Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000055808
Ethics application status
Approved
Date submitted
24/11/2020
Date registered
22/01/2021
Date last updated
18/09/2023
Date data sharing statement initially provided
22/01/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Healthy Conversations @ Playgroup: Effect of a Healthy Conversations intervention for parents, targeting healthy lifestyle behaviours and obesity in young children attending community playgroups
Scientific title
Effect of a Healthy Conversations intervention for parents, targeting healthy lifestyle behaviours and obesity in young children attending community playgroups: A multi-site clustered randomised controlled trial
Secondary ID [1] 302725 0
Medical Research Future Fund (MRFF) Application ID: APP1200764
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 319849 0
Poor dietary intake 319850 0
Physical inactivity 319851 0
Excessive screen time 319852 0
Poor sleep 319853 0
Condition category
Condition code
Diet and Nutrition 317785 317785 0 0
Obesity
Public Health 317786 317786 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Healthy Conversations @ Playgroup intervention.
Playgroups will be included in the study at least 4 parent-child dyads are willing to participate in the evaluation of the intervention. Playgroups will receive fortnightly intervention sessions delivered face-to-face for 10 weeks (one school term) on-site at weekly scheduled playgroup meetings. Each session will consist of two 10- to 15-minute ‘healthy conversations’ led by a trained peer facilitator. The five ‘Healthy Conversation’ session topics will focus on mealtimes, limiting screens, supporting movement skills, bedtime routines, and celebrating achievements.

Who is a peer facilitator?
Peer Facilitators are not researchers or health professionals, but parents with young children who have training and/or experience in communications and group work facilitation. Facilitator training will involve: a preliminary online module providing background information (duration of 30 – 45 minutes); a full day face-to-face skills-based workshop; and two follow-up webinars to check-in and assist with fidelity maintenance (duration of 30 – 45 minutes each time).

What is a Healthy Conversation Intervention?
A healthy conversation takes place opportunistically between parents or carers attending regularly scheduled playgroup. With the guidance of a trained peer facilitator, parents are encouraged to share and reflect on parenting challenges related to healthy eating, screen time, physical activity, and sleep – with a view towards making small but important changes to improve their child’s lifestyle and health. The conversation typically concludes with signposting to follow-up support services or information. The core skills required for a healthy conversation include open-ended questioning, reflecting on practice, listening more than talking, and supporting individual goal setting.

Implementing Healthy Conversations at Playgroup
During each program session, a Peer Facilitator will lead two 10- to 15-minute healthy conversations related to a specific theme. The Facilitator opens the discussion with a question for the group (conversation starter) and then guides the discussion using open-ended questions and prompts. Parents are encouraged to reflect on what they currently do as parents - the actions, behaviours and strategies they use to encourage, discourage, support, or manage their child’s health behaviours. Parents are encouraged to think about “what works” for them and “what they could do differently” to achieve a better outcome. Through group discussion, parents collectively formulate ideas and strategies to deal with specific challenges. When necessary, the Facilitator provides ideas to keep the conversation moving and on track. At the end of the discussion, the Facilitator assists participants to identify an autonomy-supportive parenting strategy and develop a plan to implement the strategy at home (SMART goal setting). After each session, playgroup participants are provided links to video presentations and evidence-based information related to the topic by text message or email, based on participant preference. For ease of access, and to encourage further discussions among playgroup members, the links are also posted on the Playgroup’s Facebook page.

Process Evaluation – Assessment of Intervention Fidelity
Process evaluation will incorporate: 1) adherence to implementation via completion of a checklist at the end of each session by the facilitator; and 2) participant responsiveness via session and program feedback surveys from peer facilitators and participants.

Evaluation of outcomes
Assessors will fit children with an accelerometer on the non-dominant wrist and ask them to wear it for seven consecutive days (24 hours per day) immediately following T1-T3 assessments.
Intervention code [1] 319140 0
Prevention
Intervention code [2] 319141 0
Lifestyle
Intervention code [3] 319142 0
Behaviour
Comparator / control treatment
Wait-list control: Children allocated to the control group will be offered the 10-week program at the conclusion of their 6-month follow-up period.
Control group
Active

