Development and Pilot Test of an mHealth Interactive Education and Social Support Intervention for Improving Postnatal Health - Phase 1
Phase: NA
Conditions: Health Attitude, Knowledge, Attitudes, Practice, Postpartum Depression, Acceptability of Health Care
Sponsor: University of California, San Francisco

Document type: Study Protocol 
 
Study title: Development and Pilot Test of an mHealth Interactive Education and Social Support 
Intervention for Improving Postnatal Health – Phase 1  
 
NCT number: NCT04636398 
 
Document date:  June 1, 2020 
 

 
Specific Aims: We propose developing a mobile interactive education and support group intervention, Maa 
Shishu Swasthya Sahayak Samooh (MeSSSSage), to improve the health and well-being of Indian women and 
infants in the postnatal period using a provider-moderated group approach. MeSSSSage will provide culturally 
tailored educational programming, increase women’s health-related communication with providers, refer women 
in a timely and appropriate manner, and connect them with a virtual social support group of other new mothers. 
MeSSSSage aims to reduce postnatal care barriers arising from distance, economic burden, cultural practices, 
and fatigue, and provide social support in this time to help reduce women’s postpartum isolation.  
Postnatal health care includes education and clinical care necessary for ensuring maternal and infant health: 
neonatal care practices (breastfeeding, newborn hygiene, etc.), prevention activities (immunization, recognition 
of infant danger signs, etc.), assessment of maternal physical recovery from childbirth, postpartum mental health, 
and postnatal contraception adoption. Postnatal care improves maternal physical and mental health, and well-
being.1–3 In Haryana state, India, only 40% of women received at least one postnatal health check in the two 
months after delivery.4 Extending group-based pregnancy care or women’s group models that have proven 
successful in improving maternal and neonatal outcomes in South Asia and elsewhere to the postnatal period 
could show health improvements.2 However, barriers exist to successfully implement postpartum group care, 
including logistical challenges of traveling to the facility or group meeting with a young baby and limited mobility 
in South Asia, including postnatal seclusion.6 Applying an mHealth approach to postnatal care may help new 
mothers overcome such challenges, and high mobile phone penetration in Haryana state, India, supports the 
feasibility of testing a group mHealth intervention in this population. 
 Most mHealth interventions for maternal and child health (MCH) in low and middle-income countries, 
including India, have focused on unidirectional and non-interactive approaches, primarily text messaging.5 
However, ample evidence suggests that provider-led, interactive educational programming and social support 
are key for improving health behaviors and outcomes.7,8 Thus innovative mHealth approaches that promote 
interactive education and facilitate social support have great potential to improve MCH outcomes. The two-phase 
development of MeSSSSage will include Phase 1: exploratory development on functions and platforms and 
Phase 2: a mixed-methods randomized pilot study using a factorial design of specific intervention functions and 
platforms confirmed in Phase 1. The specific aims of this study are: 
 
Aim 1. To develop optimal intervention functions, processes, and mHealth platforms for education and 
peer support among postnatal women in rural India. In Phase 1, we will explore potential interactive 
education and peer support group intervention functions (education, emotional support, instrumental support, 
referrals, linkages, follow-up on postnatal visits), processes (group interactions; frequency, length and timing of 
groups; engagement opportunities, participant profiles) and mHealth delivery platforms (voice, text chat, app 
options, interaction features). This two-month developmental component will include four groups (n=48; 12 per 
group) to assess different modalities and functions. We will ascertain women’s preferences for functions, 
processes, and platform features using survey and in-depth interviews (IDIs), and capture levels of engagement 
via back-end data. This process will also inform the intervention’s health information content. Findings will be 
used to formalize the group mobile intervention details to be examined in Phase 2. 
 
