Postnatal mHealth Intervention Development

Study Overview
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Brief Summary
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This study is a six-week exploratory developmental phase (phase 1) of a larger project to develop an mHealth intervention targeting health education and social support for Indian women in the postnatal period. Phase 1 of the trial exposes study participants to various intervention modalities and seeks to understand their experiences and perspectives on these using mixed-methods. Results from this trial will inform modifications to the intervention to be tested in Phase 2.

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 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. Study activities described herein are associated with Phase 1. The study's specific aim is: To develop optimal intervention functions, processes, and mHealth platforms for education and peer support among postnatal women in rural India. In Phase 1, the investigators 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 six-week developmental component will include up to four groups (n=48; 12 per group) to assess different modalities and functions. The investigators 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.

Official Title
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Development and Pilot Test of an mHealth Interactive Education and Social Support Intervention for Improving Postnatal Health - Phase 1

Conditions
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Health Attitude, Knowledge, Attitudes, Practice, Postpartum Depression, Acceptability of Health Care

Intervention / Treatment
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* Behavioral: MESSAGE - mHealth intervention


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
Intervention Model: Single Group Assignment
Interventional Model Description: Non-randomized quasi-experimental exploratory study. All small groups will receive the same intervention which is exposure to a variety of intervention modalities (3 main modalities: information delivery, facilitation strategy, text management).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MESSAGE mHealth group intervention<br>Participants in the one arm will be exposed to the mHealth group intervention. As this is a pilot developmental study, the participants will be exposed to various strategies for information delivery (live presentation at a scheduled time versus voice recording accessible at any time), discussion facilitation (heavily managed with request to speak vs. natural discussion participation), and text communication management (moderator-facilitated vs. group-led). | Behavioral: MESSAGE - mHealth intervention<br>* A group-based moderated six-week intervention with didactic, discussion, and text communication components.<br>|

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 weeks. | 6 weeks |