JMIR Publications

ABSTRACT

Background:

In Pakistan, one third of under-five deaths (58/1000 live births) are attributable to high prevalence of stunting (40%), underweight (23%) and wasting (17.7%). Given the suboptimal prevalence of exclusive breast feeding (EBF) (48%) and alarmingly low consumption of minimum acceptable diet (3.6%), mitigation of early life nutritional risk provides a critical window of opportunity for intervention. Mobile health (mHealth) provides an innovative and low-cost option to improve Infant and Young Child Feeding Practices (IYCFPs) among mothers.

Objective:

The objective of this study is to assess efficacy of a context-specific mHealth coaching application in promoting EBF and IYCFPs compared to face-to-face counseling.

Methods:

This is a prospective, parallel-arm randomized controlled trial, planned at a secondary care hospital in Karachi, Pakistan. The study will enrol 300 booked singleton pregnant women in third trimester, who planned to stay in their respective areas for at least 1 year post delivery, registered for child immunization at associated Family Health Centre, own smartphones with internet access, be able to read Urdu, and provide consent. Participants in the intervention arm will receive Pehli Ghiza mHealth application along with routine standard of care face to face (F2F) counselling. The application will deliver context-specific educational content on BF and IYCFPs through short videos and messages, sent three times per week, tailored to the stage of pregnancy and infant age. Participants in the control arm will only receive routine F2F counselling. The standard of care will be delivered at each follow up scheduled at birth, 6, 10, and 14 weeks, and 6, 9, and 12 months of the infant’s age. Data will be collected at enrolment and at each follow-up visit using structured questionnaires. Primary outcomes are EBF and introduction to age-appropriate complementary feeding. Secondary outcomes include EIBF, continued BF at 1-year, minimum dietary diversity, minimum meal frequency, minimum acceptable diet, BF self efficacy and child health outcomes. Usability will be assessed based on features related to design, interface, content, coaching, perception, and personal benefit. Analysis will follow the intention-to-treat principle to detect a 20% absolute improvement in primary outcomes between the intervention and control groups over time to evaluate between-group differences in feeding practices.

Results:

The study is approved by the Ethics Review Committee of the Aga Khan University and National Ethics Committee. Participant recruitment is planned to start in February 2026. Follow-ups and outcome assessments are expected to be completed by May 2027, and analysis is expected to be completed by September 2027. We expect the results to be published by the end of 2027.

Conclusions:

This study is first randomized controlled trial in Pakistan to evaluate the efficacy of a culturally tailored mHealth application in promoting EBF and age-appropriate IYCFPs. If effective, the Pehli Ghiza intervention could support the integration of digital health tools into standard of care in Pakistan and similar low- and middle-income country settings. Clinical Trial: NCT05590351