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| ID | Type | Description | Link |
|---|---|---|---|
| R21HD101786 | U.S. NIH Grant/Contract | View source |
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| 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 |
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This study is a six-week exploratory developmental phase (phase 1) of a larger project to develop an mHealth intervention targeting health education and social support for Indian women in the postnatal period. Phase 1 of the trial exposes study participants to various intervention modalities and seeks to understand their experiences and perspectives on these using mixed-methods. Results from this trial will inform modifications to the intervention to be tested in Phase 2.
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 will include Phase 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 develop optimal intervention functions, processes, and mHealth platforms for education and peer support among postnatal women in rural India. In Phase 1, the investigators will explore potential interactive education and peer support group intervention functions (education, emotional support, instrumental support, referrals, linkages, follow-up on postnatal visits), processes (group interactions; frequency, length and timing of groups; engagement opportunities, participant profiles) and mHealth delivery platforms (voice, text chat, app options, interaction features). This six-week developmental component will include up to four groups (n=48; 12 per group) to assess different modalities and functions. The investigators will ascertain women's preferences for functions, processes, and platform features using survey and in-depth interviews (IDIs), and capture levels of engagement via back-end data. This process will also inform the intervention's health information content. Findings will be used to formalize the group mobile intervention details to be examined in Phase 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MESSAGE mHealth group intervention | Experimental | Participants in the one arm will be exposed to the mHealth group intervention. As this is a pilot developmental study, the participants will be exposed to various strategies for information delivery (live presentation at a scheduled time versus voice recording accessible at any time), discussion facilitation (heavily managed with request to speak vs. natural discussion participation), and text communication management (moderator-facilitated vs. group-led). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MESSAGE - mHealth intervention | Behavioral | A group-based moderated six-week intervention with didactic, discussion, and text communication components. |
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| Measure | Description | Time Frame |
|---|---|---|
| Satisfied or Very Satisfied About Their Overall Intervention Experience | Proportion of participants reporting to be "satisfied" or "very satisfied" with their overall intervention experience, assessed through a five-point Likert scale at six weeks. | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alison 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 (PGIMER) | Chandigarh | India |
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| ID | Title | Description |
|---|---|---|
| FG000 | MESSAGE mHealth Group Intervention | Participants in the one arm will be exposed to the mHealth group intervention. As this is a pilot developmental study, the participants will be exposed to various strategies for information delivery (live presentation at a scheduled time versus voice recording accessible at any time), discussion facilitation (heavily managed with request to speak vs. natural discussion participation), and text communication management (moderator-facilitated vs. group-led). MESSAGE - mHealth intervention: A group-based moderated six-week intervention with didactic, discussion, and text communication components. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | MESSAGE mHealth Group Intervention | Participants in the one arm will be exposed to the mHealth group intervention. As this is a pilot developmental study, the participants will be exposed to various strategies for information delivery (live presentation at a scheduled time versus voice recording accessible at any time), discussion facilitation (heavily managed with request to speak vs. natural discussion participation), and text communication management (moderator-facilitated vs. group-led). MESSAGE - mHealth intervention: A group-based moderated six-week intervention with didactic, discussion, and text communication components. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Satisfied or Very Satisfied About Their Overall Intervention Experience | Proportion of participants reporting to be "satisfied" or "very satisfied" with their overall intervention experience, assessed through a five-point Likert scale at six weeks. | We were unable to recruit an additional person to reach our target sample size of 30 within the time frame and criteria required for the group-oriented intervention. | Posted | Count of Participants | Participants | 6 weeks |
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6 weeks of intervention participation
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MESSAGE mHealth Group Intervention | Participants in the one arm will be exposed to the mHealth group intervention. As this is a pilot developmental study, the participants will be exposed to various strategies for information delivery (live presentation at a scheduled time versus voice recording accessible at any time), discussion facilitation (heavily managed with request to speak vs. natural discussion participation), and text communication management (moderator-facilitated vs. group-led). MESSAGE - mHealth intervention: A group-based moderated six-week intervention with didactic, discussion, and text communication components. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alison El Ayadi | University of California San Francisco | 415-659-8367 | alison.elayadi@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 1, 2020 | Jul 24, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 1, 2020 | Jul 24, 2022 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 28, 2020 | Jul 24, 2022 | ICF_002.pdf |
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| 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 |
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| Survival for Women and Children Foundation | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
Non-randomized quasi-experimental exploratory study. All small groups will receive the same intervention which is exposure to a variety of intervention modalities (3 main modalities: information delivery, facilitation strategy, text management).
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Personal smartphone | Number | participants |
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| Educational attainment | Count of Participants | Participants |
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| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
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| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |