Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06353113
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-03-04
Brief Title:
Feasibility of a Prenatal Yoga Mobile App in African American Pregnant Women
Sponsor:
San Diego State University
Organization:
San Diego State University
Study Overview
Official Title:
Assessing the Feasibility of a Prenatal Mobile App in Pregnant African American Women The Mindful Maternity Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this research is to test if a prenatal yoga app can improve well-being in African AmericanBlack 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 minday three daysweek 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
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 minday three daysweek 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
Detailed 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 downloaduse 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 minday 3 daysweek 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
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 downloaduse 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 minday 3 daysweek 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None