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

Not Applicable

Completed

• Conditions: Health Attitude; Post Partum Depression; Acceptability of Health Care; Knowledge, Attitudes, Practice
• Interventions: Behavioral: MESSSSAGE - asynchronous; Behavioral: MESSSSAGE - live

• Registration Number: NCT04693585
• Lead Sponsor: University of California, San Francisco

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-12-30
• Study First Submitted QC: 2020-12-30
• Study First Posted: 2021-01-05
• Study Start: 2021-07-30
• Primary Completion: 2022-11-15
• Study Completion: 2022-11-15
• Results First Submitted: 2023-11-15
• Status Verified: 2024-05
• Results First Submitted QC: 2024-05-17
• Last Update Submitted: 2024-05-17
• Results First Posted: 2024-06-12
• Last Update Posted: 2024-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 201

Inclusion Criteria

• Postnatal (within 2 weeks)
• 18+ years old

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Arm 2: asynchronous support	MESSSSAGE - asynchronous	Text-based, asynchronous, on-demand social support plus standard of postnatal care
Arm 1: live support	MESSSSAGE - live	Real-time live voice call plus standard of postnatal care.
Arm 3: both live and asynchronous support	MESSSSAGE - live	Real-time live voice call plus standard of postnatal care; text-based, asynchronous, on-demand social support plus standard of postnatal care
Arm 3: both live and asynchronous support	MESSSSAGE - asynchronous	Real-time live voice call plus standard of postnatal care; text-based, asynchronous, on-demand social support plus standard of postnatal care

Primary Outcome Measures

Name	Time	Method
Number of Participants Engaging in Group Call Intervention	6 months	Number of participants who engaged in weekly group call intervention activities by 6 months
Number of Participants Reporting Being Satisfied or Very Satisfied About Their Overall Intervention Experience	6 months	Number of participants reporting being "satisfied" or "very satisfied" with their overall intervention experience, assessed through a five-point Likert scale at six months.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Knowledge on Maternal and Neonatal Danger Signs, Best Practices for Infant Care, Family Planning.	6 months	Number 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.
Number of Participants Reporting Postpartum Depression	6 months	Number of participants reporting postpartum depression symptoms at six months
Number of Participants Exclusively Breastfeeding	6 months	Number of participants who exclusively breastfed their infants through 6 months of age
Number of Participants Who Adopted Postpartum Family Planning	6 months	Number of participants who started a modern contraceptive methods within 6 months postpartum

Trial Locations

Locations (1)

Post Graduate Institute for Medical Education and Research; 🇮🇳 Chandigarh, India