Joyuus App for Postpartum Care

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Joyuus, LLC

Disqualifiers: Health issues, No live birth

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

137 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for women aged 18 or older who are within 0-6 months postpartum, have a smartphone with internet, and can speak, read, and write in English. It's not for those with health issues affecting their participation or who didn't have a live birth.

Inclusion Criteria

I gave birth within the last 6 months.

Must have a smartphone with internet access and are willing to use this device to participate in all study activities

Must be able to speak, read, and write in English

Exclusion Criteria

I don't have health issues that would affect my participation.

Did not have a live birth

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Needs Assessment

Conduct a needs assessment to understand informational, cultural, and language wants and needs in the Latina population

4 weeks

Tool Development

Complete the development of a fully interactive Joyuus web-based mobile tool in English and Spanish

8 weeks

Randomized Controlled Trial

Test the effectiveness of Joyuus with a diverse national sample of postpartum women

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• Joyuus Self-care Mobile App
• Standard Care

Trial Overview The study compares the Joyuus self-care mobile app to standard care in improving maternal functioning after childbirth. It checks if the app helps more with mood, resilience, support, and knowledge over follow-ups at 3-, 6-, and 12-weeks.

Participant Groups

Group I: active intervention group Experimental Treatment 1 Intervention

Participants will receive immediate access to Joyuus selfcare mobile app

Group II: standard care control group Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Joyuus, LLC

Lead Sponsor

Trials

1

Recruited

130+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+