Outcomes
Primary outcome [1] 325806 0
(1) Dietary intake as measured by telephone-administered multi-pass 24-hour recall (valid measure of young children’s dietary intake).
Timepoint [1] 325806 0
Baseline (T1); immediately post-intervention at 10 weeks (T2); Primary timepoint); 6 months post-intervention (T3)
Primary outcome [2] 325807 0
(1) Dietary intake as measured by a 13-item food questionnaire developed by CI’s Golley and Byrne in the CRE on the Early Prevention of Obesity in Childhood (currently being validated by the research team).
Timepoint [2] 325807 0
Baseline (T1); immediately post-intervention at 10 weeks (T2); Primary timepoint); 6 months post-intervention (T3)
Primary outcome [3] 325808 0
(2) Physical activity: daily time spent in physically active movement behaviours (sum of walking, running, and moderate-to-vigorous free play) will be objectively measured using the ActiGraph GT3X+ accelerometer-based motion sensor. A validated algorithm developed by CI Trost will be used to quantify daily time spent in sedentary activities (sitting or lying down), light-intensity activities and games, walking, running, and moderate-to-vigorous intensity free play.
Timepoint [3] 325808 0
Baseline (T1); immediately post-intervention at 10 weeks (T2); Primary timepoint); 6 months post-intervention (T3)
Secondary outcome [1] 389197 0
Primary Outcome (3) Screen time as measured by 8 items from an obesity behaviour assessment tool (Movement Behaviour Questionnaire; MBQ) developed by CI’s Trost, Golley, and Byrne in the CRE on the Early Prevention of Obesity in Childhood (currently being validated by the research team).
Timepoint [1] 389197 0
Baseline (T1); immediately post-intervention at 10 weeks (T2); Primary timepoint); 6 months post-intervention (T3)
Secondary outcome [2] 389198 0
Primary Outcome (4) Sleep as measured by 4 items from the MBQ (currently being validated by the research team).
Timepoint [2] 389198 0
Baseline (T1); immediately post-intervention at 10 weeks (T2); Primary timepoint); 6 months post-intervention (T3)
Secondary outcome [3] 389199 0
Primary Outcome (4) Sleep duration and quality objectively measured using the ActiGraph GT3X+ accelerometer. Accelerometer output will be scored for sleep-wake state using the Sadeh algorithm (previously validated in children).
Timepoint [3] 389199 0
Baseline (T1); immediately post-intervention at 10 weeks (T2); Primary timepoint); 6 months post-intervention (T3)
Secondary outcome [4] 390027 0
Primary Outcome (5) Body Mass Index (BMI)-z score: BMI will be calculated from height and weight (height determined by calibrated portable stadiometer and weight determined using calibrated portable digital scales) and converted to age- and sex-specific percentiles or z-scores using the World Health Organization Growth Standards for 0-5 years.
Timepoint [4] 390027 0
Baseline (T1); immediately post-intervention at 10 weeks (T2); Primary timepoint); 6 months post-intervention (T3)
Secondary outcome [5] 390028 0
(1) Parenting measures: Parenting practices related to the four obesity risk behaviours will be assessed with the following measure:

10 items from the Feeding Practices and Structure Questionnaire (FPSQ-28)
Timepoint [5] 390028 0
Baseline (T1); immediately post-intervention at 10 weeks (T2); 6 months post-intervention (T3)
Secondary outcome [6] 390029 0
(1) Parenting measures: Parenting practices related to the four obesity risk behaviours will be assessed with the following measure:

A subset of 39 items across five scales from the Physical Activity and Screen Time Parenting Practices Scale
Timepoint [6] 390029 0
Baseline (T1); immediately post-intervention at 10 weeks (T2); 6 months post-intervention (T3)
Secondary outcome [7] 390030 0
(1) Parenting measures: Parenting practices related to the four obesity risk behaviours will be assessed with the following measure:

The Consistency scale (5 items) from the Bedtime Routines Questionnaire.
Timepoint [7] 390030 0
Baseline (T1); immediately post-intervention at 10 weeks (T2); 6 months post-intervention (T3)

Eligibility
Key inclusion criteria
Playgroups will be included in the study if at least 4 parent-child dyads are willing to participate in the evaluation of the intervention.

In each participating playgroup, parent-child dyad eligibility will be based on the following inclusion criteria parents/carers with children between the ages of 12 – 60 months.

There are no eligibility limits for parent age.
Minimum age
12 Months
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
If any of the following exclusion criteria are met, parents may participate in the intervention sessions, but will be excluded from the intervention evaluation: (1) they are unable to give informed consent; (2) they have insufficient literacy to complete the evaluation questionnaires; (3) they have children outside the target age group of 12 – 60 months; (4) they have children with chronic health conditions that may adversely influence BMI, physical activity, diet, or sleep (e.g., severe respiratory disease, congenital heart disease), will participate in the intervention, but will be excluded from the evaluation.

