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Completed

NCT Number: NCT04636398

Postnatal mHealth Intervention Development

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.

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Key information

Conditions

Health Attitude Acceptability of Health Care Behavior Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Health Behavior Knowledge, Attitudes, Practice Mental Disorders Mood Disorders Patient Acceptance of Health Care Postpartum Depression Pregnancy Complications Puerperal Disorders Treatment Adherence and Compliance Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Post Graduate Institute for Medical Education and Research (PGIMER)

Chandigarh, India

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 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.

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

MESSAGE - mHealth intervention

Behavioral

A group-based moderated six-week intervention with didactic, discussion, and text communication components.

Primary outcomes

  1. Satisfied or Very Satisfied About Their Overall Intervention Experience

    Time frame: 6 weeks

    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.

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 1

Acronym: MESSAGE

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 19, 2020
Registry last updated
Jun 4, 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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