Aim 2. To assess the feasibility and acceptability of the optimized MeSSSSage intervention. In Phase 2 
we will evaluate the feasibility and acceptability of two intervention components using a controlled 4-arm factorial 
design (n=160; 40 per arm): 1) real-time mobile voice information and support group alone, 2) asynchronous/ 
on-demand text-based group support only, and 3) real-time mobile voice information and support group plus 
asynchronous/on-demand text-based group support. Feasibility and acceptability will be assessed via back-end 
data, surveys, and IDIs with purposively selected participants (n=30) and moderators. 
 
Aim 3. To explore the preliminary effectiveness of the optimized MeSSSSage intervention components 
on six-month maternal and neonatal health outcomes. Phase 2 data will help us develop a preliminary 
understanding of the impacts of the intervention components on MCH health-related knowledge, behaviors and 
outcomes including exclusive breastfeeding, immunization, family planning uptake, postnatal visits, mental 
health and empowerment; however, it is not statistically powered to formally assess effectiveness. 
 
This study is significant and innovative in addressing key priorities of NICHD’s Pregnancy and Perinatology 
Branch and using systematic, user-centered and experience-driven design approach. These results will inform 
the most acceptable, feasible, and potentially efficacious intervention design to be robustly tested through an 
R01 mechanism to assess effectiveness for maternal and infant health outcomes, explore other research 
questions relevant to intervention development and scale-up for postnatal health among South Asian women, 
and explore generalizability across populations.  
 

 
Significance 
 
Postnatal care and support improve both infant and maternal health and save lives. However, the majority 
of interventions are focused on antenatal care, skilled delivery, and family planning; substantially less attention 
has been paid to the postnatal period. The government of India’s Reproductive and Health Program recommends 
three postnatal visits; however, these are infrequently achieved.4,9 Recent Indian studies found postnatal 
checkups to be associated with reduced neonatal mortality.2 Furthermore, postnatal care and support can help 
improve practices essential for newborn health, including exclusive breastfeeding and immunization, which were 
at 50.3% and 62.2%, respectively, in Haryana state, the site of this study, according to the most recent Indian 
Demographic and Health Survey.4 Postnatal care, in addition to antenatal care and facility delivery, is associated 
with women’s uptake of family planning in India.10 Haryana state is designated as a high focus state for family 
planning by the Indian Ministry of Health and Family Welfare,11 and unmet need for family planning is high; one 
study reported that 64% of Indian women had an unmet need for family planning in the early postnatal period.12  
 
Women’s groups and group-based care models are promising for improving perinatal health. Group-
participatory learning and action models have significantly improved a variety of maternal and neonatal health 
indicators13,14 and group-based care provision models such as Centering Pregnancy,15 group-based prenatal 
care, and others have found increased rates of exclusive breastfeeding, increased postnatal contraceptive 
uptake, reduced postnatal depression, and increased immunization.16–19 Health improvement through women’s 
groups and group-based care models capitalize on improved efficiency of education and information delivery 
associated with the group setting and through strengthening social support networks.20 Furthermore, the group 
delivery model is acceptable to women. Social support is positively associated with postnatal health,21,22 
particularly for the prevention of postnatal depression and anxiety23,24 and for breastfeeding maintenance.25,26 
Group care has been associated with women’s empowerment.27 Extending group care into the postnatal period 
is an innovating and promising approach for improving health outcomes for the mother and neonate.  
 
Significant logistical barriers prevent mothers from physically attending postnatal social support groups 
at facilities or other locations that may be far from their homes, particularly in India.28 mHealth 
approaches offer an innovative opportunity to overcome these barriers. Common logistical challenges of 
transportation and scheduling are exacerbated in India by rural geographic distances, cultural and linguistic 
barriers to care, women’s practice of postnatal seclusion and generally low levels of mobility in marriage; all 
combine to significantly reduce care access.29–31 Further intergenerational and gender-based hierarchical roles 
structure decision-making in Indian households, particularly for couples living in extended-family households, 
with decision-making largely outside of the hands of mothers32, especially those who are young and newly 
married. Despite women’s physical mobility limitations in this setting, there is broad access to cellular telephones 
in India with 88% of households nationally owning a mobile phone.33 In our target region Haryana state, 51% of 
women own their own feature mobile phone.34 Mobile learning platforms have been successfully used for training 
among other populations such as community health workers in constrained environments by members of our 
research team.35 Testing the acceptability, feasibility, and effectiveness of a group care mHealth model is exciting 
and practical given increasing access to mobile technology globally, and such a model overcomes the physical 
and cultural barriers inherent to in-person group models.    
 
