Efficacy of a Personalized Mobile Health Application in Improving Micronutrient Supplement Use among Pregnant Women in Karachi, Pakistan: A Parallel Group Randomized Controlled Trial (Preprint)

Abstract

BACKGROUND Micronutrient deficiencies in folate, ferritin, calcium, and vitamin D are common during pregnancy in developing countries, often due to insufficient dietary intake. Micronutrient supplementation could address this unmet need. Incorporation of novel awareness strategies in antenatal practices could potentially enhance compliance with supplement usage. OBJECTIVE We evaluated the efficacy of personalized mobile health (mHealth) intervention, hypothesizing a 30% improvement in supplement use in the intervention group compared to the conventional face-to-face counseling group. METHODS In an unblinded randomized controlled trial, we enrolled 306 first-trimester pregnant women from Aga Khan University Hospital between January 2020 and September 2021 who owned smartphones with internet connection and consented to participate. Women on regular medications, dietary restrictions, or suffering from critical illnesses were excluded. Intervention group received personalized coaching about micronutrient supplement use through an mHealth application named "PurUmeed Aaghaz" (Hopeful Beginning), as thrice-a-week push messages and tailored recommendations over a 24 weeks period. Comparison group received standard face-to-face counseling at 6, 12, 18, and 24 weeks post-enrollment. Baseline sociodemographic, obstetrics, anthropometric, and lifestyle data were collected through face-to-face interviews. At each follow-up, the weekly use of folic acid, iron, calcium, and vitamin D supplements was recorded and scored as 0 (daily), 1.5 (4-6 times weekly), and 3 (≤3 times weekly). These scores were summed to calculate the cumulative supplement use score (CSUS), ranging from 0-12, with higher scores indicating greater inadequacy. Further, every fourth woman was invited for biochemical assessment of micronutrient serum levels. Data were analyzed using STATA 14, with random effects linear and binary logistic panel regression to compare CSUS and each supplement usage between the two groups from baseline to end line. RESULTS Of 153 participants in each group, 107 (70%) in intervention and 125 (81.7%) in non-intervention group completed the study. After 24 weeks, intervention group showed a significantly greater reduction in mean CSUS compared to non-intervention group (β:-0.40, 95% CI:-0.79, -0.01). Daily supplement use improved by 20% vs. 22.4% for folic acid, 11.2 times vs. 2.1 times for iron, 1.2 times vs. 14.2 times for calcium, and 3 times vs. 1.3 times for vitamin D in intervention vs. non-intervention group, respectively. Multivariable analysis indicated higher odds of sufficient use of folic acid (aOR:1.14, 95% CI:0.63, 2.07), iron (aOR:1.41, 95% CI:1.06, 1.89), and vitamin D (aOR:1.97, 95% CI:1.51, 2.57) in intervention group, while calcium intake improved in non-intervention group (aOR:0.62, 95% CI:0.47, 0.81). At the end line, anemia decreased in intervention group, whereas deficiencies in ferritin, calcium, and vitamin D persisted or worsened, particularly in non-intervention group. CONCLUSIONS mHealth intervention, if adopted appropriately, can improve antenatal supplementation of iron and vitamin D. Affordable, accessible, and personalized counseling through mHealth can potentially ameliorate the micronutrient status during pregnancy. CLINICALTRIAL ClinicalTrials.gov NCT04216446