Trial Review

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
ACTRN12624001492549
Ethics application status
Approved
Date submitted
2/12/2024
Date registered
20/12/2024
Date last updated
20/12/2024
Date data sharing statement initially provided
20/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Health4Life Parents & Teens Optimisation Trial
Scientific title
Health4Life Parents & Teens: Optimisation of a parent-based intervention to reduce modifiable cancer risk factors among socio-economically disadvantaged adolescents
Secondary ID [1] 313407 0
MRF2021535
Universal Trial Number (UTN)
Trial acronym
Linked study record
This is a follow-up study of ACTRN12619000431123 (The Health4Life Study). The current trial aims to develop a parent intervention to accompany the school-based Health4Life intervention evaluated in ACTRN12619000431123.

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 335624 0
Sedentary behaviours (screen time) 336022 0
Alcohol use 336023 0
Smoking 336026 0
Poor diet 336027 0
Poor sleep duration/quality 336028 0
E-cigarette use/vaping 336029 0
Condition category
Condition code
Public Health 332182 332182 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Guided by the Multiphase Optimisation Strategy (MOST) framework, this study is an optimisation trial of the "Health4Life Parents & Teens" intervention. Delivered to parents, the intervention aims to support parents experiencing socio-economic disadvantage to improve modifiable lifestyle risk factors (e.g., physical inactivity, poor diet, smoking/vaping, alcohol use, screen time, and poor sleep) among their adolescent children.

The intervention consists of five components delivered via a custom-built online platform (https//parentsandteens.org.au). Parents will be randomised to one of 16 conditions, receiving varying combinations of the following components:

1. ONLINE MODULES (Core component)
All parents will receive access to six online modules available via the Health4Life Parents and Teens study website, one module per risk factor: screen time and social media, smoking and vaping, alcohol, sleep, food and nutrition, and physical activity. The modules are designed to empower parents to support their adolescent child to adopt healthy behaviours by enhancing parental self-efficacy and improving health literacy about lifestyle risk factors. Each module will comprise a 10-minute video podcast, an interactive summary of parenting strategies, and goal setting exercise. Content will focus on promoting role-modelling, rule-setting, parental monitoring, and high quality parent-child communication. The modules will take approximately 20 minutes to complete, and are designed to be completed once per week, over 6 weeks.

2) WEB-BASED TAILORED FEEDBACK
Parents randomised to this component will receive tailored feedback about their parenting practices in relation to adolescent risk behaviours via the study website. Each week, parents will be prompted to answer one parenting-related question (aligning with the online module they are about to begin e.g. “screen time & social media”). The self-report questions were derived from our primary outcome measure (i.e. health habits sub-scale from the PRADAS questionnaire; Yap et al 2017). Responses are made on a four-point scale (never, rarely, sometimes, often). Based on their responses, parents will receive colour-coded, strengths-based feedback and motivational advice about their encouragement of their teen’s health habits. The feedback aims to help parents to identify behaviours to increase, decrease or maintain. Using this system, ‘green’ notifications will be provided to parents when they answer ‘often’ (‘Going Strong’), ‘orange’ notifications will be shown to parents when they respond ‘sometimes’ (‘Needs some work’) and ‘red’ notifications are shown when parents say they ‘never’ or ‘rarely’ do the parenting practice (‘Action encouraged’). Parents will then be prompted to complete the online module/podcast to learn more detailed parenting strategies. Parents will received feedback on one risk behaviour per week, over a total of 6 weeks.

3) STRESS MANAGEMENT TRAINING
Parents randomised to this condition will have access to an additional online stress management module. Consistent with the core intervention, content will be delivered via a 10-minute video podcast, delivered via a registered psychologist. Parents will then complete brief interactive activities relating to parenting strategies to manage household stress and a goal setting activity. The key content will cover the physical, mental and social impacts of consistent stress, work-life balance planning, creating family routines, identifying and responding to stress triggers, managing financial stress, self-care strategies to reduce stress and skill building as a protective factor. The module will also contain links to resources to provide opportunities to practice stress alleviation and challenge negative beliefs. This component will take approximately 20-minutes to complete in total. It is designed as a one-off module, available to parents after the six "core" modules.

4) TEXT MESSAGES
Text messages will be sent to parents to provide social support, supportive accountability and encourage intervention engagement. Based on our previous studies, a bank of text messages were developed in consultation with parents. Text messages will be semi-personalised (e.g. name) and delivered via our study website. Text messages will be triggered by interaction events with the website (e.g. starting a module, completing a module). Participants will receive 2-3 text messages per week, over the 6-week intervention period.

5) HEALTH COACHING
Parents randomised to this component will receive weekly coaching calls with a trained health coach (minimum Bachelor degree in health promotion, psychology or related health field). Parents will choose to receive the coaching calls via phone or video call (e.g. Zoom) and will pick a suitable day and time for the calls to take place. The health coach will follow a semi-structured manual, with 10% of calls to be audio-taped to monitor fidelity. The manual will be guided by principles of supportive accountability from Mohr et al.’s (2011) Supportive Accountability Model, It will prompt the coach to check-in on participant progress with the intervention, troubleshoot any technical issues with the study website and/or barriers to intervention engagement, and check-in on progress against goals. The phone calls will take approximately 15-20 minutes each, and will be delivered once per week over the 6-week intervention period.

