Acceptability of Health Care, Health Attitude, Knowledge, Attitudes, Practice, Postpartum Depression
Conditions
Brief summary
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.
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 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.
Interventions
BEHAVIORALMESSAGE - mHealth intervention
A group-based moderated six-week intervention with didactic, discussion, and text communication components.
Sponsors
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)
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
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).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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 |
|---|---|---|
| Satisfied or Very Satisfied About Their Overall Intervention Experience | 6 weeks | 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. |
Countries
India
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 29 |
| Total | 29 |
Baseline characteristics
| Characteristic | MESSAGE mHealth Group Intervention |
|---|---|
| Age, Continuous | 25 Years |
| Educational attainment Graduation | 3 Participants |
| Educational attainment Higher primary | 4 Participants |
| Educational attainment Illiterate | 3 Participants |
| Educational attainment Post-Graduation | 3 Participants |
| Educational attainment Primary | 2 Participants |
| Educational attainment Secondary | 3 Participants |
| Educational attainment Senior secondary | 11 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Personal smartphone | 17 participants |
| Region of Enrollment India | 29 participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 29 |
| other Total, other adverse events | 0 / 29 |
| serious Total, serious adverse events | 0 / 29 |
Outcome results
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.
Time frame: 6 weeks
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MESSAGE mHealth Group Intervention | Satisfied or Very Satisfied About Their Overall Intervention Experience | 29 Participants |