Postnatal mHealth Intervention Development

Postpartum Depression Clinical Trial

— MESSAGE  

Official title:

Development and Pilot Test of an mHealth Interactive Education and Social Support Intervention for Improving Postnatal Health - Phase 1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04636398
• Other study ID #: R21HD101786
• Secondary ID: R21HD101786
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: January 30, 2021

Study information

• Verified date: May 2024
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: January 30, 2021
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Acceptability of Health Care
• Depression, Postpartum
• Health Attitude
• Knowledge, Attitudes, Practice
• Postpartum Depression

Intervention

Behavioral:
• MESSAGE - mHealth intervention
A group-based moderated six-week intervention with didactic, discussion, and text communication components.

Locations

Country	Name	City	State
India	Post Graduate Institute for Medical Education and Research (PGIMER)	Chandigarh

Sponsors (6)

Lead Sponsor	Collaborator
University of California, San Francisco	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

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Satisfied or Very Satisfied About Their Overall Intervention Experience	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.	6 weeks