Health AttitudeMESSAGENCT04693585
Development and Pilot Test of a Postnatal mHealth Intervention - Phase 2
A study testing MESSSSAGE - live and MESSSSAGE - asynchronous in people with Health Attitude and Knowledge, Attitudes, Practice, run by University of California, San Francisco at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Health Attitude, Knowledge, Attitudes, Practice, Post Partum Depression
- What is being tested?
- MESSSSAGE - live and MESSSSAGE - asynchronous
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteIndia
- Study dates
- 30 Jul 2021to 15 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Postnatal (within 2 weeks)
- 18+ years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Post Graduate Institute for Medical Education and Research
Chandigarh
About this study
Official title: Development and Pilot Test of an mHealth Interactive Education and Social Support Intervention for Improving Postnatal Health - Phase 2
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.
Read the detailed description
Most mHealth interventions for maternal and child health (MCH) in low and middle-income countries, including India, have focused on unidirectional and non-interactive approaches, primarily text messaging. However, ample evidence suggests that provider-led, interactive educational programming and social support are key for improving health behaviors and outcomes. Thus innovative mHealth approaches that promote interactive education and facilitate social support have great potential to improve MCH outcomes. The two-phase development of MeSSSSage include sPhase 1: exploratory development on functions and platforms and Phase 2: a mixed-methods randomized pilot study using a factorial design of specific intervention functions and platforms confirmed in Phase 1. Study activities described herein are associated with Phase 1. The study's specific aim is: To test the optimized intervention to understand the feasibility, acceptability and preliminary effectiveness of several intervention modalities among postnatal women in rural India. In Phase 2, the investigators conduct a randomized factorial design to understand the contribution to various intervention modalities on feasibility, accessibility and preliminary effectiveness. Data are collected via quantitative participant survey (baseline and endline) including sociodemographic characteristics and knowledge about maternal and infant health, self-efficacy, and perceived social norms regarding MCH-related health promoting behaviors (baseline) acceptability questions such as women's satisfaction with and perceptions of MeSSSSage, maternal and infant knowledge-, behavior-, and health-related questions including about breastfeeding, complementary food introduction, immunization, family planning uptake, maternal physical and mental health, etc. The investigators will validate self-report with health records. The investigators will conduct in-depth interviews among a purposive sample of 30 women to understand: mobile technology familiarity prior to intervention, perspectives on intervention and challenges, structure of intervention (group, individual), content, perspectives on the text-based component, relationship with other participants, perspective on the moderator, postnatal period health related concerns, sources of support (social and informational), recommendations. Other assessment will include technological data from, and group moderator surveys and interviews.
- Conditions
- Health Attitude, Knowledge, Attitudes, Practice, Post Partum Depression, Acceptability of Health Care
- Being tested
- MESSSSAGE - live, MESSSSAGE - asynchronous
- Medical subject headings
- Behavior, Depression, Postpartum, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MESSSSAGE - liveBehavioural
mHealth education and social support intervention, synchronous via call
MESSSSAGE - asynchronousBehavioural
mHealth education and social support intervention, asynchronous via text
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: live support | Experimental | Real-time live voice call plus standard of postnatal care. Receives: Behavioral: MESSSSAGE - live |
| Arm 2: asynchronous support | Experimental | Text-based, asynchronous, on-demand social support plus standard of postnatal care Receives: 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 Receives: Behavioral: MESSSSAGE - live; Behavioral: MESSSSAGE - asynchronous |
| Arm 4: control | No intervention | Standard of postnatal care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Number of Participants Engaging in Group Call Intervention
Number of participants who engaged in weekly group call intervention activities by 6 months
Measured: 6 months
Secondary outcomes (4)
Number of Participants With Knowledge on Maternal and Neonatal Danger Signs, Best Practices for Infant Care, Family Planning.
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.
Measured: 6 months
Number of Participants Exclusively Breastfeeding
Number of participants who exclusively breastfed their infants through 6 months of age
Measured: 6 months
Number of Participants Reporting Postpartum Depression
Number of participants reporting postpartum depression symptoms at six months
Measured: 6 months
Number of Participants Who Adopted Postpartum Family Planning
Number of participants who started a modern contraceptive methods within 6 months postpartum
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 posted5 Jan 2021
- Study start30 Jul 2021
- Primary completion15 Nov 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health AttitudeStudies 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
- Factorial
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles, Post Graduate Institute of Medical Education and Research, Chandigarh, Indraprastha Institute of Information Technology Delhi, Survival for Women and Children Foundation, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- 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
- NCT04693585
- Sponsor's protocol ID
- R21HD101786-A
- Other IDs
- R21HD101786
- Acronym
- MESSAGE
- Status last verified
- May 2024
- First submitted
- 30 Dec 2020
- Last updated
- 12 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39980038
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Pilot Test of an mHealth Interactive Education and Social Support Intervention for Improving Postnatal Health - Phase 2
- ClinicalTrials.gov ID
- NCT04693585
- Acronym / sponsor ID
- MESSAGE / R21HD101786-A
- Conditions
- Health Attitude, Knowledge, Attitudes, Practice, Post Partum Depression, Acceptability of Health Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, Post Graduate Institute of Medical Education and Research, Chandigarh, Indraprastha Institute of Information Technology Delhi, Survival for Women and Children Foundation, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 30 Jul 2021 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 5 Jan 2021 (actual)
- Results
- Posted 12 Jun 2024
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 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.
