ANZCTR - Registration

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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

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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

dental caries

oral health literacy

dental hygiene

Condition category

Condition code

Oral and Gastrointestinal

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]

Behaviour

Intervention code [2]

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]

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]

One year after the last home visit (intervention).

Secondary outcome [1]

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]

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]

Chile

State/province [1]

Concepcion

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Fondo Nacional de Investigacion y Desarrollo en Salud. Comision Nacional de Investigacion Cientifica y Tecnologica.
Project: SA14ID0162.

Address [1]

Monedad 1375, Santiago de Chile.

Country [1]

Chile

Primary sponsor type

University

Name

Universidad de Concepcion.

Address

Roosevelt 1550, Concepcion.

Country

Chile

Secondary sponsor category [1]

Government body

Name [1]

Secretaria Regional Ministerial de Salud del Biobio.

Address [1]

O'Higgins 241, Concepcion.

Country [1]

Chile

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Comite de Bioetica, Facultad de Medicina, Universidad de Concepcion.

Ethics committee address [1]

Victor Lamas 1290, Concepcion.

Ethics committee country [1]

Chile

Date submitted for ethics approval [1]

Approval date [1]

13/10/2014

Ethics approval number [1]

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

Dr Ricardo Cartes-Velasquez

Address

Universidad de Concepcion School of Medicine. Roosevelt 1550, Concepcion.

Country

Chile

Phone

56-41-2204232.

Fax

rcartes@udec.cl

Contact person for public queries

Name

Ricardo Cartes-Velasquez.

Address

Universidad de Concepcion School of Medicine. Roosevelt 1550, Concepcion.

Country

Chile

Phone

56-41-2204232

Fax

rcartes@udec.cl

Contact person for scientific queries

Name

Ricardo Cartes-Velasquez

Address

Universidad de Concepcion School of Medicine. Roosevelt 1550, Concepcion.

Country

Chile

Phone

56-41-2204232

Fax

rcartes@udec.cl

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
19644	Study protocol	Cartes-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-2016-011819	rcartes@udec.cl

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	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.	2017	https://dx.doi.org/10.1136/bmjopen-2016-011819

N.B. These documents automatically identified may not have been verified by the study sponsor.

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