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.
