Postnatal mHealth Intervention Development

NCT ID: NCT04636398

Last Updated: 2024-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2021-01-30

Brief 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.

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

MESSAGE - mHealth intervention

Intervention Type: BEHAVIORAL

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

Interventions

MESSAGE - mHealth intervention

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: collaborator

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role: collaborator

Indraprastha Institute of Information Technology Delhi

OTHER

Sponsor Role: collaborator

Survival for Women and Children Foundation

OTHER

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alison El Ayadi, ScD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Nadia G Diamond-Smith, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Post Graduate Institute for Medical Education and Research (PGIMER)

Chandigarh, , India

Countries

India

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R21HD101786

Identifier Type: NIH

Identifier Source: secondary_id

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R21HD101786

Identifier Type: NIH

Identifier Source: org_study_id

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