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)
Study staff will have no access to treatment allocation codes until time of randomisation (after study eligibility is established and baseline testing). Group allocation will occur through a secure password protected database (REDCap). Group allocation will be maintained in secure files that are inaccessible to blinded study personnel.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Group assignment for each site will be completed by an independent statistician using an allocation sequence generated by block randomisation. After baseline assessments, playgroups in each site will be randomised to the next condition (intervention or wait-list control) on the list using the database randomisation module using the Research Electronic Data Capture (REDCap) platform.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Minimal detectable differences and standard deviation estimates for samples of 20, 30, and 40 playgroup clusters per condition were examined. All calculations were performed assuming a power of 0.80, a 2-tailed alpha level of 0.05, a cluster size of 6 parent-child dyads, and an intra-cluster correlation (ICC) of 0.10 and 0.02 for the child health behaviours and BMI z-score, respectively.

Based on these calculations, a sample of 30 playgroups per condition, with 6 children per playgroup, achieves 80% power to detect the hypothesised between-group differences for each of the primary outcomes.

Research hypothesis 1: the intervention will result in net differences of 0.5 serving of vegetables (38 grams per day), 1.5 servings of discretionary foods per day, 15 minutes or 2% of time in moderate-to-vigorous physical activity, 30 minutes screen time per day, and 40 minutes of sleep per 24 h period. The null hypothesis is a net difference of zero.

Research hypothesis 2: the intervention will result in a difference of 0.30 BMI z-score units. The null hypothesis is a net difference of zero. For a 2-year-old at the 84th percentile or a BMI z-score of 1.0, a difference of 0.30 z-score units equates to a clinically meaningful reduction of 0.4 kg in excess weight.

To offset a projected attrition rate of up to 25%, we will recruit an additional 2 children within each playgroup, providing an overall sample of 60 community playgroups and 480 parent-child dyads.

Between-group differences in the primary and secondary outcomes will be tested using a general linear mixed model, which accounts for the clustering of children within playgroups. Within each model, condition, time, the condition by time interaction will be included as fixed effects, with playgroup nested within condition and the playgroup by time interaction nested within condition included as random effects.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2021
Actual
22/04/2021
Date of last participant enrolment
Anticipated
31/07/2022
Actual
19/07/2022
Date of last data collection
Anticipated
31/01/2023
Actual
13/06/2023
Sample size
Target
60
Accrual to date
Final
51
Recruitment in Australia
Recruitment state(s)
QLD,SA,WA

Funding & Sponsors
Funding source category [1] 307151 0
Government body
Name [1] 307151 0
Australian Government, Medical Research Future Fund
Country [1] 307151 0
Australia
Primary sponsor type
Individual
Name
Professor Stewart Trost
Address
Queensland University of Technology. Level 6, 62 Graham Street, South Brisbane QLD 4101
Country
Australia
Secondary sponsor category [1] 307739 0
None
Name [1] 307739 0
Address [1] 307739 0
Country [1] 307739 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307264 0
Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 307264 0
Ethics committee country [1] 307264 0
Australia
Date submitted for ethics approval [1] 307264 0
08/07/2020
Approval date [1] 307264 0
22/07/2020
Ethics approval number [1] 307264 0
LNR/2020/QCHQ/66486

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

Contacts
Principal investigator
Name 106618 0
Prof Stewart Trost
Address 106618 0
Queensland University of Technology. Level 6, 62 Graham Street, South Brisbane QLD 4101.
Country 106618 0
Australia
Phone 106618 0
+61 7 3069 7301
Fax 106618 0
Email 106618 0
[email protected]
Contact person for public queries
Name 106619 0
Stewart Trost
Address 106619 0
Queensland University of Technology. Level 6, 62 Graham Street, South Brisbane QLD 4101.
Country 106619 0
Australia
Phone 106619 0
+61 7 3069 7301
Fax 106619 0
Email 106619 0
[email protected]
Contact person for scientific queries
Name 106620 0
Stewart Trost
Address 106620 0
Queensland University of Technology. Level 6, 62 Graham Street, South Brisbane QLD 4101.
Country 106620 0
Australia
Phone 106620 0
+61 7 3069 7301
Fax 106620 0
Email 106620 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?
Researchers will be able to contact the PI for access to data. Data will be maintained in a csv format to enable open re-use of the data. Data available will be all of the individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Immediately following main results publication; no end date determined.
Available to whom?
Case-by-case basis at the discretion of Primary Investigator
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approvals by Principal Investigator. Approvals may be sought by emailing the Principle Investigator directly at [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.