Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000566831
Ethics application status
Approved
Date submitted
18/03/2021
Date registered
14/05/2021
Date last updated
14/05/2021
Date data sharing statement initially provided
14/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of an online program for parents on oral hygiene practices in children
Scientific title
Effect of the Healthy Habits for Life online parenting intervention on oral hygiene practices and dental caries in young children
Secondary ID [1] 301638 0
NHMRCApp#1161659
Universal Trial Number (UTN)
U1111-1254-2953
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dental caries 318051 0
Poor oral health 321552 0
Condition category
Condition code
Oral and Gastrointestinal 316082 316082 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Public Health 316083 316083 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Healthy Habits for Life- Oral health intervention is designed to improve parenting practices and confidence related to children’s oral health-related behaviour (tooth brushing, snacking practices and dental visits), thereby preventing dental caries in children. It is based on a social learning model to promote self-regulation in children, which forms the theoretical basis of Triple P (Positive Parenting Program). This program is easy to use and engaging, and includes interactive features like video/audio clips, goal-setting activities, reminders, and progress trackers. It is compatible for use on a smartphone, tablet or computer and has four specific modules: the importance of starting early, tooth brushing, snacking and drinks and visiting the dentist preceded by a module on general parenting principles. Information about parents’ access, time online, and module completion will be collected remotely. Participants in the intervention group will be encouraged to complete all the modules within two weeks of allocation. The online modules take 3-4 hours to complete but parents are encouraged to complete them at their own pace. The module "Importance of starting early" presents information related to why it is important to encourage healthy habits early. Content on how to set up the routines, dealing with the resistance, building independence and coping is covered for each oral health behaviour in modules 2-4.
Intervention code [1] 317943 0
Behaviour
Intervention code [2] 317944 0
Prevention
Comparator / control treatment
The control group will receive web links to Queensland Health and Australian Dental Association guidance for maintaining oral hygiene in children The control group will have access to the intervention after completing their 18-month follow-up assessment.
Control group
Active

Outcomes
Primary outcome [1] 324277 0
Daily tooth brushing frequency
Two sources will be used to collect this data: powered toothbrushes and self-report.
-Data on tooth brushing frequency and time spent at each session will be remotely collected through the oral-B app installed on parents' mobile device, which stores the toothbrushing data when linked to the powered toothbrush handle through bluetooth.
- Self-reported toothbrushing information will be collected every 3 months for a period of 12 months using three-months toothbrushing charts. Parents/children will tick after brushing in the morning and evening every day.
Timepoint [1] 324277 0
Baseline, and 6 weeks (primary endpoint), 6 months, and 12 months post-intervention completion
Secondary outcome [1] 384237 0
Parenting strategies used to promote toothbrushing in children using "Parent and Child Toothbrushing Assessment" (PACTA) questionnaire. PACTA has been found to be a valid and reliable measure.

Timepoint [1] 384237 0
Baseline, and 6 weeks, 6 months and 12 months post-intervention completion
Secondary outcome [2] 393021 0
Dental Caries, quantified using dmft index
Timepoint [2] 393021 0
Baseline, and 12 months and 18 months post-intervention completion
Secondary outcome [3] 394080 0
Dental visiting habits assessed using a study-specific questionnaire
Timepoint [3] 394080 0
Baseline, and 6-weeks, 6 months and 12 months post-intervention completion
Secondary outcome [4] 394081 0
Frequency of consumption of sugar-rich foods and drinks among children assessed using a study-specific questionnaire
Timepoint [4] 394081 0
Baseline, and 6 weeks, 6 months and 12 months post-intervention completion
Secondary outcome [5] 395455 0
Toothbrushing behaviour in children assessed using "Parent and Child Toothbrushing Assessment" (PACTA) questionnaire,
Timepoint [5] 395455 0
Baseline, and 6 weeks, 6 months and 12 months post-intervention completion
Secondary outcome [6] 395456 0
Parental self-efficacy in managing difficult child toothbrushing behaviours assessed using "Parent and Child Toothbrushing Assessment" (PACTA) questionnaire,
Timepoint [6] 395456 0
Baseline, and 6 weeks, 6 months and 12 months post-intervention completion
Secondary outcome [7] 395458 0
Parental attitudes towards toothbrushing in children assessed using "Parent and Child Toothbrushing Assessment" (PACTA) question
Timepoint [7] 395458 0
Baseline, and 6 weeks, 6 months and 12 months post-intervention completion
Secondary outcome [8] 395459 0
Parents' knowledge about toothbrushing in children assessed using "Parent and Child Toothbrushing Assessment" (PACTA) question
Timepoint [8] 395459 0
Baseline, and 6 weeks, 6 months and 12 months post-intervention completion
Secondary outcome [9] 395463 0
Parents’ confidence in dealing with children’s demands for sugar-rich foods using The Comprehensive Snack Parenting Questionnaire
Timepoint [9] 395463 0
Baseline, and 6 weeks, 6 months and 12 months post-intervention completion

