Protocol of a Randomized Control Trial to Reduce Screen-Time among children aged two to five years in Chandigarh, a North Indian Union Territory (Preprint)
BACKGROUND Excessive digital-screen exposure (more than equal to one hour per day) is associated with children's low growth and development. OBJECTIVE To develop and assess a multi-component intervention program's effectiveness to reduce excessive screen-time among children of age two to five years. METHODS A theory-based multi-component intervention known as Program to Lower Unwanted Media Screens (PLUMS) at the household level will be developed. It is based on the social cognitive theory for children and self-determination theory for caregivers. A randomized control trial will be conducted to assess this intervention's effectiveness among healthy children aged 2-5 (±3 months) years and their primary-caregivers having at least one digital-media gadget at home in zone three of Chandigarh (population of 2,73,035), after pretesting. A sample size of 428 children is estimated per arm. PLUMS includes disseminating specific information, education, communication in the form of videos and posters to the primary caregivers and conducting motivational interviewing as and when needed. Children will be suggested playful activities as alternatives to digital-media gadgets. The primary outcome is the mean change in the duration of screen-time and secondary outcomes are sleep duration and patterns, emotional-behavioral problems, and the level of physical activity of the children. Per protocol and intention to treat analysis will be done using IBM SPSS Statistics for Macintosh, Version 25.0. RESULTS The intervention package will be disseminated once a week for eight weeks to the participants via preferred means of communication of the caregivers. The end line assessment will be done post-intervention immediately and after the six months of follow-up. Institute's ethics committee, Postgraduate Institute of Medical Education and Research, Chandigarh, India, had approved this study. (INT/IEC/2019/000711). The Indian Council of Medical Research, New Delhi (3/1/3/Next-100/JRF-2015/HRD), and PGIMER, Chandigarh (71/2-Edu-16/92, Dated 08/01/2018) has funded this study. CONCLUSIONS A Program to Lower Unwanted Media Screens (PLUMS) might be effective in reducing the excessive screen time among children age two to five years in a North Indian Union Territory. CLINICALTRIAL The trial has been registered in Clinical Trial Registry India (CTRI/2017/09/009761) available on http://ctri.nic.in/Clinicaltrials/advsearch.php.