Clinical trial NCT04693585: Development and Pilot Test of a Postnatal mHealth Intervention - Phase 2
Official title: Development and Pilot Test of an mHealth Interactive Education and Social Support Intervention for Improving Postnatal Health - Phase 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Attitude
Knowledge, Attitudes, Practice
Post Partum Depression
Acceptability of Health Care
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: Post Graduate Institute of Medical Education and Research, Chandigarh
name: Indraprastha Institute of Information Technology Delhi
name: Survival for Women and Children Foundation
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-01-05
Enrollment: 201
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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).
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Reporting Being Satisfied or Very Satisfied About Their Overall Intervention Experience
timeFrame: 6 months
measure: Number of Participants Engaging in Group Call Intervention
timeFrame: 6 months
Secondary outcomes:
measure: Number of Participants With Knowledge on Maternal and Neonatal Danger Signs, Best Practices for Infant Care, Family Planning.
timeFrame: 6 months
measure: Number of Participants Exclusively Breastfeeding
timeFrame: 6 months
measure: Number of Participants Reporting Postpartum Depression
timeFrame: 6 months
measure: Number of Participants Who Adopted Postpartum Family Planning
timeFrame: 6 months
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Post Graduate Institute for Medical Education and Research
Study officials:
affiliation: University of California, San Francisco
name: Alison M El Ayadi, ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Nadia G Diamond-Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References: