Postnatal mHealth Intervention Development (MESSAGE)

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

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.

Study Overview

• Status: Completed
• Conditions: Health Attitude; Postpartum Depression; Knowledge, Attitudes, Practice; Acceptability of Health Care
• Intervention / Treatment: Behavioral: MESSAGE - mHealth intervention

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 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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Chandigarh, India
    • Post Graduate Institute for Medical Education and Research (PGIMER)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: MESSAGE mHealth group intervention; Participants in the one arm will be exposed to the mHealth group intervention. As this is a pilot developmental study, the participants will be exposed to various strategies for information delivery (live presentation at a scheduled time versus voice recording accessible at any time), discussion facilitation (heavily managed with request to speak vs. natural discussion participation), and text communication management (moderator-facilitated vs. group-led).

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); University of California, Los Angeles; Post Graduate Institute of Medical Education and Research, Chandigarh; Indraprastha Institute of Information Technology Delhi; Survival for Women and Children Foundation
• Investigators: Principal Investigator: Alison El Ayadi, ScD, University of California, San Francisco; Principal Investigator: Nadia G Diamond-Smith, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): January 30, 2021
• Study Completion (Actual): January 30, 2021

Study Registration Dates

• First Submitted: November 13, 2020
• First Submitted That Met QC Criteria: November 13, 2020
• First Posted (Actual): November 19, 2020

Study Record Updates

• Last Update Posted (Actual): June 4, 2024
• Last Update Submitted That Met QC Criteria: May 17, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Depressive Disorder; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depression, Postpartum
• Other Study ID Numbers: R21HD101786 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No