Participants will be allocated to 1 of the following 16 experimental conditions:
1. Online Modules + Tailored Feedback + Stress Management + Text Messages + Health Coaching
2. Online Modules + Tailored Feedback + Stress Management + Text Messages
3. Online Modules + Tailored Feedback + Stress Management + Health Coaching
4. Online Modules + Tailored Feedback + Stress Management
5. Online Modules + Tailored Feedback + Text Messages + Health Coaching
6. Online Modules + Tailored Feedback + Text Messages
7. Online Modules + Tailored Feedback + Health Coaching
8. Online Modules + Tailored Feedback
9. Online Modules + Stress Management + Text Messages + Health Coaching
10. Online Modules + Stress Management + Text Messages
11. Online Modules + Stress Management + Health Coaching
12. Online Modules + Stress Management
13. Online Modules + Text Messages + Health Coaching
14. Online Modules + Text Messages
15. Online Modules + Health Coaching
16. Online Modules

PROCESS OUTCOMES
Following completion of each module, parents will be asked to provide a brief rating (out of 5 stars) via the study website. In addition, a brief self-report online questionnaire will be delivered to parents after the intervention period. To assess the acceptability of the intervention, parents will be asked to rate the acceptability of each component and the suitability of the length of each component. Parents will also be asked to report the effort it took to complete each component of the intervention that they were assigned to (ranging from ‘no effort at all’ to ‘huge effort’). This item was adapted from an existing Theoretical Framework of Acceptability questionnaire (Sekhon et al, 2022). Objective data will be collected via the study website to assess parent’s engagement with each intervention component, e.g. number of modules accessed, number completed, and the number of goals set. Health coaches will record the number of coaching sessions attended, the ode of communication (e.g., phone, Zoom) and duration of each contact.
Intervention code [1] 329863 0
Prevention
Intervention code [2] 329864 0
Lifestyle
Intervention code [3] 330009 0
Behaviour
Comparator / control treatment
Because of the MOST study design, there is no comparator/control treatment as such. Instead, the main effects of, and interactions between, intervention components will be determined.
Control group
Active

Outcomes
Primary outcome [1] 339769 0
Parental encouragement of adolescent health habits
Timepoint [1] 339769 0
Baseline and 3-month follow-up
Secondary outcome [1] 441224 0
Parental Self-Efficacy
Timepoint [1] 441224 0
Baseline and 3-month follow-up.
Secondary outcome [2] 442046 0
Health Literacy
Timepoint [2] 442046 0
Baseline and 3-month follow-up
Secondary outcome [3] 442047 0
Perceived parental stress
Timepoint [3] 442047 0
Baseline, 3-month follow-up
Secondary outcome [4] 442049 0
Parent-Adolescent Communication
Timepoint [4] 442049 0
Baseline and 3-month follow-up
Secondary outcome [5] 442050 0
Supportive Accountability
Timepoint [5] 442050 0
Baseline and 3-month follow-up
Secondary outcome [6] 442782 0
Parent's recreational screen time
Timepoint [6] 442782 0
Baseline and 3-month follow-up
Secondary outcome [7] 442784 0
Parent's fruit and vegetable intake
Timepoint [7] 442784 0
Baseline and 3-month follow-up
Secondary outcome [8] 442788 0
Parent's sugar-sweetened beverages intake
Timepoint [8] 442788 0
Baseline and 3-month follow-up
Secondary outcome [9] 442793 0
Parent's moderate to vigorous physical activity
Timepoint [9] 442793 0
Baseline and 3-month foll0w-up
Secondary outcome [10] 442794 0
Parent's alcohol use
Timepoint [10] 442794 0
Baseline and 3-month follow-up
Secondary outcome [11] 442795 0
Parent's cigarette smoking
Timepoint [11] 442795 0
Baseline and 3-month follow-up
Secondary outcome [12] 442796 0
Parent's e-cigarette use (vaping)
Timepoint [12] 442796 0
Baseline and 3-month follow-up
Secondary outcome [13] 442797 0
Parent's alcohol use (frequency)
Timepoint [13] 442797 0
Baseline and 3-month follow-up
Secondary outcome [14] 442798 0
Parent's alcohol use (quantity)
Timepoint [14] 442798 0
Baseline and 3-month follow-up
Secondary outcome [15] 442801 0
Discretionary food intake
Timepoint [15] 442801 0
Baseline and 3-month follow-up

Eligibility
Key inclusion criteria
* Mother, father, guardian or carer of 11-15year-old

* Living in disadvantaged areas of NSW, as determined by Australian Bureau of Statistics’ Index of Relative Socio-economic Disadvantage (IRSD) scores. Specifically, parents must be living within suburbs classified in the bottom two quintiles (1 or 2).

