Joyuus - A Web-based Tool for Postpartum Care Self-care for Underserved Women

NCT ID: NCT05876559

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 137 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-15
• Study Completion Date: 2024-10-15

Brief Summary

The goal of this RCT is to evaluate the effectiveness of Joyuus on improving maternal functioning with postpartum moms. The main questions it aims to answer are:

• The primary hypothesis is that participants of the Joyuus program will demonstrate improved functional status compared to the control arm participants at 3-month follow-up.
• The secondary hypotheses are that participants using the Joyuus tool will demonstrate improvement in depression, anxiety, resilience, social support, and knowledge compared to the control arm at 6- and 12-weeks follow-up.

Detailed Description

In the United States, the postpartum period is a critical time for both maternal and child health; the US maternal mortality rate is the highest among other developed, high-income countries. More than half of all maternal deaths occur postpartum, from one day to one year after birth. There are vast racial and ethnic disparities in maternal mortality and severe morbidity, disproportionately experienced by Black and Latina mothers and other BIPOC women. Black women are 3-4 times more likely to experience maternal mortality than white women10, and Hispanic women are twice as likely to experience severe maternal outcomes compared with non-Hispanic white women. The American College of Obstetricians and Gynecologists recognized the deficiencies in postpartum care and coined the term the 'fourth trimester' to mark the time following birth through the first 3-months postpartum. They recently updated recommendations to address these challenges. The Biden Build Back Better Act also prioritized this issue. Joyuus is a web-based self-care mobile tool addressing the 12 months postpartum, to reduce the risks of avoidable morbidity and mortality for underserved women. The tool addresses physical, mental, real world, cultural, and knowledge barriers which impact quality postpartum care. Joyuus provides information, resources, expert perspectives, peer communications and red flags presented in a variety of formats to help women identify how to adopt healthy self-care habits. Importantly, it also identifies when self-care leads to seeking provider care. Pregnant women often turn to the internet to find information about their health and their developing baby's health. Yet, studies find that mothers are not finding sufficient resources to match their postpartum needs. The Phase I grant demonstrated in a sample of Black women that this audience is highly engaged across the income and education spectrum and prefers mobile access and text-based communication. In Phase II work will continue to include lived experiences of women most at risk for negative postpartum outcomes as part of the complete tool. The first step will be to conduct a needs assessment to understand informational, cultural and language wants and needs in the Latina population. The broader randomized trial will invite a diverse population of BIPOC and white women. The Phase II scope aims to complete three major tasks:

AIM 1: Expand feasibility activities to address Latina population. Explore self-care (and seeking care) needs for the postpartum Latina community and integrate with the Phase I focus group findings.

AIM 2: Build complete tool. The investigators will complete the development of a fully interactive Joyuus web based mobile tool in English and Spanish.

AIM 3: Test in randomized controlled trial. The investigators will test the effectiveness of Joyuus with a diverse national sample of postpartum women, considering the impact on maternal function, depression, anxiety, resilience, knowledge, and social support.

Conditions

Maternal Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

active intervention group

Participants will receive immediate access to Joyuus selfcare mobile app

Group Type: EXPERIMENTAL

Joyuus Self-care Mobile App

Intervention Type: OTHER

Joyuus is an innovative self-care mobile tool designed to address the needs of underserved women who are at greater risk for adverse postpartum outcomes. It provides the appropriate information, knowledge, and skills to improve postpartum health through self-care, and identifies when it is appropriate to seek care.

standard care control group

Participants will receive standard care, and will not have access to Joyuus selfcare mobile app until study completion.

Group Type: ACTIVE_COMPARATOR

Standard Care

Intervention Type: OTHER

Standard care is access to typical resources women have access to during postpartum and does not include the Joyuus intervention.

Interventions

Joyuus Self-care Mobile App

Joyuus is an innovative self-care mobile tool designed to address the needs of underserved women who are at greater risk for adverse postpartum outcomes. It provides the appropriate information, knowledge, and skills to improve postpartum health through self-care, and identifies when it is appropriate to seek care.

Intervention Type: OTHER

Standard Care

Standard care is access to typical resources women have access to during postpartum and does not include the Joyuus intervention.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Must be age 18 or older
• Must be between 0-6 months postpartum
• Must have a smartphone with internet access and are willing to use this device to participate in all study activities; and
• Must be able to speak, read, and write in English

Exclusion Criteria

• Medical/health issues which would impact participants' health or ability to participate
• Did not have a live birth

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

Joyuus, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Lisa Marceau

Westerly, Rhode Island, United States

Countries

United States

Other Identifiers

R44MD014923

Identifier Type: NIH

Identifier Source: secondary_id

View Link

p-20167

Identifier Type: -

Identifier Source: org_study_id