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Completed

NCT Number: NCT04693585

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MESSSSAGE - live

Behavioral

mHealth education and social support intervention, synchronous via call

MESSSSAGE - asynchronous

Behavioral

mHealth education and social support intervention, asynchronous via text

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. Number of Participants With Knowledge on Maternal and Neonatal Danger Signs, Best Practices for Infant Care, Family Planning.

    Time frame: 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.

  2. Number of Participants Exclusively Breastfeeding

    Time frame: 6 months

    Number of participants who exclusively breastfed their infants through 6 months of age

  3. Number of Participants Reporting Postpartum Depression

    Time frame: 6 months

    Number of participants reporting postpartum depression symptoms at six months

  4. Number of Participants Who Adopted Postpartum Family Planning

    Time frame: 6 months

    Number of participants who started a modern contraceptive methods within 6 months postpartum

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Indraprastha Institute of Information Technology Delhi
  • Post Graduate Institute of Medical Education and Research, Chandigarh
  • Survival for Women and Children Foundation
  • University of California, Los Angeles

Registry information

Official study title

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

Acronym: MESSAGE

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 5, 2021
Registry last updated
Jun 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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