Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R21HD101786 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of California, Los Angeles | OTHER |
| Post Graduate Institute of Medical Education and Research, Chandigarh | OTHER |
| Indraprastha Institute of Information Technology Delhi | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: live support | Experimental | Real-time live voice call plus standard of postnatal care. |
|
| Arm 2: asynchronous support | Experimental | Text-based, asynchronous, on-demand social support plus standard of postnatal care |
|
| 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 |
|
| Arm 4: control | No Intervention | Standard of postnatal care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MESSSSAGE - live | Behavioral | mHealth education and social support intervention, synchronous via call |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Number of Participants Engaging in Group Call Intervention | Number of participants who engaged in weekly group call intervention activities by 6 months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alison M El Ayadi, ScD | University of California, San Francisco | Principal Investigator |
| Nadia G Diamond-Smith, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Post Graduate Institute for Medical Education and Research | Chandigarh | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39980038 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: Synchronous and Asynchronous Support | Synchronous: Real-time live voice or video call Asynchronous: Audio-based education via mobile application or interactive voice response on-demand Other: standard of postnatal care |
| FG001 | Arm 2: Asynchronous Support | Asynchronous: Audio-based education via mobile application or interactive voice response on-demand Other: standard of postnatal care |
| FG002 | Arm 3: Control | Other: Standard of postnatal care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: Synchronous and Asynchronous Support | Synchronous: Real-time live voice or video call Asynchronous: Audio-based education via mobile application or interactive voice response on-demand Other: standard of postnatal care |
| BG001 | Arm 2: Asynchronous Support |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Control group participants did not answer questions about intervention experience | Posted | Count of Participants | Participants | 6 months |
|
8 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: Synchronous and Asynchronous Support | Synchronous: Real-time live voice or video call Asynchronous: Audio-based education via mobile application or interactive voice response on-demand Other: standard of postnatal care |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nadia Diamond-Smith | University of California San Francisco | 415-353-4545 | nadia.diamond-smith@ucsf.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 1, 2020 | May 16, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 1, 2020 | May 16, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001519 | Behavior |
| D019052 | Depression, Postpartum |
| D010342 | Patient Acceptance of Health Care |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| Survival for Women and Children Foundation | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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).
Not provided
Not provided
Not provided
Not provided
| MESSSSAGE - asynchronous | Behavioral | mHealth education and social support intervention, asynchronous via text |
|
| Number of Participants Exclusively Breastfeeding |
Number of participants who exclusively breastfed their infants through 6 months of age |
| 6 months |
| Number of Participants Reporting Postpartum Depression | Number of participants reporting postpartum depression symptoms at six months | 6 months |
| Number of Participants Who Adopted Postpartum Family Planning | Number of participants who started a modern contraceptive methods within 6 months postpartum | 6 months |
Asynchronous: Audio-based education via mobile application or interactive voice response on-demand Other: standard of postnatal care |
| BG002 | Arm 3: Control | Other: Standard of postnatal care. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Asynchronous: Audio-based education via mobile application or interactive voice response on-demand Other: standard of postnatal care |
| OG002 | Arm 3: Control | Other: Standard of postnatal care. |
|
|
| Primary | Number of Participants Engaging in Group Call Intervention | Number of participants who engaged in weekly group call intervention activities by 6 months | Group call intervention activities only relevant to arm 1. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Number of Participants Exclusively Breastfeeding | Number of participants who exclusively breastfed their infants through 6 months of age | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Number of Participants Reporting Postpartum Depression | Number of participants reporting postpartum depression symptoms at six months | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Number of Participants Who Adopted Postpartum Family Planning | Number of participants who started a modern contraceptive methods within 6 months postpartum | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 0 |
| 94 |
| 0 |
| 94 |
| 0 |
| 94 |
| EG001 | Arm 2: Asynchronous Support | Asynchronous: Audio-based education via mobile application or interactive voice response on-demand Other: standard of postnatal care | 0 | 28 | 0 | 28 | 0 | 28 |
| EG002 | Arm 3: Control | Other: Standard of postnatal care. | 0 | 13 | 0 | 13 | 0 | 13 |
Not provided
Not provided
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |