mHealth India Postnatal Health Intervention Effectiveness
Kushal Maa
Effectiveness of an mHealth Interactive Education and Social Support Intervention for Improving Postnatal Health
2 other identifiers
interventional
2,100
1 country
3
Brief Summary
The goal of this study is to assess the effectiveness of a culturally-tailored mobile interactive education and support group intervention to supplement standard postpartum care activities in comparison to standard care alone on health-related behaviors and health outcomes in a randomized controlled trial among 2100 postpartum Indian women living in 3 geographically diverse Indian states to estimate the impact on maternal and neonatal health-related knowledge, health-related behaviors, and health outcomes. The investigators also seek to characterize mechanisms of impact including knowledge, social support, self-efficacy, and behavior change, and determine the cost-effectiveness.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2025
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2022
CompletedFirst Posted
Study publicly available on registry
March 7, 2022
CompletedStudy Start
First participant enrolled
January 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2027
April 1, 2026
March 1, 2026
2.4 years
February 24, 2022
March 31, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Exclusive breastfeeding
Proportion of participants reporting exclusive breastfeeding at 3 and 6 months
6 months
Postpartum depression
Proportion of participants reporting postpartum depression symptoms at 3 and 6 months
6 months
Postpartum family planning adoption
Proportion of participants not wanting to become pregnant immediately having started a modern contraceptive method within 6 months postpartum
6 months
Secondary Outcomes (4)
Maternal and neonatal danger sign knowledge
6 months
Maternal and neonatal health care use
6 months
Neonatal preventive health care use
6 months
Infant vaccination
6 months
Study Arms (2)
Intervention Arm
EXPERIMENTALThe mHealth education and social support intervention includes tailored weekly educational content via interactive voice recognition and an android application, a phone-based provider-moderated group discussion, a provider-moderated group text chat, and referral to care as needed. Individuals are enrolled into groups of 20, have two intervention sessions prenatally and then have weekly meetings through six months postpartum for a total of 26 sessions.
Control Arm
NO INTERVENTIONStandard postnatal care.
Interventions
group mHealth education and social support intervention
Eligibility Criteria
You may qualify if:
- Pregnant (28-32 weeks gestational age)
- Speak local language
- Personal mobile phone or willing to accept study phone
- Able to provide informed consent
You may not qualify if:
- Do not speak local language
- No personal phone or unwilling to accept study phone
- Unable to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sangathcollaborator
- University of California, San Franciscolead
- Post Graduate Institute of Medical Education and Research, Chandigarhcollaborator
- Indraprastha Institute of Information Technology Delhicollaborator
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)collaborator
Study Sites (3)
Post-Graduate Institute for Medical Education and Research
Chandīgarh, Haryana, India
Sangath
Bhopal, Madhya Pradesh, India
Indraprastha Institute for Information Technology
New Delhi, National Capital Territory of Delhi, India
Related Publications (1)
El Ayadi AM, Duggal M, Gopalakrishnan L, Bagga R, Singh P, Lin T, Bhan A, Saunik S, Verma GS, Ahuja A, Kaur J, Tugnawat D, Gujarathi S, Singh A, Khan A, Chandke D, Dhir SK, Dhakne-Palwe S, Kumar P, Patil M, Kumar S, Vasaikar N, Weil L, Diamond-Smith N. Effectiveness of Kushal Maa, a group-based mhealth interactive education and social support intervention for maternal and neonatal health outcomes: study protocol for a multisite randomised controlled trial in India. BMJ Open. 2025 Jun 27;15(6):e104213. doi: 10.1136/bmjopen-2025-104213.
PMID: 40578858DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alison M El Ayadi, ScD
University of California, San Francisco
- PRINCIPAL INVESTIGATOR
Nadia G Diamond-Smith, PhD
University of California, San Francisco
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2022
First Posted
March 7, 2022
Study Start
January 20, 2025
Primary Completion (Estimated)
May 31, 2027
Study Completion (Estimated)
May 31, 2027
Last Updated
April 1, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- On study completion
- Access Criteria
- Request of study team.
After study completion, de-identified data will be made available to other researchers upon reasonable request and completion of a data sharing agreement.