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Trial registered on ANZCTR


Registration number
ACTRN12615000450516
Ethics application status
Approved
Date submitted
22/04/2015
Date registered
8/05/2015
Date last updated
10/07/2023
Date data sharing statement initially provided
10/07/2023
Date results information initially provided
10/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a motivational interview strategy to improve oral health literacy and morbidity compared to traditional oral health promotion in disadvantaged families.
Scientific title
Evaluation of a motivational interview strategy to improve oral health literacy and morbidity compared to traditional oral health promotion in disadvantaged families.
Secondary ID [1] 286574 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dental caries 294831 0
oral health literacy 294834 0
dental hygiene 294835 0
Condition category
Condition code
Oral and Gastrointestinal 295106 295106 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
Four to six home visits by dental assistants previously trained in motivational interview covering oral health.
Motivational interview involves an initial assessment about dental care (hygiene and other habits), according to this assessment the dental assitants will motivate to change behaviors using techniques like: identifying the problems of the patients, reflective listening, open ended questions, summary statements, and providing affirmations.
The complete procedure takes 3 to 6 weeks. The frequency of visits is one per 7-to-14 days.
The mode of administration includes (by invitation) to all members of families (parents, children and other adults) present in the house at the moment of the visit.
Preschool children from this families receive dental education in their kindergarten.
Intervention code [1] 291689 0
Behaviour
Intervention code [2] 291690 0
Lifestyle
Comparator / control treatment
Preschool children from this families receive dental education in their kindergarten. Dental education is delivered in each kindergarten following the guidelines of Ministry of Health.
Control group
Active

Outcomes
Primary outcome [1] 294867 0
Dental caries incidence. The examination will be performed on Universidad de Concepcion School of Dentistry using the International Caries Detection and Assessment System.
Timepoint [1] 294867 0
One year after the last home visit (intervention).
Secondary outcome [1] 314260 0
Oral health literacy. The examination will be performed on Universidad de Concepcion School of Dentistry using the Oral Health Literacy Index and the Rapid Estimate of Adult Literacy in Dentistry.
Timepoint [1] 314260 0
one year after the last home visit (intervention).

Eligibility
Key inclusion criteria
Preschool children from deprived families from Province of Concepcion in Chile.
Preschool children attending public kindergarten.
Minimum age
2 Years
Maximum age
4 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Preschool children under large dental treatments.
Preschool children with intellectual disability parents and/or caregivers.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This is a community trial, two areas from province of Concepción were selected to participate.
Boca Sur will be the intervention group and Los Cerros will be the control group.
Parents from preschool children attending the public kindergarten in this areas will be invited to participate as intervention or control.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
None.
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
Intervention and control group are geogrpahically separated by 25 km.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size: Was considered values based on the incidence of caries in Chilean preschoolers. The calculation was performed in four steps:
1. T test for two independent samples (two-sided test, alpha = 5%, power = 80% , minimum of 2 units to detect difference, assuming a common standard deviation of 4.00) to give an ni equal to 64 preschoolers.
2. The design effect associated with random assignment of groups was calculated as follow: 1 + (ni - 1) * (intragroup correlation coefficient = 0.01) equal to 1.63.
3. The loss rate was estimated in 15%..
4. Finally the required sample is 64 * 1,63 * 1,15 equal to 120 preschoolers per group.

Statistical analysis: Univariate description of all variables (baseline and follow-up) will be performed using frequency tables (qualitative variables), summary measures (of central tendency and dispersion for quantitative variables), accompanied by relevant graphics (pie charts, bars and histograms).
Regarding the psychometric properties of OHLI and REALD-30, the Cronbach’s alpha coefficient for internal consistency of the scales will be used. Regarding the calibration of the dentists and social workers, the strength of agreement will be determined with Kappa or Lin coefficients, depending on the nature of the variables.
To analyse the association between qualitative variables, the ?2 test will be used and for the association of quantitative variables, the Pearson correlation coefficient. To compare the incidence of caries and changes in the level of OHL (intervention effect), the analysis of covariance and multiple linear regression models will be used. In both cases, relevant confounding variables will be considered: sex, parents’ age, parents’ education level, child’s age, monthly per capita income and baseline values for caries and OHL. If the necessary assumptions for parametric tests are not met, the corresponding non-parametric tests will be used.
Statistical significance will be set at p<0.05. The analysis will be made with Stata/SE V.14 for Windows (StataCorp, Texas, USA).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/05/2015
Actual
11/05/2015
Date of last participant enrolment
Anticipated
31/08/2015
Actual
15/11/2015
Date of last data collection
Anticipated
Actual
8/03/2017
Sample size
Target
240
Accrual to date
Final
240
Recruitment outside Australia
Country [1] 6838 0
Chile
State/province [1] 6838 0
Concepcion

