mHealth India Postnatal Health Intervention Effectiveness (Kushal Maa)

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ClinicalTrials.gov Identifier: NCT05268588

Recruitment Status : Not yet recruiting

First Posted : March 7, 2022

Last Update Posted : April 3, 2024

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Sponsor:

Collaborators:

Post Graduate Institute of Medical Education and Research, Chandigarh

Indraprastha Institute of Information Technology

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

Sangath

Information provided by (Responsible Party):

University of California, San Francisco

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Health Knowledge, Attitudes, Practice Post Partum Depression Breastfeeding Nutrition, Healthy	Behavioral: MESSSSAGE intervention	Not Applicable

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Detailed Description:

Maternal and infant mortality remain high in Northern India, at 167 per 100,000 live births and 49 per 1,000 live births, respectively. Access to perinatal care is increasing, yet gaps in care access and quality persist, particularly in peri-urban and rural areas. Steep drops in the perinatal continuum of care occur postpartum, with only 64% of mothers and 24% of infants receiving postpartum care, despite continuing maternal and infant risk. Ensuring continuity of high quality perinatal care into the postpartum period is key for maternal and infant health outcomes.

Postpartum care and support have received less focus than other perinatal continuum of care indicators yet are important for optimizing maternal and neonatal health and wellbeing. Significant logistical, sociodemographic and sociocultural barriers impede postpartum care access in India including postpartum seclusion, women's limited mobility, and geography. To overcome these barriers and reduce women's postpartum isolation through social support, an international team of maternal and infant health researchers and clinicians developed and pilot-tested a culturally-tailored mobile interactive education and support group intervention to supplement standard postpartum care activities: Maa Shishu Swasthya Sahayak Samooh (maternal and child health support group: MeSSSSage). MeSSSSage uses a provider-moderated group approach to increase women's communication with providers, to refer them to in-person care, and to connect them with a virtual social support group. Participants are recruited in late pregnancy and have 26 education and support sessions via audioconference facilitated by community health workers (two prenatal and weekly postpartum sessions through six months), plus engage in a text chat group. Group-based mHealth models are low cost and likely to be cost-effective. The participants overcome logistical and sociocultural barriers to postnatal care, and the participants have high acceptability and efficiency when used for other health issues. The pilot study results indicated high acceptability and feasibility and suggest preliminary effectiveness on maternal knowledge of best practices for facilitating postpartum health. Understanding intervention effectiveness on maternal health behaviors, key intervention pathways, and cost-effectiveness will inform the scalability of this intervention, with the potential to inform other similar ones.

The goal of this study is to assess the effectiveness of the 8-month MeSSSSage intervention in comparison to standard care alone on health-related behaviors and health outcomes in a fully powered randomized study, to test the conceptual model through analyzing the intervention's mechanisms of impact, and to determine cost-effectiveness. The investigators propose a randomized controlled trial (RCT) among 2100 postpartum Indian women living in 3 geographically diverse Indian states to estimate the impact of MeSSSSage on maternal and neonatal health-related knowledge, health-related behaviors, and health outcomes. The specific aims are to:

Aim 1: Estimate the effectiveness of a mobile interactive education and support group intervention (MeSSSSage) on postpartum behaviors for optimizing maternal and neonatal health in India. Within the 8-month RCT, the investigators will test the impact of the MeSSSSage intervention compared to standard care within 2100 Indian women. The primary effectiveness outcomes are exclusive breastfeeding, met need for postpartum contraceptives, and postpartum mental health. Secondary outcomes will incorporate additional maternal health behaviors and maternal and neonatal outcomes (e.g., appropriate care-seeking for illness, etc. see Table 2).

Aim 2: Characterize the mechanisms of impact of a mobile interactive education and support group intervention (MeSSSSage) on maternal and neonatal health in India. Within this RCT, the investigators will delineate the specific pathways through which the MeSSSSage intervention operates, including knowledge, social support, self-efficacy, and behavior change. The investigators will conduct mediation analyses using modern structural equation modeling and causal inference methods to identify the main drivers of the intervention impact to inform scalability.

Aim 3: Determine the cost-effectiveness of a mobile interactive education and support group intervention (MeSSSSage) in improving postpartum maternal and neonatal health as compared to the standard of care. The investigators will conduct cost analyses to determine intervention and standard of care costs, paying special attention to the value of social network belonging, and calculating opportunity cost. The investigators will conduct cost-effectiveness analysis (CEA) overall and stratified by social connectedness level to estimate the incremental cost-effectiveness ratio (ICER) of MeSSSSage in increasing exclusive breastfeeding, met need for postpartum contraception, and reducing postpartum depression, as compared to standard of care.

