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

NCT ID: NCT04693585

Last Updated: 2024-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 201 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-30
• Study Completion Date: 2022-11-15

Brief Summary

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.

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 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.

Conditions

Health Attitude; Knowledge, Attitudes, Practice; Post Partum Depression; Acceptability of Health Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Arm 1: live support

Real-time live voice call plus standard of postnatal care.

Group Type: EXPERIMENTAL

MESSSSAGE - live

Intervention Type: BEHAVIORAL

mHealth education and social support intervention, synchronous via call

Arm 2: asynchronous support

Text-based, asynchronous, on-demand social support plus standard of postnatal care

Group Type: EXPERIMENTAL

MESSSSAGE - asynchronous

Intervention Type: BEHAVIORAL

mHealth education and social support intervention, asynchronous via text

Arm 3: both live and asynchronous support

Real-time live voice call plus standard of postnatal care; text-based, asynchronous, on-demand social support plus standard of postnatal care

Group Type: EXPERIMENTAL

MESSSSAGE - live

Intervention Type: BEHAVIORAL

mHealth education and social support intervention, synchronous via call

MESSSSAGE - asynchronous

Intervention Type: BEHAVIORAL

mHealth education and social support intervention, asynchronous via text

Arm 4: control

Standard of postnatal care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

MESSSSAGE - live

mHealth education and social support intervention, synchronous via call

Intervention Type: BEHAVIORAL

MESSSSAGE - asynchronous

mHealth education and social support intervention, asynchronous via text

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 M 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

Chandigarh, , India

Countries

India

References

Cox V, Sharma P, Verma GS, Gill N, Diamond-Smith NG, Duggal M, Kumar V, Bagga R, Kaur J, Singh P, El Ayadi AM. User acceptability and perceived impact of a mobile interactive education and support group intervention to improve postnatal health care in northern India: a qualitative study. BMC Med Inform Decis Mak. 2025 Feb 20;25(1):93. doi: 10.1186/s12911-025-02935-7.

Reference Type: DERIVED

PMID: 39980038 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

R21HD101786

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R21HD101786-A

Identifier Type: -

Identifier Source: org_study_id