Clinical trial NCT04636398: Postnatal mHealth Intervention Development
Official title: Development and Pilot Test of an mHealth Interactive Education and Social Support Intervention for Improving Postnatal Health - Phase 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Attitude
Knowledge, Attitudes, Practice
Postpartum 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: 2020-11-19
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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).
Primary purpose: PREVENTION

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.

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: Satisfied or Very Satisfied About Their Overall Intervention Experience
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Post Graduate Institute for Medical Education and Research (PGIMER)
Study officials:
affiliation: University of California, San Francisco
name: Alison El Ayadi, ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Nadia G Diamond-Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References: