Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04693585 |
| Other study ID # |
R21HD101786-A |
| Secondary ID |
R21HD101786 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 30, 2021 |
| Est. completion date |
November 15, 2022 |
Study information
| Verified date |
August 2023 |
| Source |
University of California, San Francisco |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