Providing targeted education and support to women in the postnatal period through a mobile social 
network holds potential to improve postnatal recovery, neonatal care practices, nutritional status, 
general health, knowledge and care seeking - positively impacting maternal and child health. Mobile 
support and education groups are based on prominent health behavior change theories such as the capabilities 
and motivation constructs of the COM-B framework,18,19 and have positively impacted a variety of other health 
outcomes in both developed and developing world settings.2,10 Targeted interactive education and support to 
women in the postnatal period through a mobile social network is hypothesized to meet their knowledge needs, 
improve self-efficacy and maternal mental health, and alter perceived social norms. All of these are important for 
appropriately identifying infant and maternal danger signs and timely care seeking for routine and emergency 
visits (including referrals), and reduce infant and maternal mortality and morbidity (Figure 1). Furthermore, 
mHealth group support could help encourage and sustain exclusive breastfeeding, and improve uptake of 
postnatal family planning and childhood vaccination, which positively impact maternal and child health in both 
short and long term. The social support component will encourage free discussion, allowing women to share 
experiences and tips for success (advice on soothing a crying baby, balancing family obligations with caring for 
her own healing body, etc.), providing informational social support. Interventions targeting informational and 

 
emotional social support have previously resulted in improved maternal and neonatal health, including reduced 
postnatal depression36,37.  
 
Figure 1. Conceptual Framework of MeSSSSage Intervention Targets and Outcomes 
 
 
 
Innovation. This proposal extends the current evidence in two primary ways: 
1. This study seeks to develop an mHealth group care intervention, combining the potential for mHealth to reach 
vulnerable populations in lower resource settings with the key health benefits of multidirectional, social 
interactions with both social support and health care providers. Most mHealth interventions are unidirectional, 
do not involve social support, or are targeted towards health providers, rather than clients themselves.  
2. We extend the solid evidence base for group care in pregnancy to the postnatal period, a neglected and vital 
period for infant heath outcomes, as well as maternal mental and physical health outcomes. Postnatal care is 
especially challenging in settings like rural India where women live far from facilities, have restrictions on 
physical mobility, and practice seclusion after childbirth.  
 
The approach taken in this research will add to the scientific understanding of whether mHealth interventions 
can successfully include group components and interaction between users. It will also expand our toolkit of 
approaches for intervening in the postnatal period, with applications for other times in the life course and 
populations. If proven successful, this study will lead to the development of a tested tool ready for next steps in 
scale up process to robustly test effectiveness that is likely to improve both maternal and infant health outcomes.  
 
Approach 
The mobile platform we will be adapting was developed by members of our IIIT-Delhi team, and has been tested 
with the implementing partner (SWACH). This innovative platform provides a single collaborative learning 
environment that is optimized for use by both basic feature phones and smartphones. This simultaneously lowers 
the cost and increases the reachability while accommodating increasing technology access. The back-end of 
the systems is built on Interactive Voice Recognition (IVR) technology that allows easy data collection that can 
then be used for analysis on user participation. Moreover, the system allows the storage of the knowledge 
generated in an interactive session. Recently the system has been extended by applying state-of-the-art natural 
language processing techniques to extract the audio and create a knowledge base which can then be used to 
deliver automated answers.38 It has previously been tested for feasibility with SWACH in the general population, 
and as a training for health workers and found improvements in health worker knowledge.35,39 Members of the 
team have also developed a platform similar to WhatsApp that may be integrated into this design or added on to 
support the MeSSSSage design.  
 
