The Effectiveness of Educational Mobile Messages for Assisting in the Prevention of Early Childhood Caries: Protocol for a Randomized Controlled Trial.
BACKGROUND
In 2017, approximately 3.7 billion downloads of health apps were made on mobile phones and tablets. In this sense, a massive number of people could benefit by electronic mobile-based health interventions, making information available even with the lack of material and human resources. Hence, the use of electronic apps for dental education might be extremely useful for the prevention of early childhood caries (ECC).


OBJECTIVE
This study aims to evaluate the effectiveness of messages sent via mobile phones as an adjuvant method for the prevention of ECC.


METHODS
A single-blinded, randomized, and parallel-group clinical trial will be conducted with dyads of parents or caregivers and children aged between 36 and 60 months, recruited from kindergartens and schools of Bauru, São Paulo. The determination of sample size resulted in a total of 104 dyads of parents and children, considering a power of 80%, a significance level of 5%, and an attrition of 30%. This sample will be randomly assigned to test and control groups, being divided in 52 dyads per group according to the health literacy levels of parents and the age, gender, and oral health status of children. Every 2 weeks, only participants in the test group will receive messages via WhatsApp containing preventive and education-related ECC information. The dyads will visit the dentist every 3 months during a year for the assessment of primary outcomes (sugar consumption and the International Caries Detection and Assessment System, visible plaque, and community periodontal indices) and to receive dental care measures. Secondary outcomes (electronic health literacy and general perceived self-efficacy) will be determined only at baseline and after 12-month follow-up. The quality of randomization will be evaluated throughout the study, comparing the test and control groups systematically by Student t tests for continuous variables and chi-square tests for categorical variables. Listwise deletion method will be applied in cases of dropouts, if the missing values satisfy the criteria of missing completely at random; otherwise, multiple imputation data strategy will be conducted. The Kolmogorov-Smirnov and Levene tests will be used to determine the normality and homogeneity of data, respectively, which will indicate further statistical analyses for elucidating significant differences between groups (P<.05). A Student t test or Mann-Whitney U test will be employed for parametric or nonparametric analyses, respectively.


RESULTS
The project was funded in 2018, and enrollment was completed in August 2019. Allocation is currently under way and the first results are expected to be submitted for publication in 2020.


CONCLUSIONS
The results will contribute to understanding the importance of educational mobile messages toward the adoption of healthy behaviors for the prevention of ECC in a given population.


TRIAL REGISTRATION
Brazilian Registry of Clinical Trials Universal Trial Number U1111-1216-1393; http://www.ensaiosclinicos.gov.br/rg/RBR-2b6r7q/.


INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
PRR1-10.2196/13656.
['Aguirre|Patricia Estefania Ayala|PEA|http://orcid.org/0000-0001-6099-7664', 'Lotto|Matheus|M|http://orcid.org/0000-0002-0121-4006', 'Strieder|Anna Paola|AP|http://orcid.org/0000-0002-7033-0756', 'Cruvinel|Agnes Fátima Pereira|AFP|http://orcid.org/0000-0003-0612-9553', 'Cruvinel|Thiago|T|http://orcid.org/0000-0001-7095-908X']
randomized controlled trial dental caries eHealth