Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000325606
Ethics application status
Approved
Date submitted
4/02/2023
Date registered
27/03/2023
Date last updated
15/05/2024
Date data sharing statement initially provided
27/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of the SMILESup mobile health intervention on oral health literacy and early childhood dental caries.
Scientific title
Supporting parents/carers of young children with tooth decay to use a mobile health (text message) intervention (SMILESup) targeting oral health literacy, self-efficacy and behaviours, and opportunities to scale: a pilot randomised control trial of feasibility, preliminary efficacy.
Secondary ID [1] 308495 0
none
Universal Trial Number (UTN)
Trial acronym
SMILESup
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dental Caries 328319 0
Condition category
Condition code
Oral and Gastrointestinal 325360 325360 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
SMILESup: is a 3-month text messaging intervention consisting oral health lifestyle text messages delivered via mobile phone to parents of children who are waiting for a dental general anaesthesia appointment.

The SMILESup text messages are semi-personalised text messages that have been co-designed by consumers (parents and carers) and health professionals. These text messages will be sent out 4 days/ week, for 3 months (48 text messages in total) on the Textcare™ platform. The Textcare™ platform is a purpose-built cloud-based delivery system that can semi-personalise the content and frequency of delivery. It includes safety, privacy, and security systems with analytic data collection. Semi-personalised messages may also mean that they will include the participant child’s preferred name and specifications, such as the timing of when they would like to receive the messages at home. The text-messages will primarily be one-way and prompt participants to change their behaviours by providing practical tips and strategies. The Textcare platform will be monitored by a clinician researcher.

Content for text messages will be aligned with the WHO’s Ending childhood dental caries: Implementation manual and the literature and focus on key areas of: 1) oral hygiene, including age-appropriate use of fluorides, 2) diet, including increased consumption of water and 3) night-time routine, specific to the timing of diet and tooth brushing habits.

Text messages will be co-designed by researchers, clinicians and consumers, with inital content adapted and curated from the World Health Organisation (WHOs) BeHealthyBeMobile oral health program. These messages will also draw on oral health promotional content from the NSW Health website. A 4-hour co-design workshop will occur 2 months before the study commencement.
Intervention code [1] 324937 0
Prevention
Intervention code [2] 324938 0
Early detection / Screening
Intervention code [3] 324948 0
Behaviour
Comparator / control treatment
The control group will receive an introductory text message that links them to the NSW Health webpage for oral health promotion information. They will continue to receive one text message a month asking about their brushing habits. For this study usual care is defined as accessing currently available health information within health services and general oral health promotional content from the NSW Health website. After the three-month RCT trial, they will have the option to be provided with the SMILESup text message program.
Control group
Active

Outcomes
Primary outcome [1] 333227 0
Self-reported tooth brushing habits for the child by the parent using parental self-reported questionnaire
Specifically, “How often do you brush your child’s teeth with toothpaste?”
Timepoint [1] 333227 0
At baseline, 1 month , 2 months , and at 3 months (primary time point) after randomisation
Secondary outcome [1] 416235 0
Self-reported oral hygiene behaviour of the child, by the parents related to the type of toothpaste used.
Specifically, “What type of toothpaste do you put on our child’s toothbrush?”
Timepoint [1] 416235 0
At baseline and at 3 months after randomisation.
Secondary outcome [2] 419271 0
Self-reported dietary behaviour of the child, by the parent related to the number of sweet drinks a child has per week.
Specifically, “How often does your child drink sugar sweetened drinks?”
Timepoint [2] 419271 0
At baseline and at 3 months after randomisation.
Secondary outcome [3] 419272 0
Self-reported dietary behaviour of the child, by the parent related to the number of sweet foods a child has per week.
Specifically, “How often does your child eat sweet foods?”
Timepoint [3] 419272 0
At baseline and at 3 months after randomisation.
Secondary outcome [4] 419273 0
Self-reported dietary behaviour of the child, by the parent related to the night-time milk consumption?
Specifically, “How often does your child go to bed with a cup or a bottle of milk?"
Timepoint [4] 419273 0
At baseline and at 3 months after randomisation.
Secondary outcome [5] 419274 0
Self-reported dietary behaviour of the child, by the parent related to the frequency of water consumption?
Specifically, “How often does your child drink water?”
Timepoint [5] 419274 0
At baseline and at 3 months after randomisation.
Secondary outcome [6] 419275 0
Self-reported oral health self-efficacy measured using parental self-reported questionnaire with standardised questions from the Capability, Opportunity, and Motivation (COM) of the Behaviour Change Wheel (BCW) theoretical framework; this is a composite secondary outcome.
Timepoint [6] 419275 0
At baseline and at 3 months after randomisation.
Secondary outcome [7] 419276 0
Fidelity of the intervention (i.e., was the intervention conducted as planned/intended) using the Textcare and REDCap database that has been developed to document the implementation of the study.
Timepoint [7] 419276 0
Regular intervals (fortnightly) from start of the study until 3 months after study commencement.
Secondary outcome [8] 419277 0
Reach of the intervention using the Textcare and REDCap database that has been developed to document the implementation of the study maintained by research team.
Timepoint [8] 419277 0
After the completion of the study.
Secondary outcome [9] 419925 0
Barriers, enablers, and the opportunities to scale the program from the consumer perspective- composite secondary outcomes, with the method of collection through focus groups or semi-structured interviews
Timepoint [9] 419925 0
After the completion of the trial
Secondary outcome [10] 419926 0
Barriers, enablers, and the opportunities to scale the program from the health professional perspective- composite secondary outcomes, with the method of collection through focus groups or semi-structured interviews
Timepoint [10] 419926 0
After completion of the trial

Eligibility
Key inclusion criteria
Inclusion criteria are parents/carers of children; children must have all of the following: 1)diagnosis of dental caries (tooth decay), 2) age 0 to 6 years old, 3) waiting (or have attended) a hospital admission for dental caries (tooth decay) within the public health system in NSW.