Study Site and Population: This study will occur in Kurukshetra district, Haryana state, India. Household mobile 
phone ownership is high, with 90% of households, and 50% of women, in this district owning a mobile phone.4 

 
The current national guidelines for postnatal care in India are for women to receive three home visits from an 
ASHA within the first week following childbirth.4,9 In this setting, women are seen by an Accredited Social Health 
Activists (ASHA) in pregnancy and postpartum. The role of the ASHA in postnatal care is to counsel the mother 
on recognition of and referral for complications. The ASHA also counsels the mother on adoption of postpartum 
family planning. For newborns, the ASHA provides skin, eye and cord care, monitors infant weight gain, supports 
exclusive breastfeeding, and provides general newborn care and referral. However, data from our study state, 
Haryana, suggest that less than half of women receive any postnatal care,4 and ASHA visits are typically 
short, all of which restricts the information and support that women receive in the postnatal period.    
 
Phase 1: Aim 1. To develop optimal intervention functions and mHealth technology delivery platforms 
for education and peer support among postnatal women in rural India: The prototype MeSSSSage will 
include a weekly mobile call-in group meeting, including recently delivered women and moderated by one trained 
health worker, an experienced ASHA facilitator. Each group will consist of 12 women whose infants were born 
within approximately two weeks of each other. Women will attend these group meetings by calling in on their 
mobile phone, and the meetings will last approximately one hour. In each group, the ASHA facilitator will provide 
approximately 20 minutes of health education specifically tailored to the common health needs of the mother 
and infant at the specific infant age, followed by 40 minutes for group discussion. Aim 1 will inform exact length 
of education and discussion per meeting), and if and at what frequency reminder messages are required. 
Development of optimal modalities: We will pilot the prototype MeSSSSage platform in three groups of recently 
delivered women for a period of two months by testing different modalities over that time, as described in Table 
1 (N=48). The goal of this formative phase is to orient women to a variety of experiences to reflect on when 
seeking their feedback, so as to design the most appropriate intervention for full piloting.   
 
Table 1: Modalities to be explored to identify optimal intervention functions, processes and platforms (Phase 1). 
  
Modality  
Description of modalities 
Goal 
Group structure 
(1) Frequency: How often groups are held 
(2) Length: How long groups last 
(3) Timing: What time of day/day of week 
To determine the best group structure 
Participants 
(1) Number  
(2) Breadth of gestational age 
(3) Age of respondents 
To determine the best group structure 
Group 
Interaction type 
(1) Women have to “raise their hand” virtually, by typing a 
specified number into their phones if they have a 
question or comment, and then the moderator gives 
“permission” to women to speak one by one  
(2) Open line where women can speak at any point.  
(3) Moderator call out individual women to ask if they 
have questions or comments 
To measure:  
● Level of comfort with participation 
● Amount of engagement and 
interactions between participants 
● Conversation dominated by certain 
participants 
● Communication patterns  
Content 
(1) Additional information desired 
(2) Level of detail of information 
(3) Language and approach used by moderators 
To adjust and expand the content/topics 
covered  
Text-based 
group addition  
Offer an additional freer-form, ongoing, text-based group 
(e.g., WhatsApp) 
To determine:  
● Number of interactions 
● Barriers for women with low literacy 
● Group sense of support 
Procedures: Primiparous women will be recruited in their last month of pregnancy by the ASHA and an 
accompanying research assistant during the ASHA’s regular home visit. At the time of enrollment, the study 
protocol and informed consent will be described to the women, written informed consent will be obtained from 

