Development and Pilot Test of a Postnatal mHealth Intervention - Phase 2

Study Overview
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Brief Summary
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The goal of the study is to assess the feasibility and acceptability of the optimized MeSSSSage intervention which was developed and revised based on the results of our initial pilot testing. The investigators will conduct a controlled 4-arm factorial design randomized study to test the feasibility, acceptability and preliminary effectiveness of several intervention modalities over a 6-month period.

Detailed Description
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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. However, ample evidence suggests that provider-led, interactive educational programming and social support are key for improving health behaviors and outcomes. 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 include sPhase 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. Study activities described herein are associated with Phase 1. The study's specific aim is: To test the optimized intervention to understand the feasibility, acceptability and preliminary effectiveness of several intervention modalities among postnatal women in rural India. In Phase 2, the investigators conduct a randomized factorial design to understand the contribution to various intervention modalities on feasibility, accessibility and preliminary effectiveness. Data are collected via quantitative participant survey (baseline and endline) including sociodemographic characteristics and knowledge about maternal and infant health, self-efficacy, and perceived social norms regarding MCH-related health promoting behaviors (baseline) 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. The investigators will validate self-report with health records. The investigators will conduct in-depth interviews among a purposive sample of 30 women to understand: mobile technology familiarity prior to intervention, perspectives on intervention and challenges, structure of intervention (group, individual), content, perspectives on the text-based component, relationship with other participants, perspective on the moderator, postnatal period health related concerns, sources of support (social and informational), recommendations. Other assessment will include technological data from, and group moderator surveys and interviews.

Official Title
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Development and Pilot Test of an mHealth Interactive Education and Social Support Intervention for Improving Postnatal Health - Phase 2

Conditions
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Health Attitude, Knowledge, Attitudes, Practice, Post Partum Depression, Acceptability of Health Care

Intervention / Treatment
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* Behavioral: MESSSSAGE - live
* Behavioral: MESSSSAGE - asynchronous


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postnatal (within 2 weeks) 18+ years old Exclusion Criteria: Women below 18 years of age Women with high risk pregnancies Women who delivered preterm, suffer severe maternal complications or they or their baby are otherwise sick in the first week

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: The three intervention modalities to be tested include: real-time live voice calls versus audio/video recording; text-based, asynchronous, on-demand social support; and standard of postnatal care (3 visits in first 7 days).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: live support<br>Real-time live voice call plus standard of postnatal care. | Behavioral: MESSSSAGE - live<br>* mHealth education and social support intervention, synchronous via call<br>|
| Experimental: Arm 2: asynchronous support<br>Text-based, asynchronous, on-demand social support plus standard of postnatal care | Behavioral: MESSSSAGE - asynchronous<br>* mHealth education and social support intervention, asynchronous via text<br>|
| Experimental: Arm 3: both live and asynchronous support<br>Real-time live voice call plus standard of postnatal care; text-based, asynchronous, on-demand social support plus standard of postnatal care | Behavioral: MESSSSAGE - live<br>* mHealth education and social support intervention, synchronous via call<br>Behavioral: MESSSSAGE - asynchronous<br>* mHealth education and social support intervention, asynchronous via text<br>|
| No Intervention: Arm 4: control<br>Standard of postnatal care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfied or very satisfied about their overall intervention experience | Proportion of participants reporting to be satisfied or very satisfied with their overall intervention experience, assessed through a five-point Likert scale at six months. | 6 months | 
| Participation rate | Weekly engagement in intervention activities by 6 months | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge on maternal and neonatal danger signs, best practices for infant care, family planning. | Proportion of participants correctly identifying at least 80% of knowledge on maternal and neonatal danger signs, best practices for infant care, and family planning at 6 months. | 6 months | 
| Exclusive breastfeeding | Proportion of participants exclusively breastfeeding their infants through 6 months of age | 6 months | 
| Postpartum depression | Proportion of participants reporting postpartum depression symptoms at six weeks, three months and six months | 6 weeks, 3 months, 6 months | 
| Postpartum family planning adoption | Proportion of participants having started a modern contraceptive methods within 6 months postpartum | 6 months |