Efficacy of a Mobile Health App in Promoting Breastfeeding and Young Child Feeding Practices in Pakistan: Protocol for a Randomized Controlled Trial.

Background: In Pakistan, one-third of under-5 deaths (58/1000 live births) are attributable to the high prevalence of stunting (40%), underweight (23%), and wasting (17.7%). Given the suboptimal prevalence of exclusive breastfeeding (EBF; 48%) and the alarmingly low consumption of a 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: This study aims to assess the efficacy of a context-specific mHealth coaching app in promoting EBF and IYCFPs compared to face-to-face (F2F) counseling. Methods: This is a prospective, parallel-arm randomized controlled trial planned at a secondary care hospital in Karachi, Pakistan. The study will enroll 300 booked singleton pregnant women in the third trimester, who plan to stay in their respective areas for at least 1 year postdelivery, are registered for child immunization at the associated Family Health Center, own smartphones with internet access, are able to read Urdu, and provide consent. Participants in the intervention arm will receive the Pehli Ghiza mHealth app along with routine standard-of-care F2F counseling. The app will deliver context-specific educational content on breastfeeding and IYCFPs through short videos and messages sent 3 times per week, tailored to the stage of pregnancy and infant age. Participants in the control arm will receive only routine F2F counseling. The standard of care will be delivered at each follow-up visit, which is scheduled at birth, at 6, 10, and 14 weeks, and at 6, 9, and 12 months of the infant's age. Data will be collected at enrollment and at each follow-up visit using structured questionnaires. Primary outcomes are EBF and the introduction of age-appropriate complementary feeding. Secondary outcomes include early initiation of breastfeeding, continued breastfeeding at 1 year, minimum dietary diversity, meal frequency, minimum acceptable diet, and child health outcomes. 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 and to evaluate between-group differences in feeding practices. Compliance will be determined by the proportion of participants who complete the 6-month coaching program. Usability will be assessed based on features related to design, interface, content, coaching, perception, and personal benefit. Results: The study was approved by the Ethics Review Committee of the Aga Khan University and the National Ethics Committee. Participant recruitment started on February 2, 2026. As of May 18, 2026, 241 participants have been recruited. Follow-ups and outcome assessments are expected to be completed by June 2027. Conclusions: 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.