NCT04693585: MESSAGE

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

Completed NA Results posted Last updated 12 June 2024

What this trial tests

NA trial testing MESSSSAGE - live in Health Attitude in 201 participants. Completed in 15 November 2022.

Timeline

30 July 2021

Primary endpoint
15 November 2022

15 November 2022

Quick facts

Lead sponsor	University of California, San Francisco
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	none
Primary purpose	prevention
Enrollment	201
Start date	30 July 2021
Primary completion	15 November 2022
Estimated completion	15 November 2022
Sites	1 location across India

Drugs / interventions tested

• MESSSSAGE - live
• MESSSSAGE - asynchronous

Conditions studied

• Health Attitude — all drugs for Health Attitude →
• Knowledge, Attitudes, Practice — all drugs for Knowledge, Attitudes, Practice →
• Post Partum Depression — all drugs for Post Partum Depression →
• Acceptability of Health Care — all drugs for Acceptability of Health Care →

Sponsor

University of California, San Francisco

Who can join

Adults 18 to 50, female only, with Health Attitude or Knowledge, Attitudes, Practice. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Reporting Being Satisfied or Very Satisfied About Their Overall Intervention Experience Primary · 6 months

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

Group	Value	95% CI
Arm 1: Synchronous and Asynchronous Support	90
Arm 2: Asynchronous Support	19

Number of Participants Engaging in Group Call Intervention Primary · 6 months

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

Group	Value	95% CI
Arm 1: Synchronous and Asynchronous Support	37

Number of Participants With Knowledge on Maternal and Neonatal Danger Signs, Best Practices for Infant Care, Family Planning. Secondary · 6 months

Number of participants correctly identifying at least 80% of knowledge on maternal and neonatal danger signs, best practices for infant care, and family planning at 6 months.

Group	Value	95% CI
Arm 1: Synchronous and Asynchronous Support	0
Arm 2: Asynchronous Support	0
Arm 3: Control	0

Number of Participants Exclusively Breastfeeding Secondary · 6 months

Number of participants who exclusively breastfed their infants through 6 months of age

Group	Value	95% CI
Arm 1: Synchronous and Asynchronous Support	79
Arm 2: Asynchronous Support	18
Arm 3: Control	11

Number of Participants Reporting Postpartum Depression Secondary · 6 months

Number of participants reporting postpartum depression symptoms at six months

Group	Value	95% CI
Arm 1: Synchronous and Asynchronous Support	43
Arm 2: Asynchronous Support	10
Arm 3: Control	5

Number of Participants Who Adopted Postpartum Family Planning Secondary · 6 months

Number of participants who started a modern contraceptive methods within 6 months postpartum

Group	Value	95% CI
Arm 1: Synchronous and Asynchronous Support	67
Arm 2: Asynchronous Support	14
Arm 3: Control	10

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Primary-level and community worker interventions for the prevention of mental disorders and the promotion of well-being in low- and middle-income countries.
   Purgato M, Prina E, Ceccarelli C, Cadorin C, et al · · 2023 · cited 17× · PMID 37873968 · DOI 10.1002/14651858.cd014722.pub2
2. 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.
   Cox V, Sharma P, Verma GS, Gill N, et al · · 2025 · PMID 39980038 · DOI 10.1186/s12911-025-02935-7
3. 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
   Cox V, Sharma P, Verma GS, Gill N, et al · · 2023 · DOI 10.21203/rs.3.rs-3320095/v1
4. Maternal health education and social support needs across the perinatal continuum of care in India: A thematic analysis
   Sharma P, Bagga R, Khan M, Duggal M, et al · · 2023 · DOI 10.21203/rs.3.rs-2721467/v1