Maternal HealthNCT05876559
Joyuus - A Web-based Tool for Postpartum Care Self-care for Underserved Women
A study testing Joyuus Self-care Mobile App in people with Maternal Health, run by Joyuus, LLC at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Maternal Health
- What is being tested?
- Joyuus Self-care Mobile App
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2024to 15 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Medical/health issues which would impact participants' health or ability to participate
- Did not have a live birth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Joyuus: A Web-based Tool for Postpartum Care Self-care to Address the Complex Needs of Underserved Women
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.
Read the 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
- Being tested
- Joyuus Self-care Mobile App, Standard Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Joyuus Self-care Mobile AppOther
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 CareOther
Standard care is access to typical resources women have access to during postpartum and does not include the Joyuus intervention.
| Study group | Role | What they receive |
|---|---|---|
| active intervention group | Experimental | Participants will receive immediate access to Joyuus selfcare mobile app Receives: Other: Joyuus Self-care Mobile App |
| standard care control group | Active comparator | Participants will receive standard care, and will not have access to Joyuus selfcare mobile app until study completion. Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barkin Index of Maternal Functioning (BIMF)
The BIMF is a 20-item self-report measure designed to assess overall functioning in the context of new motherhood. Functional domains include social support, management, mother-child interaction, infant care, self-care, adjustment, and psychological well-being (of the mother). The BIMF demonstrates strong internal consistency. with Cronbach's alpha for the full 20-item scale between .83-.87 indicating strong inter-item agreement. A total score is generated from summing the 20 items (after the reverse-coding of items 16 and 18) and ranges from 0 to 120. Higher total scores are associated with greater levels of functioning.
Measured: Change between baseline and 12 months
Secondary outcomes (3)
Edinburgh Postnatal Depression Scale (EPDS)
(EPDS), a reliable, valid, and widely used scale that measures the presence and intensity of depressive symptoms. The scale has high internal consistency, test-retest reliability, and construct validity. Each answer is given a score of 0 to 3. The total scores are calculated with a maximum score of 30. Lower scores indicate lower presence or intensity.
Measured: Change between baseline and 12 months
State-Trait Anxiety Inventory (STAI)
The STAI has 20 items for assessing trait anxiety and 20 for state anxiety. Considerable evidence attests to the reliability and validity of the scale. Each type of anxiety has its own scale of 20 different questions that are scored. Scores range from 20 to 80, with higher scores correlating with greater anxiety.
Measured: Change between baseline and 12 months
Connor-Davidson Resilience Scale (CDRS)
The CDRS is a 25-item scale covering 17 resilience domains and used across languages, racial/ethnic, and cultural groups. It has been shown to have strong psychometric properties and has validated short forms. CDRS uses a scale of 0-4 with 0 being not true at all, to 4 being true nearly all the time.
Measured: Change between baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start15 Jan 2024
- Primary completion15 Oct 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maternal HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The investigators plan to conduct a 3-month, parallel-group, randomized controlled trial (RCT) to evaluate the effectiveness on improving maternal functioning.
- Masking
- None (open label)
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joyuus, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05876559
- Sponsor's protocol ID
- p-20167
- Other IDs
- R44MD014923
- Status last verified
- Apr 2025
- First submitted
- 16 May 2023
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marceau L, Matuk J, Barkin J, Pfeil D, Buterbaugh A, Perry DC, Soucie M, Bryant A. enDigital Postpartum Support for Early Risk Identification Among Postpartum Women: Formative Randomized Evaluation and Exploratory Predictive Modeling Study. JMIR Form Res. 2026 Jul 15;10:e89719. doi: 10.2196/89719.
PubMed 42456164
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Joyuus: A Web-based Tool for Postpartum Care Self-care to Address the Complex Needs of Underserved Women
- ClinicalTrials.gov ID
- NCT05876559
- Acronym / sponsor ID
- p-20167
- Conditions
- Maternal Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Joyuus, LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 25 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators plan to conduct a 3-month, parallel-group, randomized controlled trial (RCT) to evaluate the effectiveness on improving maternal functioning.
| Arm | Type | Receives |
|---|---|---|
| active intervention group | Experimental | Other: Joyuus Self-care Mobile AppParticipants will receive immediate access to Joyuus selfcare mobile app |
| standard care control group | Active comparator | Other: Standard CareParticipants will receive standard care, and will not have access to Joyuus selfcare mobile app until study completion. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Medical/health issues which would impact participants' health or ability to participate
- Did not have a live birth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Joyuus Self-care Mobile AppJoyuus 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. | Other | active intervention group |
| Standard CareStandard care is access to typical resources women have access to during postpartum and does not include the Joyuus intervention. | Other | standard care control group |
Primary outcome
Barkin Index of Maternal Functioning (BIMF)
Time frame: Change between baseline and 12 months
The BIMF is a 20-item self-report measure designed to assess overall functioning in the context of new motherhood. Functional domains include social support, management, mother-child interaction, infant care, self-care, adjustment, and psychological well-being (of the mother). The BIMF demonstrates strong internal consistency. with Cronbach's alpha for the full 20-item scale between .83-.87 indicating strong inter-item agreement. A total score is generated from summing the 20 items (after the reverse-coding of items 16 and 18) and ranges from 0 to 120. Higher total scores are associated with greater levels of functioning.
3 secondary outcomes
Edinburgh Postnatal Depression Scale (EPDS)
Time frame: Change between baseline and 12 months
State-Trait Anxiety Inventory (STAI)
Time frame: Change between baseline and 12 months
Connor-Davidson Resilience Scale (CDRS)
Time frame: Change between baseline and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Derived from this study: PubMed 42456164Marceau L, Matuk J, Barkin J, Pfeil D, Buterbaugh A, Perry DC, Soucie M, Bryant A. enDigital Postpartum Support for Early Risk Identification Among Postpartum Women: Formative Randomized Evaluation and Exploratory Predictive Modeling Study. JMIR Form Res. 2026 Jul 15;10:e89719. doi: 10.2196/89719.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Joyuus Self-care Mobile App in people with Maternal Health, run by Joyuus, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Barkin Index of Maternal Functioning (BIMF) (time frame: Change between baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05876559, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025; AzTrials last refreshed its copy on 30 Oct 2026.