Development and Pilot Test of a Postnatal mHealth Intervention - Phase 2 (MESSAGE)
Primary Purpose
Health Attitude, Knowledge, Attitudes, Practice, Post Partum Depression
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
MESSSSAGE - live
MESSSSAGE - asynchronous
Sponsored by
About this trial
This is an interventional prevention trial for Health Attitude
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
Sites / Locations
- Post Graduate Institute for Medical Education and Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
Arm 1: live support
Arm 2: asynchronous support
Arm 3: both live and asynchronous support
Arm 4: control
Arm Description
Real-time live voice call plus standard of postnatal care.
Text-based, asynchronous, on-demand social support plus standard of postnatal care
Real-time live voice call plus standard of postnatal care; text-based, asynchronous, on-demand social support plus standard of postnatal care
Standard of postnatal care.
Outcomes
Primary Outcome Measures
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 months.
Participation rate
Weekly engagement in intervention activities by 6 months
Secondary Outcome Measures
Knowledge on maternal and neonatal danger signs, best practices for infant care, family planning.
Proportion 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.
Exclusive breastfeeding
Proportion of participants exclusively breastfeeding their infants through 6 months of age
Postpartum depression
Proportion of participants reporting postpartum depression symptoms at six weeks, three months and six months
Postpartum family planning adoption
Proportion of participants having started a modern contraceptive methods within 6 months postpartum
Full Information
NCT ID
NCT04693585
First Posted
December 30, 2020
Last Updated
August 28, 2023
Sponsor
University of California, San Francisco
Collaborators
University of California, Los Angeles, Postgraduate 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)
1. Study Identification
Unique Protocol Identification Number
NCT04693585
Brief Title
Development and Pilot Test of a Postnatal mHealth Intervention - Phase 2
Acronym
MESSAGE
Official Title
Development and Pilot Test of an mHealth Interactive Education and Social Support Intervention for Improving Postnatal Health - Phase 2
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
July 30, 2021 (Actual)
Primary Completion Date
November 15, 2022 (Actual)
Study Completion Date
November 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
University of California, Los Angeles, Postgraduate 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)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Health Attitude, Knowledge, Attitudes, Practice, Post Partum Depression, Acceptability of Health Care
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
201 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: live support
Arm Type
Experimental
Arm Description
Real-time live voice call plus standard of postnatal care.
Arm Title
Arm 2: asynchronous support
Arm Type
Experimental
Arm Description
Text-based, asynchronous, on-demand social support plus standard of postnatal care
Arm Title
Arm 3: both live and asynchronous support
Arm Type
Experimental
Arm Description
Real-time live voice call plus standard of postnatal care; text-based, asynchronous, on-demand social support plus standard of postnatal care
Arm Title
Arm 4: control
Arm Type
No Intervention
Arm Description
Standard of postnatal care.
Intervention Type
Behavioral
Intervention Name(s)
MESSSSAGE - live
Intervention Description
mHealth education and social support intervention, synchronous via call
Intervention Type
Behavioral
Intervention Name(s)
MESSSSAGE - asynchronous
Intervention Description
mHealth education and social support intervention, asynchronous via text
Primary Outcome Measure Information:
Title
Satisfied or very satisfied about their overall intervention experience
Description
Proportion of participants reporting to be "satisfied" or "very satisfied" with their overall intervention experience, assessed through a five-point Likert scale at six months.
Time Frame
6 months
Title
Participation rate
Description
Weekly engagement in intervention activities by 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Knowledge on maternal and neonatal danger signs, best practices for infant care, family planning.
Description
Proportion 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
Title
Exclusive breastfeeding
Description
Proportion of participants exclusively breastfeeding their infants through 6 months of age
Time Frame
6 months
Title
Postpartum depression
Description
Proportion of participants reporting postpartum depression symptoms at six weeks, three months and six months
Time Frame
6 weeks, 3 months, 6 months
Title
Postpartum family planning adoption
Description
Proportion of participants having started a modern contraceptive methods within 6 months postpartum
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alison M El Ayadi, ScD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nadia G Diamond-Smith, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Post Graduate Institute for Medical Education and Research
City
Chandigarh
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Development and Pilot Test of a Postnatal mHealth Intervention - Phase 2
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