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Clinical Trials/NCT04693585
NCT04693585
Completed
Not Applicable

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

University of California, San Francisco1 site in 1 country201 target enrollmentJuly 30, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Health Attitude
Sponsor
University of California, San Francisco
Enrollment
201
Locations
1
Primary Endpoint
Number of Participants Engaging in Group Call Intervention
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 30, 2021
End Date
November 15, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Factorial
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Number of Participants Engaging in Group Call Intervention

Time Frame: 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

Time Frame: 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 Outcomes

  • Number of Participants With Knowledge on Maternal and Neonatal Danger Signs, Best Practices for Infant Care, Family Planning.(6 months)
  • Number of Participants Reporting Postpartum Depression(6 months)
  • Number of Participants Exclusively Breastfeeding(6 months)
  • Number of Participants Who Adopted Postpartum Family Planning(6 months)

Study Sites (1)

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