Effects of an mHealth voice message service (mMitra) on maternal health knowledge and practices of low-income women in India: Findings from a pseudo-randomized controlled trial

Background: Mobile Health (mHealth) is becoming an important tool to improve health outcomes in maternal, newborn and child health (MNCH). Studies of mHealth interventions, have demonstrated their effectiveness in improving uptake of recommended maternal services such as antenatal visits. However, evidence of impact on maternal health outcomes is still limited. Methods: A pseudo-randomized controlled trial (single blind) was conducted to assess the impact of a voice-message based maternal intervention on maternal health knowledge, attitudes, practices and outcomes over time: Pregnancy (baseline/Time 1); Post-partum (Time 2) and when the infant turned one year old (Time 3). Women assigned to the mMitra intervention arm received gestational age- A nd stage-based educational voice messages via mobile phone in Hindi and Marathi, while those assigned to the control group did not. Both groups received standard care. Results: Two thousand sixteen women were enrolled. Interviews were conducted with 1516 women in the intervention group and 500 women in the control group at baseline and post-partum. The intervention group performed significantly better than controls on four maternal health practice indicators: Receiving the tetanus toxoid injection (OR: 1.6, 95% Confidence Interval (CI): 1.05-2.4, p = 0.028), consulting a doctor if spotting or bleeding (OR: 1.72, 95%CI: 1.07-2.75, p = 0.025), saving money for delivery expenses (OR: 1.79, 95%CI: 1.38-2.33, p = 0.0001), and delivering in hospital (OR: 2.5, 95%CI: 1.49-4.35, p = 0.001). The control group performed significantly better than the intervention group on two practice indicators: Resting regularly during pregnancy (OR: 0.7, 95%CI: 0.54-0.88, p = 0.002) and having at-home deliveries attended by a skilled birth attendant (OR: 0.46, 95%CI: 0.23-0.91, p = 0.027). Both groups’ knowledge improved from Time 1 to Time 2. Only one knowledge indicator, on seeking medical care during pregnancy, was statistically increased in the intervention group compared to controls. Anemia status at or near the time of delivery was unable to be assessed due to missing data from maternal health cards. Conclusions: This study provides evidence that in low-resource settings, mobile voice messages providing tailored and timed information about pregnancy can positively impact maternal health care practices proven to improve maternal health outcomes. Additional research is needed to assess whether voice messaging can motivate behavior change better than text messaging, particularly in low literacy settings. Trial registration: The mMitra impact evaluation is registered with ISRCTN under Registration # 88968111, assigned on 6 September 2018 (See https://www.isrctn.com/ISRCTN88968111). From January 2015 to December 2017, a pseudo-randomized controlled trial was conducted to evaluate the impact of mMitra. mMitra is the India country program affiliated with the Mobile Alliance for Maternal Action (MAMA), a 4-year global initiative that focused on improving the health and wellbeing of pregnant women and their newborns and infants through mobile phone delivered age- and stage-based tailored voice or text messages [7]. Through support from MAMA, the non-profit Advancing Reduction in Mortality and Morbidity of Mothers, Children and Neonates (ARMMAN), designed and implemented a mobile phone voice messaging service called mMitra. The overall Theory of Change aligned mobile messaging on key topics with prioritized health outcomes [7, 9]. mMitra aimed to help pregnant women improve self-care and uptake of key MNCH services during pregnancy through the first year of their children’s lives, primarily through behavior change. To date, the program has been implemented in nine states in India and has reached over 2 million women [9]. In the impact evaluation, a series of three questionnaires were administered to assess change in knowledge and uptake of practices known to improve maternal health outcomes in addition to acceptance of the mMitra intervention with a targeted focus on urban slums in Mumbai, India. This impact evaluation is registered with the ISRCTN (Trial# 88968111). Mumbai has 27 municipal wards, or administrative units, each with a population of roughly 800,000-900,000. Each ward is typically served by one maternity home and five or six health posts that provide pregnancy and infant health care services. Each ward appoints approximately 100 Angan Wadi Workers (AWWs) who make home visits, register pregnant women and motivate them to seek mother and child care. For this study, two such wards (F North and M East) were purposely selected for their large area, high population density and lack of prior exposure to mMitra. Researchers, who functioned independently of the AWWs, canvassed the wards to identify pregnant women for enrollment in the study. Pregnant women in the two wards who spoke Hindi or Marathi – languages spoken by over 80% of the population in the city – were identified by research team members. The team members then followed up with eligible women to inform them of the study, obtain voluntary consent and enroll and assign them to the intervention or control group. Women without access to a mobile phone at home and not likely to be in Mumbai for 4–5 months during the pregnancy and after delivery (i.e., those planning to visit natal homes outside Mumbai for delivery, a common cultural practice in India) were not enrolled in the study. The sample selection was single blind. At the time of enrollment, all women gave informed written consent prior to inclusion in the study and were not made aware of whether they were included in the intervention or the control group. Assignment to the intervention or control group was based on time of enrollment. For every 4 women consecutively enrolled in the study, the first 3 were assigned to the intervention group and the remaining woman was assigned to the control group. This approach was used in an attempt to ensure sufficient numbers of women were enrolled based on gestational age or pregnancy trimester to test the hypothesis that longer exposure to the messages would have an effect on outcomes (dose response) as the messages are designed to be delivered to coincide with the specific stage of the pregnancy. No other interventions were introduced alongside the messages. There was no known information contamination that was identified in the study. Women assigned to the intervention and control groups were followed by the investigators throughout their pregnancy until their infants turned one year of age. The intervention group received the mMitra voice messages in Hindi or Marathi, and the control group did not receive messages at all. One hundred and forty-five audio messages comprised the mMitra call package. The messages were designed by BabyCenter [10], adapted to local practices in partnership with ARMMAN