Postnatal mHealth Intervention Development

NCT04636398 | Completed Results

• 1 other identifier: R21HD101786
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Attitude; Knowledge, Attitudes, Practice; Postpartum Depression; Acceptability of Health Care

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks

Study Arms (1)

MESSAGE mHealth group intervention

EXPERIMENTAL

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).

Behavioral: MESSAGE - mHealth intervention

Interventions

MESSAGE - mHealth intervention BEHAVIORAL

A group-based moderated six-week intervention with didactic, discussion, and text communication components.

MESSAGE mHealth group intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Postnatal (within 2 weeks)
• + years old

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• University of California, Los Angeles: collaborator
• Post Graduate Institute of Medical Education and Research, Chandigarh: collaborator
• Indraprastha Institute of Information Technology Delhi: collaborator
• Survival for Women and Children Foundation: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Post Graduate Institute for Medical Education and Research (PGIMER)

Chandigarh, India

Location

MeSH Terms

Conditions

Behavior; Depression, Postpartum; Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Treatment Adherence and Compliance; Health Behavior

Results Point of Contact

• Title: Alison El Ayadi
• Organization: University of California San Francisco

alison.elayadi@ucsf.edu

415-659-8367

Study Officials

• Alison El Ayadi, ScD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Nadia G Diamond-Smith, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: November 19, 2020
• Study Start: December 1, 2020
• Primary Completion: January 30, 2021
• Study Completion: January 30, 2021
• Last Updated: June 4, 2024
• Results First Posted: August 19, 2022

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)