*Willingness to provide informed consent

* Access to the internet to participate in the online program (either at home or a public location like a library).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
*Unable to provide contact information or informed consent

*Unable to access the internet to participate in the program (either in the private residence of the participant, or a public library/other suitable venue with internet access)

*Participant identified as a bot or disingenuous (i.e. providing fraudulent responses to receive financial compensation)

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)
Concealed, central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A biostatistician with no role in participant recruitment will produce the randomisation scheme using the Blockrand function in R. Randomisation will proceed using a blocked random allocation method with randomly selected block sizes to ensure an equal number of participants in each group, while preventing selection bias that can occur when using fixed block sizes.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To achieve 80% power to detect an effect size of 0.27 in our primary outcome (i.e. parental encouragement of adolescent health habits), we estimated that we need 261 participants at the 3-month follow-up. This is consistent with a previous randomised controlled trial of a comparable web-based intervention among Australian parents which found a small effect (d=0.27) when examining pre-post intervention change on the PRADAS questionnaire (Yap et al., 2018). To obtain an equal number of participants in each experimental condition, we will need 272 participants (i.e. 17 parents per condition). To account for ~30% attrition at 3-months, we will aim to recruit a total of 389 participants.

Linear mixed effect (multilevel) models will test whether each intervention component had a minimum effect of =d=0.27 on the primary outcome at 3-months accounting for repeated measures nested within participants. Data will be analysed on an intent-to-treat basis and each intervention component will be coded using mean effect coding to enable interpretation of the regression coefficients (main effects) as the mean difference from the grand mean of all components. Random effects will be entered for each participant whereas time and component levels will be entered as fixed effects. An interaction between time and component will be included to investigate significant change in the outcome over time. Next, models will test 2- and 3-way interactions between components to identify synergistic or antagonistic effects on the primary outcome. Results will be used to determine which components should be eliminated, and of those that remain, which set of components produces the best improvement on the primary outcome. To address our secondary aim of assembling an optimised intervention producing the greatest improvement in our primary outcome attainable, with the least possible burden to parents, we will estimate the time taken to complete each component. We will use a combination of website engagement metrics and parent-reported burden associated with each component.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/01/2025
Actual
Date of last participant enrolment
Anticipated
1/07/2025
Actual
Date of last data collection
Anticipated
31/10/2025
Actual
Sample size
Target
389
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 317722 0
Government body
Name [1] 317722 0
Australian Government Department of Health and Aged Care, Medical Research Future Fund (MRFF)
Country [1] 317722 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 320038 0
University
Name [1] 320038 0
The University of Newcastle
Address [1] 320038 0
Country [1] 320038 0
Australia
Other collaborator category [1] 283272 0
Government body
Name [1] 283272 0
Sydney Local Health District (SLHD)
Address [1] 283272 0
Country [1] 283272 0
Australia
Other collaborator category [2] 283273 0
Government body
Name [2] 283273 0
Nepean Blue Mountains Local Health District (NBMLHD)
Address [2] 283273 0
Country [2] 283273 0
Australia
Other collaborator category [3] 283302 0
University
Name [3] 283302 0
Florida State University
Address [3] 283302 0
Country [3] 283302 0
United States of America
Other collaborator category [4] 283303 0
University
Name [4] 283303 0
Monash University
Address [4] 283303 0
Country [4] 283303 0
Australia
Other collaborator category [5] 283304 0
University
Name [5] 283304 0
University of the Sunshine Coast
Address [5] 283304 0
Country [5] 283304 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316412 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 316412 0
Ethics committee country [1] 316412 0
Australia
Date submitted for ethics approval [1] 316412 0
30/09/2024
Approval date [1] 316412 0
16/12/2024
Ethics approval number [1] 316412 0
2024/HE001483

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

Contacts
Principal investigator
Name 137806 0
Dr Katrina Champion
Address 137806 0
The Matilda Centre for Research in Mental Health and Substance Use The University of Sydney Darlington, NSW 2006
Country 137806 0
Australia
Phone 137806 0
+61 2 8627 9048
Fax 137806 0
Email 137806 0
katrina.champion@sydney.edu.au
Contact person for public queries
Name 137807 0
Katrina Champion
Address 137807 0
The Matilda Centre for Research in Mental Health and Substance Use The University of Sydney Darlington, NSW 2006
Country 137807 0
Australia
Phone 137807 0
+61 2 8627 9048
Fax 137807 0
Email 137807 0
katrina.champion@sydney.edu.au
Contact person for scientific queries
Name 137808 0
Katrina Champion
Address 137808 0
The Matilda Centre for Research in Mental Health and Substance Use The University of Sydney Darlington, NSW 2006
Country 137808 0
Australia
Phone 137808 0
+61 2 8627 9048
Fax 137808 0
Email 137808 0
katrina.champion@sydney.edu.au

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?

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.