 
interested women, and their phone numbers collected (and tested). Women who do not personally own a phone 
will be provided with a phone. Airtime for all participants will be covered during this two-month preliminary phase 
of the project. Consent will also be obtained from family members given the cultural practices in the study 
population. Consent will cover both the intervention and the evaluation components of our phase 1 assessment.  
Women are eligible if they are over the age of 18 and this is their first birth. Women with high risk pregnancies 
will be ineligible for participation, and women will be removed from the study if they deliver preterm, suffer severe 
maternal complications (c-section or hospitalization), or they or their baby are otherwise sick in the first week 
postnatal. When the women deliver their infants, the ASHA and facilitator will inform the research team, and 
women will be assigned to groups based on date of delivery, since women in each group ideally will have all 
delivered their babies within approximately two weeks of each other. 
 
Back-end data will be captured from all participants. After two months (eight group meetings) we will conduct 
a brief phone survey with all participants and in-depth interviews with a subset of approximately half of the 
participants, purposively selected to obtain a range of frequency and intensity of participation.  
 
Surveys and backend data: All 48 respondents will be called via phone to participate in a short (10 min) survey 
about their experiences with MeSSSSage group components, including preferences regarding functions and 
modalities and level of satisfaction with each, using likert-type response scales (1-5). Data will be recorded on a 
tablet confidentially. We will calculate means and standard deviations for each of the preferences and function 
variables. Additionally, each group discussion will be audio recorded, transcribed, and translated into English. 
We will analyze the content of the group discussions for function, using Atlas.ti software. We will also review 
level of intervention engagement including text-messaging (number and topic), the number of participants per 
session, number of participants who engage with the health worker and each other, etc. The study team has 
analyzed the data collected in previous technological studies, and we will use a similar method. Data will be 
analyzed using STATA version 15 (College Station, Tx).  
 
In-depth interviews (IDIs): We will recruit a subset of Phase 1 participants (n=30), equal numbers from each 
group, to participate in IDIs. The interviews will be used to explore women’s experiences participating in 
MeSSSSage, the components they liked and disliked, and how to improve the programming. Specifically, we will 
focus on the timing and frequency of the group meetings, as well as feedback on the modalities tested in the 
different arms.  We will explore their experience of the social support component of MeSSSSage and how this, 
or another, mobile technology might be used to increase the support available to them. In addition to gathering 
information their experience with MeSSSSage, we will also explore which health topics related to postnatal 
maternal and infant health are they most interested in, and their main health-related concerns. IDIs will also be 
conducted with the ASHA facilitators who will be delivering the educational content of the mobile voice groups 
and moderating the mobile text groups to understand their own preferences around the group components, their 
experiences conducting the sessions, and their perspectives on mobile provision of education, care, and support. 
IDIs will take place the respondent’s home, or another private location of their preference. IDIs will be transcribed 
and translated into English. IDI data will then be coded by a team of both India and US-based researchers using 
a grounded theory framework, in the qualitative data analysis software Atlas-ti.  
 
Phase 2: Pilot test of optimized intervention, assessment of feasibility and acceptability (Aim 2) and 
preliminary effectiveness on maternal and infant health outcomes (Aim 3). After analysis of Phase 1 data, 
MeSSSSage will be adapted based on participant feedback and content will be expanded to cover topics relevant 
to the first six months of the postnatal period. If data from Phase 1 suggest that the tested mobile group forum 
modalities are not appropriate for this population, we will adapt our study protocol to explore other feasible means 
of providing information and support (e.g., SMS or video). We anticipate developing and testing two different 
modalities of postnatal education and support in a factorial design with an additional control arm for a total of 
four different group compositions. All women, including the control group, will receive the standard of care 
provided by the Government of India and described above. We will conduct a pilot test of the intervention using 
two groups per intervention modality for a total of eight separate groups, a total of 160 women (Table 2). Exact 
group structure and duration will be informed by Aim 1, but we anticipate the following:  
 
 
 

 
Table 2: MeSSSSage components to be tested in feasibility and acceptability assessment (Phase 2). 
 
