Clinical trial NCT06353113: Feasibility of a Prenatal Yoga Mobile App in African American Pregnant Women
Official title: Assessing the Feasibility of a Prenatal Mobile App in Pregnant African American Women: The Mindful Maternity Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy Related
Mental Health Issue
Discrimination, Racial
Stress
Depression
Keywords: Feasibility
Yoga
Intervention
Mobile Application
Mindfulness
Physical Activity
Pregnant
Lead sponsor: San Diego State University
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

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 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.

Eligibility criteria: Inclusion Criteria

Participants will be included in the study if they:

* Are 18-46 years of age (childbearing age)
* Reside in San Diego Metropolitan Area
* Speak English
* Are between 13-28 weeks when intervention starts
* Are primiparous (giving birth for the first time)
* Have a singleton pregnancy (pregnant with only one baby)
* Are yoga naive (\<60 min/month for past 6 months)
* Have access to smartphone/mobile device
* Willing to wear a wrist worn fitness tracker for the duration of the study
* Willing to download and use 3 mobile apps for the duration of the study
* Identify as Black or African American
* Return a completed Physical Activity Readiness Medical Examination (PARmed-X) for Pregnancy form (HCP approves participation in prenatal PA program before beginning intervention)

Exclusion Criteria:

* High-risk pregnancy
* Severe psychiatric disorder or substance abuse
* Denial of physical activity participation from physician

Primary outcomes:
measure: Acceptability of the intervention
timeFrame: Post intervention (12 weeks)
measure: Demand of the intervention
timeFrame: Assessed across 12-week study period
measure: Retention
timeFrame: Assessed across 12-week study period
measure: Ease of recruitment
timeFrame: Assessed at enrollment
Secondary outcomes:
measure: Discrimination
timeFrame: Baseline, Mid-intervention (6 weeks), and Post-intervention (12 weeks)
measure: Perceived stress
timeFrame: Baseline, Mid-intervention (6 weeks), and Post-intervention (12 weeks)
measure: Perinatal Depression
timeFrame: Baseline, Mid-intervention (6 weeks), and Post-intervention (12 weeks)
measure: Self-awareness
timeFrame: Baseline, Mid-intervention (6 weeks), and Post-intervention (12 weeks)
measure: Mindfulness
timeFrame: Baseline, Mid-intervention (6 weeks), and Post-intervention (12 weeks)
measure: Subjective physical activity
timeFrame: Baseline, Mid-intervention (6 weeks), and Post-intervention (12 weeks)
measure: Objective physical activity (steps)
timeFrame: Daily for 12 weeks
measure: Objective physical activity (intensity)
timeFrame: Daily for 12 weeks
measure: Cardiac health (heart rate)
timeFrame: Daily for 12 weeks
measure: Cardiac health (heart rate variability)
timeFrame: Daily for 12 weeks
measure: Cultural adaptations
timeFrame: Post-Intervention (12 weeks)
measure: Birth outcomes (gestational age)
timeFrame: Post-delivery (~2 weeks after delivery of baby)
measure: Birth outcomes (type of delivery)
timeFrame: Post-delivery (~2 weeks after delivery of baby)
measure: Birth outcomes (intervention used for delivery)
timeFrame: Post-delivery (~2 weeks after delivery of baby)
measure: Birth outcomes (birth weight)
timeFrame: Post-delivery (~2 weeks after delivery of baby)
measure: Birth outcomes (maternal weight)
timeFrame: Post-delivery (~2 weeks after delivery of baby)
measure: Birth outcomes (pregnancy-related disorders)
timeFrame: Post-delivery (~2 weeks after delivery of baby)
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego State University
state: California
Study officials:
affiliation: San Diego State University
name: Jeni Green, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: MacDorman MF, Thoma M, Declcerq E, Howell EA. Racial and Ethnic Disparities in Maternal Mortality in the United States Using Enhanced Vital Records, 2016-2017. Am J Public Health. 2021 Sep;111(9):1673-1681. doi: 10.2105/AJPH.2021.306375. Epub 2021 Aug 12.
citation: Ely DM, Driscoll AK. Infant Mortality in the United States, 2020: Data From the Period Linked Birth/Infant Death File. Natl Vital Stat Rep. 2022 Sep;71(5):1-18.
citation: Giurgescu C, Kavanaugh K, Norr KF, Dancy BL, Twigg N, McFarlin BL, Engeland CG, Hennessy MD, White-Traut RC. Stressors, resources, and stress responses in pregnant African American women: a mixed-methods pilot study. J Perinat Neonatal Nurs. 2013 Jan-Mar;27(1):81-96. doi: 10.1097/JPN.0b013e31828363c3.
citation: Knuist M, Bonsel GJ, Zondervan HA, Treffers PE. Risk factors for preeclampsia in nulliparous women in distinct ethnic groups: a prospective cohort study. Obstet Gynecol. 1998 Aug;92(2):174-8. doi: 10.1016/s0029-7844(98)00143-4.
citation: Brown HL, Chireau MV, Jallah Y, Howard D. The "Hispanic paradox": an investigation of racial disparity in pregnancy outcomes at a tertiary care medical center. Am J Obstet Gynecol. 2007 Aug;197(2):197.e1-7; discussion 197.e7-9. doi: 10.1016/j.ajog.2007.04.036.
citation: Dagher RK, Linares DE. A Critical Review on the Complex Interplay between Social Determinants of Health and Maternal and Infant Mortality. Children (Basel). 2022 Mar 10;9(3):394. doi: 10.3390/children9030394.
citation: Larson CP. Poverty during pregnancy: Its effects on child health outcomes. Paediatr Child Health. 2007 Oct;12(8):673-7. doi: 10.1093/pch/12.8.673.
citation: Narendran S, Nagarathna R, Narendran V, Gunasheela S, Nagendra HR. Efficacy of yoga on pregnancy outcome. J Altern Complement Med. 2005 Apr;11(2):237-44. doi: 10.1089/acm.2005.11.237.
citation: Green J, James D, Larkey L, Leiferman J, Buman M, Oh C, Huberty J. A qualitative investigation of a prenatal yoga intervention to prevent excessive gestational weight gain: A thematic analysis of interviews. Complement Ther Clin Pract. 2021 Aug;44:101414. doi: 10.1016/j.ctcp.2021.101414. Epub 2021 May 6.
citation: Battle CL, Uebelacker LA, Magee SR, Sutton KA, Miller IW. Potential for prenatal yoga to serve as an intervention to treat depression during pregnancy. Womens Health Issues. 2015 Mar-Apr;25(2):134-41. doi: 10.1016/j.whi.2014.12.003.
citation: Green J, Neher T, Puzia M, Laird B, Huberty J. Pregnant women's use of a consumer-based meditation mobile app: A descriptive study. Digit Health. 2022 Mar 27;8:20552076221089098. doi: 10.1177/20552076221089098. eCollection 2022 Jan-Dec.