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Postnatal mHealth Intervention Development (MESSAGE)

Primary Purpose

Health Attitude, Knowledge, Attitudes, Practice, Postpartum Depression

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
MESSAGE - mHealth intervention
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Health Attitude

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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 (PGIMER)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MESSAGE mHealth group intervention

Arm Description

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).

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 weeks.

Secondary Outcome Measures

Full Information

First Posted
November 13, 2020
Last Updated
July 25, 2022
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)
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1. Study Identification

Unique Protocol Identification Number
NCT04636398
Brief Title
Postnatal mHealth Intervention Development
Acronym
MESSAGE
Official Title
Development and Pilot Test of an mHealth Interactive Education and Social Support Intervention for Improving Postnatal Health - Phase 1
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
January 30, 2021 (Actual)
Study Completion Date
January 30, 2021 (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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Health Attitude, Knowledge, Attitudes, Practice, Postpartum Depression, Acceptability of Health Care

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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).
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MESSAGE mHealth group intervention
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
MESSAGE - mHealth intervention
Intervention Description
A group-based moderated six-week intervention with didactic, discussion, and text communication components.
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 weeks.
Time Frame
6 weeks

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 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 (PGIMER)
City
Chandigarh
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No

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Postnatal mHealth Intervention Development

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