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

NCT04693585 | Completed Results

• 2 other identifiers: R21HD101786-AR21HD101786
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Number of Participants Reporting Being Satisfied or Very Satisfied About Their Overall Intervention Experience

  Number of participants reporting being "satisfied" or "very satisfied" with their overall intervention experience, assessed through a five-point Likert scale at six months.

  6 months

• Number of Participants Engaging in Group Call Intervention

  Number of participants who engaged in weekly group call intervention activities by 6 months

  6 months

Secondary Outcomes (4)

• Number of Participants With Knowledge on Maternal and Neonatal Danger Signs, Best Practices for Infant Care, Family Planning.

  6 months

• Number of Participants Exclusively Breastfeeding

  6 months

• Number of Participants Reporting Postpartum Depression

  6 months

• Number of Participants Who Adopted Postpartum Family Planning

  6 months

Study Arms (4)

Arm 1: live support

EXPERIMENTAL

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

Behavioral: MESSSSAGE - live

Arm 2: asynchronous support

EXPERIMENTAL

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

Behavioral: MESSSSAGE - asynchronous

Arm 3: both live and asynchronous support

EXPERIMENTAL

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

Behavioral: MESSSSAGE - live; Behavioral: MESSSSAGE - asynchronous

Arm 4: control

NO INTERVENTION

Standard of postnatal care.

Interventions

MESSSSAGE - live BEHAVIORAL

mHealth education and social support intervention, synchronous via call

Arm 1: live support; Arm 3: both live and asynchronous support

MESSSSAGE - asynchronous BEHAVIORAL

mHealth education and social support intervention, asynchronous via text

Arm 2: asynchronous support; Arm 3: both live and asynchronous support

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Postnatal (within 2 weeks)
• + years old

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• University of California, Los Angeles: collaborator
• Post Graduate Institute of Medical Education and Research, Chandigarh: collaborator
• Indraprastha Institute of Information Technology Delhi: collaborator
• Survival for Women and Children Foundation: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Post Graduate Institute for Medical Education and Research

Chandigarh, India

Location

Related Publications (1)

• 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.

  PMID: 39980038 DERIVED

MeSH Terms

Conditions

Behavior; Depression, Postpartum; Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Treatment Adherence and Compliance; Health Behavior

Results Point of Contact

• Title: Nadia Diamond-Smith
• Organization: University of California San Francisco

nadia.diamond-smith@ucsf.edu

415-353-4545

Study Officials

• Alison M El Ayadi, ScD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Nadia G Diamond-Smith, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The three intervention modalities to be tested include: real-time live voice calls versus audio/video recording; text-based, asynchronous, on-demand social support; and standard of postnatal care (3 visits in first 7 days).

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: January 5, 2021
• Study Start: July 30, 2021
• Primary Completion: November 15, 2022
• Study Completion: November 15, 2022
• Last Updated: June 12, 2024
• Results First Posted: June 12, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)