Acceptability of Health Care, Health Attitude, Knowledge, Attitudes, Practice, Post Partum Depression
Conditions
Brief 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. 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.
Interventions
mHealth education and social support intervention, synchronous via call
mHealth education and social support intervention, asynchronous via text
Sponsors
Study design
Intervention 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).
Eligibility
Inclusion criteria
* Postnatal (within 2 weeks) * 18+ years old
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Being Satisfied or Very Satisfied About Their Overall Intervention Experience | 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 | 6 months | Number of participants who engaged in weekly group call intervention activities by 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Knowledge on Maternal and Neonatal Danger Signs, Best Practices for Infant Care, Family Planning. | 6 months | 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. |
| Number of Participants Exclusively Breastfeeding | 6 months | Number of participants who exclusively breastfed their infants through 6 months of age |
| Number of Participants Reporting Postpartum Depression | 6 months | Number of participants reporting postpartum depression symptoms at six months |
| Number of Participants Who Adopted Postpartum Family Planning | 6 months | Number of participants who started a modern contraceptive methods within 6 months postpartum |
Countries
India
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 120 |
| Arm 2: Asynchronous Support Asynchronous: Audio-based education via mobile application or interactive voice response on-demand Other: standard of postnatal care | 40 |
| Arm 3: Control Other: Standard of postnatal care. | 41 |
| Total | 201 |
Baseline characteristics
| Characteristic | Arm 1: Synchronous and Asynchronous Support | Arm 2: Asynchronous Support | Arm 3: Control | Total |
|---|---|---|---|---|
| Age, Continuous | 26.7 years STANDARD_DEVIATION 3.7 | 26.1 years STANDARD_DEVIATION 3.4 | 26.8 years STANDARD_DEVIATION 4.9 | 26.6 years STANDARD_DEVIATION 3.9 |
| Race/Ethnicity, Customized Indian | 120 Participants | 40 Participants | 41 Participants | 201 Participants |
| Region of Enrollment India | 120 participants | 40 participants | 41 participants | 201 participants |
| Sex: Female, Male Female | 120 Participants | 40 Participants | 41 Participants | 201 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 94 | 0 / 28 | 0 / 13 |
| other Total, other adverse events | 0 / 94 | 0 / 28 | 0 / 13 |
| serious Total, serious adverse events | 0 / 94 | 0 / 28 | 0 / 13 |
Outcome results
Number of Participants Engaging in Group Call Intervention
Number of participants who engaged in weekly group call intervention activities by 6 months
Time frame: 6 months
Population: Group call intervention activities only relevant to arm 1.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1: Synchronous and Asynchronous Support | Number of Participants Engaging in Group Call Intervention | 37 Participants |
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.
Time frame: 6 months
Population: Control group participants did not answer questions about intervention experience
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1: Synchronous and Asynchronous Support | Number of Participants Reporting Being Satisfied or Very Satisfied About Their Overall Intervention Experience | 90 Participants |
| Arm 2: Asynchronous Support | Number of Participants Reporting Being Satisfied or Very Satisfied About Their Overall Intervention Experience | 19 Participants |
Number of Participants Exclusively Breastfeeding
Number of participants who exclusively breastfed their infants through 6 months of age
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1: Synchronous and Asynchronous Support | Number of Participants Exclusively Breastfeeding | 79 Participants |
| Arm 2: Asynchronous Support | Number of Participants Exclusively Breastfeeding | 18 Participants |
| Arm 3: Control | Number of Participants Exclusively Breastfeeding | 11 Participants |
Number of Participants Reporting Postpartum Depression
Number of participants reporting postpartum depression symptoms at six months
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1: Synchronous and Asynchronous Support | Number of Participants Reporting Postpartum Depression | 43 Participants |
| Arm 2: Asynchronous Support | Number of Participants Reporting Postpartum Depression | 10 Participants |
| Arm 3: Control | Number of Participants Reporting Postpartum Depression | 5 Participants |
Number of Participants Who Adopted Postpartum Family Planning
Number of participants who started a modern contraceptive methods within 6 months postpartum
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1: Synchronous and Asynchronous Support | Number of Participants Who Adopted Postpartum Family Planning | 67 Participants |
| Arm 2: Asynchronous Support | Number of Participants Who Adopted Postpartum Family Planning | 14 Participants |
| Arm 3: Control | Number of Participants Who Adopted Postpartum Family Planning | 10 Participants |
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.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1: Synchronous and Asynchronous Support | Number of Participants With Knowledge on Maternal and Neonatal Danger Signs, Best Practices for Infant Care, Family Planning. | 0 Participants |
| Arm 2: Asynchronous Support | Number of Participants With Knowledge on Maternal and Neonatal Danger Signs, Best Practices for Infant Care, Family Planning. | 0 Participants |
| Arm 3: Control | Number of Participants With Knowledge on Maternal and Neonatal Danger Signs, Best Practices for Infant Care, Family Planning. | 0 Participants |