Perinatal educational and social support interventions are important for both physical and emotional well-being. The investigators anticipate that supplementing women's perinatal care within the postnatal period through an intervention approach that overcomes prevalent logistical and sociocultural challenges to care access through mHealth will have tangible impacts on the health and well-being of new mothers and infants. Estimating the impact of a mobile group intervention on maternal and infant health will inform scale-up of this accessible, acceptable, and feasible intervention among perinatal South Asian women, and can broadly inform the optimization of perinatal group care models for ensuring continuity across the full continuum of care.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	2100 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Intervention Model Description:	The 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. This model will be tested against the standard of care (3 postnatal visits in the first 7 days postpartum).
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Effectiveness of an mHealth Interactive Education and Social Support Intervention for Improving Postnatal Health
Estimated Study Start Date :	July 1, 2024
Estimated Primary Completion Date :	June 30, 2027
Estimated Study Completion Date :	June 30, 2027

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Depression

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention Arm The 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.	Behavioral: MESSSSAGE intervention group mHealth education and social support intervention
No Intervention: Control Arm Standard postnatal care.

Arm

Intervention/treatment

Experimental: Intervention Arm

The 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.

Behavioral: MESSSSAGE intervention

group mHealth education and social support intervention

No Intervention: Control Arm

Standard postnatal care.

Outcome Measures

Primary Outcome Measures :

Exclusive breastfeeding [ Time Frame: 6 months ]
Proportion of participants reporting exclusive breastfeeding at 3 and 6 months
Postpartum depression [ Time Frame: 6 months ]
Proportion of participants reporting postpartum depression symptoms at 3 and 6 months
Postpartum family planning adoption [ Time Frame: 6 months ]
Proportion of participants not wanting to become pregnant immediately having started a modern contraceptive method within 6 months postpartum

Secondary Outcome Measures :

Maternal and neonatal danger sign knowledge [ Time Frame: 6 months ]
Proportion of participants correctly identifying all maternal and neonatal danger signs by 6 months
Maternal and neonatal health care use [ Time Frame: 6 months ]
Proportion of participants seeking healthcare for maternal and neonatal concerns within 6 months
Neonatal preventive health care use [ Time Frame: 6 months ]
Proportion of participants having achieved target neonatal preventive care visits within 6 months
Infant vaccination [ Time Frame: 6 months ]
Proportion of participants having achieved recommended childhood vaccination schedule by 6 months

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:	18 Years to 49 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Pregnant (28-32 weeks gestational age)
Speak local language
Personal mobile phone or willing to accept study phone
Able to provide informed consent

Exclusion Criteria:

Do not speak local language
No personal phone or unwilling to accept study phone
Unable to provide informed consent

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05268588

Contacts

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Contact: Alison M El Ayadi, ScD	415-476-5877	alison.elayadi@ucsf.edu
Contact: Nadia G Diamond-Smith, PhD	415-476-5616	nadia.diamond-smith@ucsf.edu

Locations

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India
Indraprastha Institute for Information Technology
New Delhi, Delhi, India
Contact: Pushpendra Singh, PhD psingh@iiitd.ac.in
Post-Graduate Institute for Medical Education and Research
Chandigarh, Haryana, India
Contact: Mona Duggal, MD mona.duggal2@gmail.com
Sangath
Bhopal, Madhya Pradesh, India

Sponsors and Collaborators

University of California, San Francisco

Post Graduate Institute of Medical Education and Research, Chandigarh

Indraprastha Institute of Information Technology

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

Sangath

Investigators

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Principal Investigator:	Alison M El Ayadi, ScD	University of California, San Francisco
Principal Investigator:	Nadia G Diamond-Smith, PhD	University of California, San Francisco

More Information

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Responsible Party:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT05268588
Other Study ID Numbers:	P0555059 R01HD108510 ( U.S. NIH Grant/Contract )
First Posted:	March 7, 2022 Key Record Dates
Last Update Posted:	April 3, 2024
Last Verified:	April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	After study completion, de-identified data will be made available to other researchers upon reasonable request and completion of a data sharing agreement.
Supporting Materials:	Study Protocol Statistical Analysis Plan (SAP)
Time Frame:	On study completion
Access Criteria:	Request of study team.

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by University of California, San Francisco:


mHealth group care

Additional relevant MeSH terms:

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Depression, Postpartum Puerperal Disorders Pregnancy Complications Female Urogenital Diseases and Pregnancy Complications	Urogenital Diseases Depressive Disorder Mood Disorders Mental Disorders

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