Development and Pilot Test of a Postnatal mHealth Intervention - Phase 2
Condition: Health Attitude; Knowledge, Attitudes, Practice; Post Partum Depression; Acceptability of Health Care
MeSH terms: Depression, Postpartum
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): MESSSSAGE - live; MESSSSAGE - asynchronous
Intervention type(s): Behavioral; Behavioral
Intervention description(s): mHealth education and social support intervention, synchronous via call; mHealth education and social support intervention, asynchronous via text
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention 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)
Primary purpose: Prevention