 
Arm 1 
Arm 2 
Arm 3 Control 
Real-time live voice call group meeting: Interactive educational program with 
scripted didactic component plus discussion/question.  Lead and moderated by 
health professional.   
X 
 
X 
 
Text-based, asynchronous, on-demand social support: App-based small group 
text-based communication. Moderated by health professional.  
 
X 
X 
 
Standard of care: 3 visits in the first 7 days postnatal (facility and home) 
X 
X 
X 
X 
 
Procedures: Unless found not feasible or acceptable within Phase 1 activities, women will be recruited using the 
approach described above (Aim 1). At the time of enrollment, the study protocol will be described to the women 
following informed consent procedures and written informed consent will be obtained from interested women, 
and their phone numbers will be collected (and tested). Women who do not have a phone will be provided with 
a phone and all participants’ airtime will be covered for the length of the six-month research project. If they 
consent to participate, women will be randomly enrolled into one of the three study arms, or control, using a 
random number generator. We will test each study condition using two groups of women, with intervention 
initiation staggered one month apart. Women in the control group will receive the standard of care for women in 
this population. All women will be given 50 Indian Rupees for participation in each session (in addition to airtime 
and phone if needed), and ASHAs will receive 150 Indian Rupees for moderating each session. Assessment of 
feasibility and acceptability (Aim 2) and preliminary effectiveness (Aim 3) will be accomplished using a mixed-
methods approach that will include quantitative surveys, in-depth interviews, and technology assessment. 
Survey data collection: At study enrollment, a baseline survey will be administered by a research assistant in 
the respondent’s home. Roughly six months postnatal, after having the opportunity to participate in approximately 
24 MeSSSSage sessions (final number to be determined in Phase 1 activities), women will be visited in their 
homes for the endline survey. We will also capture women’s health record cards and ASHA registers to validate 
self-reported health outcome data. Data will be collected on a tablet using REDCap mobile research 
administration software (a highly secure platform), stored in a password protected database at UCSF, and no 
identifiable information will be included with the data (names, phone numbers, and addressed will be stored 
separately and linked by an ID).  
In-depth interviews: Additionally, in-depth interviews (IDIs) will be conducted with a selection of 10 women 
from each intervention condition (30 IDIs), purposively sampled based on high/low participation rates determined 
by the end line survey. We will collect data on experiences with MeSSSSage and how to improve it. 
Technology assessment: Finally, we will collect and analyze the quantitative backend data from the prototype 
to gain more insight into women’s participation in the intervention, including attendance and level of participation 
in group interactive educational sessions, use of mobile social support platform (number of posts, frequency, 
topic), etc. Text data from transcripts of the educational sessions and content of group messaging will be 
analyzed for content in order to understand primary educational needs and interests for postnatal women.  
Group moderator survey and interview: ASHA facilitators moderating the groups will be asked to respond to 
a short questionnaire after each group session to understand: preparation and delivery time, content, efficiency, 
acceptability and satisfaction with the group model, perspectives of impact, challenges, and any follow-up/referral 
necessary.40 Regarding facilitation of groups that receive the text-based messaging intervention component only, 
ASHA facilitators will report on experiences in the prior week. We will also conduct monthly semi-structured 
interviews with each of the ASHA facilitators to understand their own preferences around the group components, 
their experiences preparing for and conducting the sessions, and their perspectives on mobile provision of 
education, care, and support. 
 
Measures: The baseline survey content will include sociodemographic characteristics and knowledge about 
maternal and infant health, self-efficacy, and perceived social norms regarding MCH-related health promoting 
behaviors. The endline survey will include acceptability questions such as women’s satisfaction with and 
perceptions of MeSSSSage, maternal and infant knowledge-, behavior-, and health-related questions including 
about breastfeeding, complementary food introduction, immunization, family planning uptake, maternal physical 
and mental health, etc. which have previously been used in this setting (Table 3) 4.  
 

