judith Myers
Address 59599 0
Murdoch Childrens Research Institute
Royal Children's Hospital
Flemington Road
Parkville
VIC 3052
Country 59599 0
Australia
Phone 59599 0
+61 3 9345 4383
Fax 59599 0
Email 59599 0
[email protected]
Contact person for scientific queries
Name 59600 0
Judith Myers
Address 59600 0
Murdoch Childrens Research Institute
Royal Children's Hospital
Flemington Road
Parkville
VIC 3052
Country 59600 0
Australia
Phone 59600 0
+61 3 9345 4383
Fax 59600 0
Email 59600 0
[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

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