and representatives from the Federation of Obstetric and Gynecological Societies of India and the Indian Academy of Pediatrics, and based on global (World Health Organization) and local (National Health Mission) guidelines. The audio messages were timed to the gestational age and developmental stage of the fetus and infant, respectively. They covered content relevant to women from when they were 6 weeks pregnant until their child reached 1 year of age. Specifically, this included nutrition, iron/folic acid supplementation, calcium supplements, development of the fetus, ANC reminders, anemia, rest during pregnancy, blood tests, HIV testing, sonography, danger signs during pregnancy, birth preparedness, identifying labor pains, cutting the umbilical cord/dressing the stump, family planning, sanitation and hygiene, breastfeeding practices, colostrum, and sex determination. The messages were designed to be delivered two times per week during pregnancy. However, they were clustered at one message per day immediately post-partum for a week, and then reduced back to two messages per week until the child completed 1 year [9]. In case women missed messages, they could initiate a free call-back service within 2 days of the original call. The messages, as well as their audio translations into Hindi and Marathi, were tested for appropriateness and cultural nuances with local health experts and through in field focus group studies. The voice and tone of the female recording artist were field-tested. The final message product was roughly 2 min long. The message began with a recognizable ‘jingle’ to alert the woman and her family; it ended by summarizing the key learning point. The sampling approach and sample size estimates were selected to ensure representativeness of the study population to the target population. The sample size was determined using a two-sample z proportion test. Sample size estimates were calculated for the primary outcome of interest: reduction of anemia during pregnancy. The District Level Household and Facility Survey 4 for urban poor in Maharashtra estimates the prevalence of anemia in pregnancy at 68.5% [11]. The sample size needed to detect a 10% reduction in anemia, assuming 30% attrition at an alpha of 0.05 and 80% power, was 392 per arm. There were three rounds of data collection during this study: Pregnancy (baseline/Time 1); Post-partum (Time 2) and when the infant turned 1 year old (Time 3). There were no maternal health outcomes or indicators collected at Time 3. Satisfaction with the mMitra service for women receiving the service was assessed through a series of questions using a 5-point Likert scale. Data were collected by six female investigators who were part of the research team and went from house-to-house. During the baseline period (Time 1), the investigators visited 100–110 homes per day in an attempt to enroll 4–5 women. Women who agreed to enroll in the study signed a consent form. They were then allocated either to the intervention or control group based on their time of enrollment. They then completed a survey administered orally by the investigator in either Hindi or Marathi – based on participant preference. The Time 1 Survey Questionnaire has been included as Supplementary Material S1-First interview mMitra. Their response was recorded on an Android tablet using the Kobo Collect platform. In the event of connectivity issues or low battery, the investigator filled out a paper-based form and entered the data into the tablet later that same day. At the end of each day, the investigators submitted their tablets to their supervisors. The supervisors reviewed the surveys and uploaded the data onto the central server. Every day, a data manager examined the uploaded data for completeness and consistency in responses. Any problems identified were discussed in daily morning briefings with the research team and addressed. The subsequent rounds of interviews were completed in the same manner. In addition to the interviews, the investigators copied clinical information from the Mother and Child Health (MCH) card into the Kobo Collect platform. The MCH card is routinely issued to each woman at the health facility. The card contains information on services provided and clinical/laboratory findings (e.g., weight, blood pressure, hemoglobin level) of the woman and the child until the child reaches 1 year of age. Information on maternal health knowledge and attitudes were collected at Times 1 and 2 through surveys. Data on maternal health outcomes were collected at Time 2 through surveys and MCH cards. In the intervention group, experience with mMitra was assessed at Time 2 through a semi-structured questionnaire. The Time 2 Survey Questionnaire has been included as Supplementary Material S2- Second interview mMitra. In terms of study compliance, of the original 2016 women enrolled, 1760 women (87%) were reached for Time 2 interviews. 256 (13%) women could not be interviewed because some had gone to their mother’s house for delivery and had not returned home at the time of the interview held within 2 weeks after delivery (many of them had subsequently returned home and participated in Time 3 interviews when child health information was sought). Five women were reached but refused to be interviewed at Time 3. The primary outcome of interest was anemia reduction. The data for this outcome were obtained at Time 2 and sourced from both the survey and triangulating with their MCH cards. It was selected for its clinical importance (e.g., low birth weight, premature birth, and maternal mortality) and prioritization by the Government of India for intervention. The hemoglobin level measured closest and prior to her date of delivery was used and obtained during Time 2. The data source was the MCH card. Hemoglobin levels greater than 110 g per Liter (g/L) were considered normal and indicative of the absence of anemia. There were several additional outcomes of interest, including maternal health seeking knowledge, attitudes and practices. Most of the indicators related to maternal health seeking and care were included in the first two survey rounds (Times 1 and 2). Women’s responses to questions on proven ANC and post-natal care practices were compared at Times 1 and 2 and then in the intervention group versus control group. First, descriptive analyses were conducted to obtain a general sense of the data. Continuous data were compared between the intervention and control groups using two-sample t-test. When comparing continuous data from Times 1 and 2 across groups, the two-paired t-test was used. Categorical outcomes were assessed using chi-square tests. For the outcomes data, simple and binary logistic regressions were conducted. Intention to treat and per protocol analyses were conducted and compared. All data were analyzed using SPSS version 18.0. The study was approved by the Foundation for Research in Health Systems’ Institutional Review Board under Protocol Number HHS00009235. Written informed consent was obtained from all participants.