Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000205730
Ethics application status
Approved
Date submitted
8/12/2021
Date registered
7/02/2022
Date last updated
30/11/2023
Date data sharing statement initially provided
7/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Infant2Child: Observational dental health study evaluating the effect of early life influences on tooth decay in children aged 4
Scientific title
Infant2Child: Observational dental health study evaluating the effect of sugar, toothbrushing, oral microbiome and an early life nutrition intervention (INFANT) on dental caries in children aged 4
Secondary ID [1] 305989 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This registration is an observational study which includes a cohort of participants recruited from study ACTRN12620000670976.

Health condition
Health condition(s) or problem(s) studied:
Dental caries 324610 0
Condition category
Condition code
Oral and Gastrointestinal 322062 322062 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
One part of this study involves a follow-up of an existing early life intervention study, Infant to Scale (ACTRN12620000670976). The INFANT program provides early life health promotion through face-to-face group sessions and the My Baby Now app. The program includes four 1.5 - 2hour face-to-face sessions at infant age 3, 6, 9, 12 months, delivered by trained service providers (typically MCH nurses or dietitians) in local government areas delivering INFANT. Sessions focus on anticipatory guidance to enhance parental knowledge, skills, and social support around infant feeding, diet, active play, and sedentary behaviours to encourage healthy habits from the very start of life. The smart-phone app/website (My Baby Now) has been developed to complement face-to-face delivery by providing ‘around the clock’, high-quality information and personalised/tailored support. The app provides guidance on breastfeeding, best practice formula feeding and sleep as well as early oral health habits such as toothbrushing and timely dental check-ups.

The oral health promotion is not in addition to the INFANT program - it refers to information/messaging that is provided as part of the My Baby Now App.

A second cohort of children will be recruited from Early Childcare Centres in Victoria. The study will not be providing participants in this cohort any intervention. Additional measures will be collected from this cohort to measure household level disadvantage.

All participants will be evaluated at two time points: 2 and 4 years of age. At 2 years of age, participants will collect an at-home plaque microbiome sample and complete 2 questionnaires (general medical and dental and parent reported quality of life, food frequency). At 4 years of age participants will be measured for height and weight, complete an additional 2 questionnaires (general medical and dental and parent reported quality of life, food frequency) and attend a dental examination where an oral health practitioner will also collect an additional plaque microbiome swab.
Intervention code [1] 322384 0
Not applicable
Comparator / control treatment
The comparison group in the first arm of the study will be recruited from the Infant to Scale study (ACTRN12620000670976). Participants will be recruited at the same age and will not have received any face to face sessions nor engaged with the app. The comparison group will receive standard care, for example maternal child health.
Control group
Active

Outcomes
Primary outcome [1] 329830 0
Presence and severity of dental caries using the International Caries Detection and Assessment System (ICDAS).
Timepoint [1] 329830 0
4 years of age
Primary outcome [2] 329964 0
Number of decayed, missing and/or filled surfaces and teeth using the International Caries Detection and Assessment System (ICDAS).
Timepoint [2] 329964 0
4 years of age
Secondary outcome [1] 403990 0
Sugar consumption quantified through the validated INFANT food frequency questionnaire.
Timepoint [1] 403990 0
2 and 4 years of age
Secondary outcome [2] 404471 0
Toothbrushing frequency quantified through a dental and general medical questionnaire using a questionnaire designed specifically for this study
Timepoint [2] 404471 0
2 and 4 years of age

Eligibility
Key inclusion criteria
Each participant must meet all of the following criteria to be enrolled in this study:
• Children at least 18 months of age
• Completed the online informed consent form and has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant’s behalf
Minimum age
18 Months
Maximum age
24 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants meeting any of the following criteria will be excluded from this study:
• Children or parent/guardian with intellectual impairment who cannot give informed consent
• Families whose level of English precludes adequate understanding to be able to give informed consent without the use of an interpreter

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Analysis will estimate the effect of key exposures (INFANT, toothbrushing, sugar intake, and oral microbiome) on dental caries, dietary and toothbrushing outcomes at 4 years, adjusted for the key confounder of social disadvantage (low levels of maternal education) as well as other potential confounders and any baseline differences between intervention and comparison groups. To obtain confounding-adjusted estimates we will use appropriate multivariable regression models for the outcomes. Specifically, we will use binomial and zero-inflated Poisson multivariable regression models for the primary outcomes (1) presence/absence of dental caries at 4 years, and (2) number of decayed, missing and/or filled surfaces and teeth, respectively. The relative risk estimated from the regression models provides an estimate of the effect of interest, comparing the outcome with versus without the intervention. The same approach will be used for secondary outcomes using regression models appropriate to the outcome type (e.g. linear regression for continuous outcomes). Potential selection bias due to missing data or loss to follow up will be minimised using multiple imputation by chained equations.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/02/2022
Actual
8/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
3000
Accrual to date
260
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 310330 0
Government body
Name [1] 310330 0
Australian Department of Health - Medical Research Future Fund
Country [1] 310330 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Murdoch Children's Research Institute
Address
50 Flemington Road, Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 311457 0
None
Name [1] 311457 0
None
Address [1] 311457 0
None
Country [1] 311457 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309990 0
Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 309990 0
Ethics committee country [1] 309990 0
Australia
Date submitted for ethics approval [1] 309990 0
30/11/2021
Approval date [1] 309990 0
28/01/2022
Ethics approval number [1] 309990 0

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

Contacts
Principal investigator
Name 116098 0
Dr Mihiri Silva
Address 116098 0
Murdoch Children's Research Institute
50 Flemington Road
Parkville VIC 3052
Country 116098 0
Australia
Phone 116098 0
+61 3 9933 5162
Fax 116098 0
Email 116098 0
[email protected]
Contact person for public queries
Name 116099 0
Mihiri Silva
Address 116099 0
Murdoch Children's Research Institute
50 Flemington Road
Parkville VIC 3052
Country 116099 0
Australia
Phone 116099 0
+61 3 9933 5162
Fax 116099 0
Email 116099 0
[email protected]
Contact person for scientific queries
Name 116100 0
Mihiri Silva
Address 116100 0
Murdoch Children's Research Institute
50 Flemington Road
Parkville VIC 3052
Country 116100 0
Australia
Phone 116100 0
+61 3 9933 5162
Fax 116100 0
Email 116100 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
14361Study protocol    Not currently available but will eventually be pub... [More Details]



Results publications and other study-related documents

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