Detailed description
Most mHealth interventions for maternal and child health (MCH) in low and middle-income countries, including India, have focused on unidirectional and non-interactive approaches, primarily text messaging. However, ample evidence suggests that provider-led, interactive educational programming and social support are key for improving health behaviors and outcomes. Thus innovative mHealth approaches that promote interactive education and facilitate social support have great potential to improve MCH outcomes. The two-phase development of MeSSSSage include sPhase 1: exploratory development on functions and platforms and Phase 2: a mixed-methods randomized pilot study using a factorial design of specific intervention functions and platforms confirmed in Phase 1. Study activities described herein are associated with Phase 1. The study's specific aim is: To test the optimized intervention to understand the feasibility, acceptability and preliminary effectiveness of several intervention modalities among postnatal women in rural India. In Phase 2, the investigators conduct a randomized factorial design to understand the contribution to various intervention modalities on feasibility, accessibility and preliminary effectiveness. Data are collected via quantitative participant survey (baseline and endline) including sociodemographic characteristics and knowledge about maternal and infant health, self-efficacy, and perceived social norms regarding MCH-related health promoting behaviors (baseline) acceptability questions such as women's satisfaction with and perceptions of MeSSSSage, maternal and infant knowledge-, behavior-, and health-related questions including about breastfeeding, complementary food introduction, immunization, family planning uptake, maternal physical and mental health, etc. The investigators will validate self-report with health records. The investigators will conduct in-depth interviews among a purposive sample of 30 women to understand: mobile technology familiarity prior to intervention, perspectives on intervention and challenges, structure of intervention (group, individual), content, perspectives on the text-based component, relationship with other participants, perspective on the moderator, postnatal period health related concerns, sources of support (social and informational), recommendations. Other assessment will include technological data from, and group moderator surveys and interviews.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Arm 1: live support | Experimental | Behavioral: MESSSSAGE - liveReal-time live voice call plus standard of postnatal care. |
| Arm 2: asynchronous support | Experimental | Behavioral: MESSSSAGE - asynchronousText-based, asynchronous, on-demand social support plus standard of postnatal care |
| Arm 3: both live and asynchronous support | Experimental | Behavioral: MESSSSAGE - live, Behavioral: MESSSSAGE - asynchronousReal-time live voice call plus standard of postnatal care; text-based, asynchronous, on-demand social support plus standard of postnatal care |
| Arm 4: control | No intervention | –Standard of postnatal care. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Postnatal (within 2 weeks)
- 18+ years old
Key exclusion criteria (3 listed)
- 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
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 - livemHealth education and social support intervention, synchronous via call | Behavioural | Arm 1: live support, Arm 3: both live and asynchronous support |
| MESSSSAGE - asynchronousmHealth education and social support intervention, asynchronous via text | Behavioural | Arm 2: asynchronous support, Arm 3: both live and asynchronous support |
Primary outcome
Number of Participants Reporting Being Satisfied or Very Satisfied About Their Overall Intervention Experience
Time frame: 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.
Number of Participants Engaging in Group Call Intervention
Time frame: 6 months
Number of participants who engaged in weekly group call intervention activities by 6 months
4 secondary outcomes
Number of Participants With Knowledge on Maternal and Neonatal Danger Signs, Best Practices for Infant Care, Family Planning.
Time frame: 6 months
Number of Participants Exclusively Breastfeeding
Time frame: 6 months
Number of Participants Reporting Postpartum Depression
Time frame: 6 months
Number of Participants Who Adopted Postpartum Family Planning
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39980038Cox 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Alison M El Ayadi, ScD principal investigator
University of California, San Francisco
Nadia G Diamond-Smith, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MESSSSAGE - live and MESSSSAGE - asynchronous in people with Health Attitude and Knowledge, Attitudes, Practice, run by University of California, San Francisco at 1 site 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 2 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: finished, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 12 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Reporting Being Satisfied or Very Satisfied About Their Overall Intervention Experience (time frame: 6 months). The study lists 2 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 NCT04693585, 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 12 Jun 2024.