The Efficacy of a Personalized mHealth Coaching Program During Pregnancy on Maternal Diet, Supplement Use, and Physical Activity: Protocol for a Parallel-Group Randomized Controlled Trial
Authors: Nuruddin Rozina , Vadsaria Khadija , Mohammed Nuruddin , Sayani Saleem 
Published: September 2021

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 counseling and advice regarding adequate physical activity are integral components of antenatal care. Personalized coaching through the use of mobile health (mHealth) that supports behavior modification is an innovative approach that needs exploration.

Objective
Our primary aim is to assess the efficacy of an mHealth program in improving diet, supplement use, and physical activity during pregnancy. Secondary objectives include evaluation of the program’s effect on maternal and offspring health outcomes and assessment of its compliance and usability.

Methods
A randomized controlled trial was initiated at the Aga Khan University Hospital in Karachi, Pakistan, in January 2020. We aim to recruit 300 pregnant women in their first trimester who have smartphones, do not have comorbidities, and are not taking medications. The intervention group will be trained to use an mHealth app called PurUmeed Aaghaz. Through this app, the subjects will report information about their diet, supplement use, and physical activity and will receive personalized advice and three push messages as weekly reminders. The research assistant will obtain similar information from the control group via a paperless questionnaire; this group will receive standard face-to-face counseling regarding diet, supplement use, and physical activity. Data will be collected at enrollment and during four follow-up sessions scheduled 6 weeks apart. Primary study outcomes include improvements in diet (ie, change in mean dietary risk score from baseline to each follow-up), supplement use (ie, changes 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 health (ie, gestational diabetes mellitus, gestational hypertension, pre-eclampsia, and gestational weight gain), newborn health (ie, birth weight and length and gestational age at delivery), and infant health (ie, BMI and blood pressure at 1 year of age). 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 in 2017. The recruitment of study participants was completed in September 2021. All follow-ups and outcome assessments are expected to be completed by March 2023 and analysis is expected to be completed by June 2023. We expect the results to be published by the end of 2023.

Conclusions
This study will be an important step toward evaluating the role of mHealth in improving behaviors related to a healthy diet, supplement use, and promotion of physical activity during pregnancy, as well as in influencing maternal and offspring outcomes. If proven effective, mHealth interventions can be scaled up and included in antenatal care packages at tertiary care hospitals of low- and middle-income countries.

Trial Registration
ClinicalTrials.gov NCT04216446; https://clinicaltrials.gov/ct2/show/NCT04216446

International Registered Report Identifier (IRRID)
DERR1-10.2196/31611