Feasibility of a Prenatal Yoga Mobile App in African American Pregnant Women

Depression Clinical Trial

Official title: Assessing the Feasibility of a Prenatal Mobile App in Pregnant African American Women: The Mindful Maternity Study

Status Recruiting

Clinical Trial Summary

The goal of this research is to test if a prenatal yoga app can improve well-being in African American/Black (AA) pregnant women. The main questions it aims to answer are:

1. Is the Down Dog prenatal yoga app feasible for AA pregnant women?

2. How does mental and physical health change after using the Down Dog app for 12-weeks?

3. What cultural adaptations to the Down Dog app are needed?

The study lasts for 12 weeks and participants are asked to:

• do prenatal yoga with the app for at least 20 min/day, three days/week, from home

• wear a Garmin Vivosmart 5 watch daily

• complete four online surveys

• complete an optional virtual interview

This project aims to advance public health by contributing to a broader understanding of how prenatal yoga can support the health and well-being of AA pregnant women and promote optimal maternal and child health outcomes.

Clinical Trial Description

Recruitment: The investigators will recruit 50 pregnant African American women from local prenatal clinics, non-profits, and social media.

Eligibility: All interested participants will complete a web-based eligibility screener (~5 minutes). Eligible participants will be asked to schedule a virtual intake appointment to review the consent form with a research team member.

Procedures: Participants must sign an informed consent and complete a Physical Activity Readiness Medical Examination (PARmed-X) for Pregnancy with their healthcare provider before beginning the study. Once participants sign the consent and return a completed PARmed-X form, they will be asked to schedule an in-person enrollment appointment.

During the in-person enrollment appointment, participants will receive a free yoga mat and Garmin Vivosmart 5, and study materials. A research team member will set up the Garmin device for the participant. Participants will be asked to resume normal activities for one week before beginning the intervention and to complete a baseline survey.

After one week of baseline data collection, a research team member will send the participant an email with instructions to download/use the prenatal yoga mobile app and other relevant study materials. Participants will then engage in prenatal yoga using the mobile app for at least 20 min/day, 3 days/week for the next 12 weeks. Participants will receive a mid-intervention survey at 6 weeks, a post-intervention survey at 12 weeks, and will have an opportunity to complete a virtual interview when the study is over. Within 1-2 weeks after the participants' due date, a research team member will send an online birth outcomes survey to collect self-reported birth outcomes.

The baseline, mid-intervention, and post-intervention surveys will ask about mental and physical health and perceptions about using the prenatal mobile app. The optional virtual interview will ask questions related to further understanding the feasibility of the prenatal yoga mobile app and exploring cultural adaptations to improve the app. ;

Related Conditions & MeSH terms

• Depression
• Discrimination, Racial
• Mental Health Issue
• Pregnancy Related
• Stress

• NCT number: NCT06353113
• Study type: Interventional
• Source: San Diego State University
• Contact: Jennifer Green, PhD
• Phone: 619-594-6489
• Email: jgreen5@sdsu.edu
• Status: Recruiting
• Phase: N/A
• Start date: July 2024
• Completion date: November 2024