Health Knowledge, Attitudes, PracticeKushal MaaNCT05268588
mHealth India Postnatal Health Intervention Effectiveness
A study testing MESSSSAGE intervention in people with Health Knowledge, Attitudes, Practice and Post Partum Depression, run by University of California, San Francisco at 3 sites in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Health Knowledge, Attitudes, Practice, Post Partum Depression, Breastfeeding
- What is being tested?
- MESSSSAGE intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,100 participants
- Where
- 3 sitesIndia
- Study dates
- 20 Jan 2025to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant (28-32 weeks gestational age)
- Speak local language
- Personal mobile phone or willing to accept study phone
- Able to provide informed consent
Who cannot join
- Do not speak local language
- No personal phone or unwilling to accept study phone
- Unable to provide informed consent
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
India3 sites, 3 recruiting
- Recruiting
Sangath
Bhopal, Madhya Pradesh
Anant Bhan, MD, MS, anant.bhan@sangath.in
- Recruiting
Post-Graduate Institute for Medical Education and Research
Chandīgarh, Haryana
Mona Duggal, MD, mona.duggal2@gmail.com
- Not yet recruiting
Indraprastha Institute for Information Technology
New Delhi, National Capital Territory of Delhi
Pushpendra Singh, PhD, psingh@iiitd.ac.in
About this study
Official title: Effectiveness of an mHealth Interactive Education and Social Support Intervention for Improving Postnatal Health
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.
Read the 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.
- Conditions
- Health Knowledge, Attitudes, Practice, Post Partum Depression, Breastfeeding, Nutrition, Healthy
- Being tested
- MESSSSAGE intervention
- Keywords
- mHealth, group care
- Medical subject headings
- Behavior, Depression, Postpartum, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MESSSSAGE interventionBehavioural
group mHealth education and social support intervention
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | 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. Receives: Behavioral: MESSSSAGE intervention |
| Control Arm | No intervention | Standard postnatal care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exclusive breastfeeding
Proportion of participants reporting exclusive breastfeeding at 3 and 6 months
Measured: 6 months
Postpartum depression
Proportion of participants reporting postpartum depression symptoms at 3 and 6 months
Measured: 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
Measured: 6 months
Secondary outcomes (4)
Maternal and neonatal danger sign knowledge
Proportion of participants correctly identifying all maternal and neonatal danger signs by 6 months
Measured: 6 months
Maternal and neonatal health care use
Proportion of participants seeking healthcare for maternal and neonatal concerns within 6 months
Measured: 6 months
Neonatal preventive health care use
Proportion of participants having achieved target neonatal preventive care visits within 6 months
Measured: 6 months
Infant vaccination
Proportion of participants having achieved recommended childhood vaccination schedule by 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start20 Jan 2025
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health Knowledge, Attitudes, PracticeStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 2,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Post Graduate Institute of Medical Education and Research, Chandigarh, Indraprastha Institute of Information Technology Delhi, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Sangath
- Responsible party
- Sponsor
- Investigators
- Alison M El Ayadi, ScD, Principal investigator, University of California, San FranciscoNadia G Diamond-Smith, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268588
- Sponsor's protocol ID
- P0555059
- Other IDs
- R01HD108510
- Acronym
- Kushal Maa
- Status last verified
- Mar 2026
- First submitted
- 24 Feb 2022
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After study completion, de-identified data will be made available to other researchers upon reasonable request and completion of a data sharing agreement.
Publications
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.
PubMed 40578858
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an mHealth Interactive Education and Social Support Intervention for Improving Postnatal Health
- ClinicalTrials.gov ID
- NCT05268588
- Acronym / sponsor ID
- Kushal Maa / P0555059
- Conditions
- Health Knowledge, Attitudes, Practice, Post Partum Depression, Breastfeeding, Nutrition, Healthy
- Keywords
- mHealth, group care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,100 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Post Graduate Institute of Medical Education and Research, Chandigarh, Indraprastha Institute of Information Technology Delhi, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Sangath
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 7 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: MESSSSAGE interventionThe 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 intervention | –Standard postnatal care. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant (28-32 weeks gestational age)
- Speak local language
- Personal mobile phone or willing to accept study phone
- Able to provide informed consent
Key exclusion criteria (3 listed)
- Do not speak local language
- No personal phone or unwilling to accept study phone
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MESSSSAGE interventiongroup mHealth education and social support intervention | Behavioural | Intervention Arm |
Primary outcome
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
4 secondary outcomes
Maternal and neonatal danger sign knowledge
Time frame: 6 months
Maternal and neonatal health care use
Time frame: 6 months
Neonatal preventive health care use
Time frame: 6 months
Infant vaccination
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Derived from this study: PubMed 40578858El 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.
- Individual participant dataSharing planned: Yes. After study completion, de-identified data will be made available to other researchers upon reasonable request and completion of a data sharing agreement.
Related trials for Health Knowledge, Attitudes, Practice
Not yet recruiting
The Effectiveness of Comic-based Learning Materials on Nursing Students' Knowledge, Attitudes, and Confidence in Dementia Care
Dementia Care Education, Students, Nursing
Recruiting
Climate-Responsive Nutrition, WASH, and Heat Counselling for Maternal and Child Health in Sindh, Pakistan
Maternal Nutrition, Child Nutrition
Active, not recruitingPhase 3
PREVENT HPV -Related Cancers Trial
HPV Vaccination, Uptake Vaccination
Active, not recruiting
A Multilevel Intervention to Improve Adherence to Childhood Cancer Survivorship
Childhood Cancer, Survivorship
Not yet recruiting
Pilot Study to Co-create and Implement a Multicomponent Intervention to Reduce Mental Health Stigma in Primary Care
Mental Health, Stigma of Mental Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alison M El Ayadi, ScD principal investigator
University of California, San Francisco
Nadia G Diamond-Smith, PhD principal investigator
University of California, San Francisco
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MESSSSAGE intervention in people with Health Knowledge, Attitudes, Practice and Post Partum Depression, run by University of California, San Francisco at 3 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alison M El Ayadi, ScD (415-476-5877, alison.elayadi@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exclusive breastfeeding (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05268588, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.