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Development and Pilot Test of a Postnatal mHealth Intervention - Phase 2 (MESSAGE)

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ClinicalTrials.gov Identifier: NCT04693585
Recruitment Status : Recruiting
First Posted : January 5, 2021
Last Update Posted : November 10, 2021
Sponsor:
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)
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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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.

Condition or disease Intervention/treatment Phase
Health Attitude Knowledge, Attitudes, Practice Post Partum Depression Acceptability of Health Care Behavioral: MESSSSAGE - live Behavioral: MESSSSAGE - asynchronous Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
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).
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Development and Pilot Test of an mHealth Interactive Education and Social Support Intervention for Improving Postnatal Health - Phase 2
Actual Study Start Date : July 30, 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1: live support
Real-time live voice call plus standard of postnatal care.
 Behavioral: MESSSSAGE - live
mHealth education and social support intervention, synchronous via call
Experimental: Arm 2: asynchronous support
Text-based, asynchronous, on-demand social support plus standard of postnatal care
 Behavioral: MESSSSAGE - asynchronous
mHealth education and social support intervention, asynchronous via text
Experimental: Arm 3: both live and asynchronous support
Real-time live voice call plus standard of postnatal care; text-based, asynchronous, on-demand social support plus standard of postnatal care
 Behavioral: MESSSSAGE - live
mHealth education and social support intervention, synchronous via call

Behavioral: MESSSSAGE - asynchronous
mHealth education and social support intervention, asynchronous via text
No Intervention: Arm 4: control
Standard of postnatal care.


Outcome Measures
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Primary Outcome Measures :
  1. Satisfied or very satisfied about their overall intervention experience [ Time Frame: 6 months ]
    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.

  2. Participation rate [ Time Frame: 6 months ]
    Weekly engagement in intervention activities by 6 months


Secondary Outcome Measures :
  1. Knowledge on maternal and neonatal danger signs, best practices for infant care, family planning. [ Time Frame: 6 months ]
    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.

  2. Exclusive breastfeeding [ Time Frame: 6 months ]
    Proportion of participants exclusively breastfeeding their infants through 6 months of age

  3. Postpartum depression [ Time Frame: 6 weeks, 3 months, 6 months ]
    Proportion of participants reporting postpartum depression symptoms at six weeks, three months and six months

  4. Postpartum family planning adoption [ Time Frame: 6 months ]
    Proportion of participants having started a modern contraceptive methods within 6 months postpartum


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04693585


Contacts
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Contact: Alison M El Ayadi, ScD 6178777424 alison.elayadi@ucsf.edu
Contact: Nadia G Diamond-Smith, PhD 5109144586 nadia.diamond-smith@ucsf.edu

Locations
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India
Community level Recruiting
Chandigarh, India
Contact: Rashmi Bagga, MD         
Sponsors and Collaborators
University of California, San Francisco
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)
Investigators
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Principal Investigator: Alison M El Ayadi, ScD University of California, San Francisco
Principal Investigator: Nadia G Diamond-Smith, PhD University of California, San Francisco
More Information
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04693585    
Other Study ID Numbers: R21HD101786-A
R21HD101786 ( U.S. NIH Grant/Contract )
First Posted: January 5, 2021    Key Record Dates
Last Update Posted: November 10, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression, Postpartum
Puerperal Disorders
Pregnancy Complications
 Depressive Disorder
Mood Disorders
Mental Disorders