Funding & Sponsors
Funding source category [1] 291137 0
Government body
Name [1] 291137 0
Fondo Nacional de Investigacion y Desarrollo en Salud. Comision Nacional de Investigacion Cientifica y Tecnologica.
Project: SA14ID0162.
Country [1] 291137 0
Chile
Primary sponsor type
University
Name
Universidad de Concepcion.
Address
Roosevelt 1550, Concepcion.
Country
Chile
Secondary sponsor category [1] 289816 0
Government body
Name [1] 289816 0
Secretaria Regional Ministerial de Salud del Biobio.
Address [1] 289816 0
O'Higgins 241, Concepcion.
Country [1] 289816 0
Chile

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292714 0
Comite de Bioetica, Facultad de Medicina, Universidad de Concepcion.
Ethics committee address [1] 292714 0
Victor Lamas 1290, Concepcion.
Ethics committee country [1] 292714 0
Chile
Date submitted for ethics approval [1] 292714 0
Approval date [1] 292714 0
13/10/2014
Ethics approval number [1] 292714 0
EI/28/2014

Summary
Brief summary
The aim of this project is to determine the health impact measured by the incidence of caries and literacy levels in oral health after 12 months of an intervention in oral health promotion through the motivational interview compared to the traditional way to deliver oral health promotion in kindergarten.
An experimental community trial is proposed in two urban areas of low socioeconomic status in the province of Concepcion: Los Cerros in Talcahuano and Boca Sur in San Pedro de la Paz. Both sectors are covered by public kindergartens (JUNJI or INTEGRA) that promote oral health in traditional ways (TW). The promotion intervention in households consist of 4 to 6 visits by a dental assistant previously trained for two months in the delivery of a standardized oral health promotion through the technique of motivational interviewing (MI).
The experimental group will receive TW and MI, whereas the control group only TW. If it is found a positive and significant effect of MI, this will be administered to the control group. For a 50% reduction in the incidence of caries a sample size of 120 preschoolers per group was estimated.
The project involves the implementation of activities spread over 7 phases to develop during the 24 months, as follows: 1. Preparation of the team; 2. Measurement of baseline data; 3. Implementation of the intervention; 4. Waiting Period; 5. Measurement of post-intervention data; 6. Analysis of the data; and 7. Generation products.
The outcome variables assessed at follow-up corresponding to the difference in the experimental and control groups in the incidence of caries in preschool and change in oral health literacy of parents and/or caregivers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56506 0
Dr Ricardo Cartes-Velasquez
Address 56506 0
Universidad de Concepcion School of Medicine. Roosevelt 1550, Concepcion.
Country 56506 0
Chile
Phone 56506 0
56-41-2204232.
Fax 56506 0
Email 56506 0
rcartes@udec.cl
Contact person for public queries
Name 56507 0
Dr Ricardo Cartes-Velasquez.
Address 56507 0
Universidad de Concepcion School of Medicine. Roosevelt 1550, Concepcion.
Country 56507 0
Chile
Phone 56507 0
56-41-2204232
Fax 56507 0
Email 56507 0
rcartes@udec.cl
Contact person for scientific queries
Name 56508 0
Dr Ricardo Cartes-Velasquez
Address 56508 0
Universidad de Concepcion School of Medicine. Roosevelt 1550, Concepcion.
Country 56508 0
Chile
Phone 56508 0
56-41-2204232
Fax 56508 0
Email 56508 0
rcartes@udec.cl

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The informed consent explicitly specifies that the data collected will be utilized solely for the purpose of this particular research project, with no indication or disclosure made regarding any alternative utilization of the data to the patients.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19644Study protocolCartes-Velasquez R, Araya C, Flores R, Luengo L, Castillo F, Bustos A. A motivational interview intervention delivered at home to improve the oral health literacy and reduce the morbidity of Chilean disadvantaged families: a study protocol for a community trial. BMJ Open. 2017 Jul 13;7(7):e011819. doi: 10.1136/bmjopen-2016-011819. PMID: 28710202; PMCID: PMC5577873. https://doi.org/10.1136%2Fbmjopen-2016-011819rcartes@udec.cl



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA motivational interview intervention delivered at home to improve the oral health literacy and reduce the morbidity of Chilean disadvantaged families: A study protocol for a community trial.2017https://dx.doi.org/10.1136/bmjopen-2016-011819
N.B. These documents automatically identified may not have been verified by the study sponsor.