Eligibility
Key inclusion criteria
(1) Having a child aged 2-6 years,
(2) Able to read and understand English,
(3) Provide written informed consent
(4) Having access to a device (e.g. smartphone, tablet, computer) with internet access.
Minimum age
2 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Family members of a parent or child already participating in the study will be excluded

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/05/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
162
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 306073 0
Government body
Name [1] 306073 0
National Health and Medical Research Council
Country [1] 306073 0
Australia
Funding source category [2] 308143 0
Commercial sector/Industry
Name [2] 308143 0
Oral B
Country [2] 308143 0
Australia
Primary sponsor type
Individual
Name
Dr Santosh Kumar Tadakamadla
Address
Room: 7.63, Level 7
School of Medicine and Dentistry
Griffith Health Building (G40)
Cnr Olsen Ave and
Parklands Dr
Southport QLD 4215
Country
Australia
Secondary sponsor category [1] 308908 0
Individual
Name [1] 308908 0
A/Prof Alina Morawska
Address [1] 308908 0
13 Upland Rd,
Parenting and Family Support Centre,
School of Psychology,
The University of Queensland,
Brisbane QLD 4072
Country [1] 308908 0
Australia
Secondary sponsor category [2] 309173 0
Individual
Name [2] 309173 0
Dr Amy Mitchell
Address [2] 309173 0
Health Sciences (N48) Room 2.20,
School of Nursing and Midwifery,
Griffith University,
Nathan,
QLD 4111.
Country [2] 309173 0
Australia
Secondary sponsor category [3] 309174 0
Individual
Name [3] 309174 0
Dr Vatsna Rathore
Address [3] 309174 0
Room: 5.51, Level 5
School of Medicine and Dentistry
Griffith Health Building (G40)
Cnr Olsen Ave and
Parklands Dr
Southport QLD 4215
Country [3] 309174 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306295 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 306295 0
Ethics committee country [1] 306295 0
Australia
Date submitted for ethics approval [1] 306295 0
Approval date [1] 306295 0
25/11/2020
Ethics approval number [1] 306295 0
2020/700
Ethics committee name [2] 308129 0
University of Queensland's Human Research Ethics Committee
Ethics committee address [2] 308129 0
Ethics committee country [2] 308129 0
Australia
Date submitted for ethics approval [2] 308129 0
Approval date [2] 308129 0
02/12/2020
Ethics approval number [2] 308129 0

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

Contacts
Principal investigator
Name 103398 0
Dr Santosh Kumar Tadakamadla
Address 103398 0
Room: 7.63, Level 7
School of Medicine and Dentistry
Griffith Health Building (G40)
Cnr Olsen Ave and
Parklands Dr
Southport QLD 4215
Country 103398 0
Australia
Phone 103398 0
+61 756780153
Fax 103398 0
Email 103398 0
[email protected]
Contact person for public queries
Name 103399 0
Santosh Kumar Tadakamadla
Address 103399 0
Room: 7.63, Level 7
School of Medicine and Dentistry
Griffith Health Building (G40)
Cnr Olsen Ave and
Parklands Dr
Southport QLD 4215
Country 103399 0
Australia
Phone 103399 0
+61 756780153
Fax 103399 0
Email 103399 0
[email protected]
Contact person for scientific queries
Name 103400 0
Santosh Kumar Tadakamadla
Address 103400 0
Room: 7.63, Level 7
School of Medicine and Dentistry
Griffith Health Building (G40)
Cnr Olsen Ave and
Parklands Dr
Southport QLD 4215
Country 103400 0
Australia
Phone 103400 0
+61 756780153
Fax 103400 0
Email 103400 0
[email protected]

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11068Study protocol  [email protected]
11069Informed consent form  [email protected]



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.