BACKGROUND
Adequate intake of macro and micronutrients and adoption of an active lifestyle during pregnancy are essential for optimum maternal and fetal health and offspring development. Dietary counselling and advice for adequate physical activity make integral components of antenatal care. Personalized coaching through the use of mobile health (m-Health) which supports behaviour modification is an innovative approach that needs exploration.
OBJECTIVE
Our primary objective is to assess the efficacy of an m-Health program in improving diet, supplement use and physical activity during pregnancy. Secondary objectives include evaluation of its effect on maternal and offspring health outcomes and assessment of its compliance and usability.
METHODS
A randomized control trial is initiated at the Aga Khan University Hospital, Karachi in January 2020. We aim to recruit 300 pregnant women in their first trimester having smartphones and without co-morbid or on medications. The intervention group would be trained to use an m-Health application named as PurUmeed Aaghaz. Through this application, the subjects would report information about their diet, supplement use and physical activity and would receive personalized advice and 3 push messages as weekly reminders. Research Assistant would obtain similar information from the non-intervention group on a paperless questionnaire who would receive standard face-to-face counselling on diet, supplement use and physical activity. Data would be collected at enrolment and on 4 follow-ups scheduled 6 weeks apart. Primary study outcomes include improvement in the diet (change in mean Dietary Risk Score (DRS) from baseline to each follow-up), supplement use (change in mean supplement use score and biochemical levels of folic acid, iron, calcium and vitamin D on a study subset) and mean duration of reported physical activity (minutes). Secondary study outcomes relate to maternal (gestational diabetes mellitus, gestational hypertension, preeclampsia and gestational weight gain), newborn (birth weight and length and gestational age at delivery) and infant health (body mass index and blood pressure at 1 year of age). Compliance would be determined by proportion completing coaching program at 6 months and usability would be assessed based on features related to design, interface, content, coaching, perception and personal benefit.
RESULTS
The study is approved by the Ethical Review Committee in 2017. As of June 01, 2021, 258 participants have been enrolled. Recruitment will be completed by July 2021 and results are expected to be released by early 2023.
CONCLUSIONS
This study will be an important step towards evaluating the role of m-Health in improving behaviours related to the consumption of healthy diet and supplement use, for promoting physical activity during pregnancy and in influencing maternal and offspring outcomes. If proven effective, m-health intervention can be scaled up and included in antenatal care package at tertiary care hospitals of Low Middle-Income Countries.
CLINICALTRIAL
Clinicaltrials.gov NCT04216446. Registered January 2, 2020.