 
Table 3: Participant survey measures (Phase 2)   
 
Category 
Measures 
Sociodemographic 
characteristics 
Age, age at marriage, educational attainment, caste, language spoken, household assets, 
women’s status/decision-making, social support and relationship quality.  
Health-related 
knowledge 
(effectiveness) 
Knowledge on maternal and neonatal danger signs, best practices for infant care, family 
planning. 
Health-related behaviors 
(effectiveness) 
Breastfeeding and complementary food introduction practices (breastfeeding initiation, 
length of exclusive breastfeeding, length of breastfeeding, timing of complementary food 
introduction), appropriate management of early childhood illnesses. 
Health outcomes 
(effectiveness) 
Early childhood immunization, postnatal depression and anxiety, postnatal family planning 
adoption.  
Intervention perspectives 
(feasibility, acceptability) 
Self-reported engagement in intervention components and topics, satisfaction with 
intervention components, likelihood of participating again, likelihood of recommending 
program, value on knowledge and social support gained from participation.  
 
 
Analysis 
Aim 2. Feasibility and acceptability of the optimized MeSSSSage intervention components. We will use a mixed 
methods approach, triangulating data from quantitative baseline and endline data, qualitative IDIs, and 
technology assessment. Feasibility and acceptability will be measured by participation rates at each session, 
trajectories of participation over time, and user engagement (via technology assessment backend data). 
Women’s reports of use and satisfaction in the survey and the qualitative data will shed light on barriers and 
facilitators to participation. Moderator acceptability will be assessed by satisfaction, fidelity to topic/content based 
on protocol and perspectives on impact. We will test for differences in feasibility and acceptability between the 
three intervention arms to understand if both components (group meetings and text) or only one is the best 
approach, using ANOVA for continuous outcomes and chi-square or Fisher’s exact tests, as appropriate, for 
categorical outcomes.   
  
Aim 3. Preliminary effectiveness of the MeSSSSage intervention components on six-month MCH outcomes. 
Using the quantitative survey data, we will statistically evaluate differences by study arm in improvements in 
women’s knowledge, behaviors, and maternal and child health outcomes, compared to the control group 
(including effect sizes, controlling for relevant socio-demographics as necessary). Figure 1 displays the 
outcomes that are theoretically related to our intervention targets. Our main knowledge outcome will be a 
composite score representing the proportion of correct answers from a series of questions on knowledge of 
breastfeeding, newborn and infant care, maternal and infant danger signs, newborn care, and family planning, 
topics that will be covered within our interactive educational group component. Our main behavior outcome will 
be self-reported exclusive breastfeeding at 6 months. Our two main health related outcomes will be: (1) 
completion of early childhood immunization schedule; and (2) postnatal family planning uptake. We will also 
measure women’s social support and related mental health status (depression and anxiety) using scales that 
have been previously validated in similar populations such as the Hopkins Symptom Checklist41 and the 
Multidimensional Scale of Perceived Social Support42. Finally, women’s empowerment will be measured using 
decision-making and mobility scales.43,44 
 
Sample Size. This pilot development study is not formally powered to detect significant differences in outcomes, 
but will give insight into directionality of changes. The per group sample size was selected based on feasibility 
of recruitment, intervention delivery, and the interpersonal interaction important for a group-focused intervention. 
The sample is sufficiently large to assess the feasibility and acceptability outcomes through descriptive statistics. 
 
 
 

 
Timeline. Phase 1, which includes the intervention optimization and development period, and Aim 1 data 
collection, will occur in quarter 2 (Q2) of Year 1 (Y1), after Q1 is spent preparing for the study (IRB, instruments, 
training research team). In Y1Q3 we will finalize the details of the mhealth platform and prepare for Phase 2 (tool 
development, IRB modifications, training research team). From Y1Q4-Y2-Q2 we will recruit and collect data for 
Phase 2, which is a 6 month pilot intervention. Y2Q2-Q3 will be spent in in-depth data analysis for Aims 2 and 
3. The final part of the grant (Y2Q3 and Q4) will be spent in dissemination (local and international) including 
meetings, presentations, academic manuscripts, and conferences. We will also apply for a larger grant to test 
this at scale. Please see our timeline table in the human subjects and clinical trials supplement.  
 