Parents/carers of these children must also own an operational mobile phone, capable of sending and receiving SMS text messages; and provide written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Parents/carers will be excluded if they do not have a child (0 to 6 years) waiting or who has had hospital admission for dental caries (tooth decay) within the public health system in NSW. Furthermore, parents will be excluded if they : 1) are already participating in a text message-based study on lifestyle risk factors for health, 2)have insufficient English skills to provide informed consent or read and understand text messages; and 3)are unable to comply with study requirements.

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)
Allocation concealment will be centrally randomised by a computer-generated sequence and managed by the Research Electronic Data Capture platform (REDCap). Researchers will be blinded to the allocation. Participants will be notified of their treatment allocation via text message from the Textcare platform. Participants will know which group they have been allocated by receiving this message.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation). Participants will be randomly assigned to either the control or the intervention group with a 1:1 allocation ratio, stratified by recruitment site.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The analysis of the primary and secondary outcomes will be according to the intention-to-treat principle. The primary outcome will be a binary (yes/no) response to the question “How often do you brush your child’s teeth with toothpaste?” A yes response will be considered for patients answering, “Twice a day” or “More than twice a day” and a no response to those answering, “once a day”, “few times a week”, or “don’t know /unsure”. The primary analysis will be conducted using logistic regression. The odds ratio will be reported with a 95% confidence interval, a statistical significance level of 0.05 will be used. Secondary outcomes will be analysed using logistic regression for binary outcomes and linear regression analysis for continuous variables. Sub-group analyses may also be conducted comparing demographic variables, parental level of education (high vs. low) or families with single vs. multiple children.

A sample size of approximately 150 will achieve a 80% power, to observe a meaningful difference of 25% increase of participants who brush twice a day in the intervention compared to the control group at three months (52% to 77%), using a 5% level of significance and accounting for a drop out of 25%. A cross-sectional study of a similar Australian population group reported 52% of children between 3-8 years old brushing twice a day1.

All qualitative data will be analysed using NVivo version 12.02 and qualitative methodologies, following Braun & Clarke’s thematic analysis3. Any quantitative metrics to assess fidelity will be analysed by R or SPSS v224.

References
1. Tadakamadla SK, Rathore V, Mitchell AE, Kaul A, Morawska A. Child- and family-level factors associated with toothbrushing frequency in a sample of Australian children. International journal of paediatric dentistry. 2022;32(5):639-648.
2. NVivo qualitative data analysis software; QSR International Pty Ltd. Version 12, 2018.
3. Braun V, Clarke V. Thematic analysis : a practical guide. London: SAGE Publications Ltd; 2022.
4. IBM Corp. Released 2013. IBM SPSS Statistics for Windows, Version 22.0. Armonk, NY: IBM Corp.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/06/2023
Actual
24/08/2023
Date of last participant enrolment
Anticipated
24/05/2024
Actual
Date of last data collection
Anticipated
23/08/2024
Actual
Sample size
Target
150
Accrual to date
137
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 24209 0
Westmead Hospital - Westmead
Recruitment hospital [2] 24210 0
Sydney Dental Hospital - Surry Hills
Recruitment postcode(s) [1] 39742 0
2145 - Westmead
Recruitment postcode(s) [2] 39743 0
2010 - Surry Hills

Funding & Sponsors
Funding source category [1] 312752 0
University
Name [1] 312752 0
The University of Sydney
Country [1] 312752 0
Australia
Primary sponsor type
Government body
Name
Western Sydney Local Health District
Address
Research and Education Network
Darcy Rd, Westmead Hospital
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 314380 0
None
Name [1] 314380 0
Address [1] 314380 0
Country [1] 314380 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312032 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 312032 0
Ethics committee country [1] 312032 0
Australia
Date submitted for ethics approval [1] 312032 0
20/09/2022
Approval date [1] 312032 0
12/12/2022
Ethics approval number [1] 312032 0
2022/ETH01920

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

Contacts
Principal investigator
Name 123246 0
Prof Clara K Chow
Address 123246 0
The University of Sydney, Faculty of Medicine and Health, Westmead Applied Research Centre
Level 6, Block K, Entrance 10, Westmead Hospital, Hawkesbury Road, Westmead, NSW, 2145
NSW 2145
Country 123246 0
Australia
Phone 123246 0
+61 414488325
Fax 123246 0
Email 123246 0
clara.chow@sydney.edu.au
Contact person for public queries
Name 123247 0
Rebecca Chen
Address 123247 0
The University of Sydney, Faculty of Medicine and Health, Westmead Applied Research Centre
Level 6, Block K, Entrance 10, Westmead Hospital, Hawkesbury Road, Westmead, NSW, 2145
Country 123247 0
Australia
Phone 123247 0
+61 2 8890 3125
Fax 123247 0
Email 123247 0
rebecca.chen@sydney.edu.au
Contact person for scientific queries
Name 123248 0
Rebecca Chen
Address 123248 0
The University of Sydney, Faculty of Medicine and Health, Westmead Applied Research Centre
Level 6, Block K, Entrance 10, Westmead Hospital, Hawkesbury Road, Westmead, NSW, 2145
Country 123248 0
Australia
Phone 123248 0
+61 2 8890 3125
Fax 123248 0
Email 123248 0
rebecca.chen@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.