Innovative mHealth Intervention providing Sustained Anticipatory Guidance (Zero Cavity): Design, Validation, User Perception, and Effectiveness

Project Summary Early Childhood Caries (ECC), though preventable is the second most common chronic disease of childhood. Recently, digital health has attracted substantial interest from the government particularly in low-middle-income countries (LMIC) where mobile communication and telehealth has opened new possibilities for overcoming the geographical inaccessibility of health care. Our preliminary work at the Centre for Early Childhood Caries Research (CECCRe) using telephone calls, text messages, and providing age-appropriate infant oral care aids collectively called Sustained Anticipatory Guidance (SAG) has shown promising results in infants with cleft lip and palate recruited at pre dentate stage in preventing ECC. The feasibility and success of SAG have led to ECC prevention up to 94%. We, therefore, propose to develop, validate, and test a novel approach of using a mobile app to provide age-appropriate SAG to the parents. This approach is fundamentally different from the traditional method of providing anticipatory guidance (AG) at the 6-monthly recall visits. In the R21 phase, we will develop and test an interactive mobile app (Zero Cavity), grounded in Fisher Owen's model of children's oral health determinants and the theory of planned behavior. Semi-structured interviews and focus group discussion to explore awareness and practices and perceptions of oral health with relevant stakeholder groups of parents, pediatricians and dentists and develop tailored guidance to the infant!s age and specific state of oral development. We will use Design Thinking, 5De approach, and Nielsen Norman Guidelines to develop the Zero cavity app prototype. In Aim 2, we will pilot test the Android and iOS versions of the app and evaluate user perception using uMARS, CALO-RE scales. The R33 phase will be undertaken after the successful completion of the R21 milestones. In Aim 3, we will establish 540 mother-child dyads and using an intent-to- treat analysis to determine the effect of mobile app-assisted SAG protocol delivered through the Zero Cavity app. Both intervention and control groups will receive baseline AG at the initial visit and at in-person 6-monthly recalls. In addition, intervention group will receive SAG through the Zero cavity app between the in-person visits. The trial will be carried out after registration in Clinical Trial Registry-India (CTRI) and adhering to CONSORT guidelines. The R33 phase will culminate with an evaluation of effectiveness of the Zero Cavity app in delivering SAG to mothers/fathers, thereby, preventing ECC. The secondary outcome (occurrence of ECC) will be measured using International Caries Detection and Assessment System (ICDAS) by calibrated examiners at 6 monthly intervals. The overall goal of this study is to develop, validate and test an interactive mobile app (Zero Cavity) to deliver SAG to parents leading to a scalable cost-effective intervention preventing ECC in LMIC countries.