Capacity building. IIIT Delhi has a new Social Science Department; however, most faculty and students have 
little training in research methods such as mixed-methods and qualitative research. Drs. Diamond-Smith and El 
Ayadi are experienced in leading workshops on study design and analysis, particularly for these topics. They will 
teach a one-week workshop to IIIT Delhi faculty and students on designing and evaluating interventions, and 
mixed-methods approaches for evaluation, including qualitative data analysis. Furthermore, IIIT PhD students 
will participate in this workshop and assist in collecting the qualitative interviews in Phases 1 and 2, as well as 
analyzing the qualitative data. Drs. Diamond-Smith and El Ayadi will mentor students throughout, including 
preparing manuscripts with them for publication in a 3-day writing workshop at the end of the project. The 
research team proposed herein has recently been awarded a two year capacity development award through the 
Government of India, Ministry of Human Resource Development, Scheme for Promotion of Academic and 
Research Collaboration to provide training on mHealth design and evaluation for maternal and child health. 
 
Potential problems and alternate strategies 
Recruitment and retention. The research team has successfully conducted research among women in the 
postpartum period living in this area, and have been successful in recruitment and retention. We do not anticipate 
challenges to recruitment of study participants or retention during the full study period. If women appear to be 
lost to participation, the local ASHA will be notified and she will follow up with the woman participant to determine 
the barriers to her participation in the intervention.  
    
Gender gaps in mobile phone access. While mobile phone penetration is increasing dramatically across all of 
India, significant gender gaps exist in ownership and use of mobile technologies. For example, among the adult 
population, 84% of males are considered primary mobile phone owners compared to 65% of females.34 Younger 
individuals have higher mobile phone ownership than older individuals; our target population of primiparous 
women is likely to fit within an age group of higher mobile ownership. We will provide participants who do not 
personally own their own phone with a phone to reduce barriers to participation resulting from multiple household 
phone users, and will provide airtime for the study to all participants.  
 
Low literacy among target population. Recent data from Haryana state show that 75% of women of reproductive 
age are literate4, and thus it is possible that women’s low overall literacy, and potentially low technological 
literacy, will reduce their ability to engage in MeSSSSage. However, the research team’s experience has not 
found this to be a problem for prior research projects among the target population. Additionally, given the young 
age of participants, we anticipate that they will be more literate and tech-savvy than average. Our experience of 
our team in the field at this specific study site has found that WhatsApp is extensively being used for 
communication and husbands are more actively involved in pregnancy and can support their wives. The 
MeSSSSage platform will allow illiterate women to speak to answer questions, thus making it more accessible 
to low literacy women. At enrollment, the research assistants will provide one-on-one training participation in the 
group meeting and text-based components of the intervention, including basic instructions on texting. Given the 
population we seek to generalize our findings to, we will not exclude illiterate women from this study.  
 
Expected outcomes and future directions. Our pilot results will inform the design of a larger R01 trial to 
robustly test the effectiveness of MeSSSSage on postnatal maternal and infant health behaviors and outcomes. 
We expect to positively impact women’s postnatal health knowledge and behaviors, and improve health 
outcomes for women and their infants in the first six months. We will also disseminate the findings to health 
professionals and community members, as well as appropriate Indian stakeholders (Government, NGO, etc.). 
Our study will help build the evidence on mHealth for maternal and perinatal health, and group care models for 
postnatal care, contributing to reducing disparities in women’s access to care through the removal of geographic 
and social barriers.  
 

 
References 
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