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

NCT06353113 | Active Not Recruiting

• 1 other identifier: HS-2023-0254
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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:

• 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.

Conditions

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

Keywords

Feasibility; Yoga; Intervention; Mobile Application; Mindfulness; Physical Activity; Pregnant

Outcome Measures

Primary Outcomes (4)

• Acceptability of the intervention

  Assessed using an investigator-developed questionnaire using a 5 point likert scale from strongly agree to strongly disagree. Acceptability benchmark: \> 70% of participants report the intervention to be satisfactory, intend to continue using the app, and perceive the app content to be appropriate for pregnancy.

  Post intervention (12 weeks)

• Demand of the intervention

  Assessed by measuring actual use of the mobile app with data analytics provided from Down dog. Demand benchmark: \>70% of participants complete at least 75% of their weekly prescribed minutes (i.e., ≥ 45 of 60 minutes per week).

  Assessed across 12-week study period

• Retention

  Assessed by calculating the proportion of enrolled participants that complete intervention vs withdrawals. Retention benchmark: ≥70% (N=35) complete the intervention.

  Assessed across 12-week study period

• Ease of recruitment

  Assessed by evaluating enrollment rate. Recruitment benchmark: \>8 participants will be enrolled each month on average.

  Assessed at enrollment

Secondary Outcomes (17)

• Discrimination

  Baseline, Mid-intervention (6 weeks), and Post-intervention (12 weeks)

• Perceived stress

  Baseline, Mid-intervention (6 weeks), and Post-intervention (12 weeks)

• Perinatal Depression

  Baseline, Mid-intervention (6 weeks), and Post-intervention (12 weeks)

• Self-awareness

  Baseline, Mid-intervention (6 weeks), and Post-intervention (12 weeks)

• Mindfulness

  Baseline, Mid-intervention (6 weeks), and Post-intervention (12 weeks)

Study Arms (1)

Down Dog Prenatal Yoga App

EXPERIMENTAL

Prenatal yoga via Down Dog Prenatal Yoga Mobile App 20 minutes a day, 3 days per week, for 12 weeks.

Behavioral: Down Dog Prenatal Yoga App

Interventions

Down Dog Prenatal Yoga App BEHAVIORAL

The Down Dog prenatal yoga app launched in 2015 and was designed to align with the changes a pregnant body goes through in each trimester. Users can select a practice by trimester, which will offer modification cues to work with a changing body during pregnancy. Users can also customize their experience by boosting things like Heartburn or Pubic Symphysis so they can continue to practice yoga and omit poses that might be uncomfortable. The app also utilizes user feedback, to continuously implement new practices to better their app for user interface. All of the prenatal yoga classes were created by a certified and experienced prenatal yoga instructor who has a 200hr yoga certification through Pure Yoga (New York), 80hr prenatal yoga certification through Prenatal Yoga Center (New Yoga), and is Trauma Informed Yoga certified through Exhale to Inhale (New York).

Down Dog Prenatal Yoga App

Eligibility Criteria

• Age: 18 Years - 46 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• San Diego State University: lead

Study Sites (1)

San Diego State University

San Diego, California, 92182, United States

Location

Related Publications (11)

• 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.

  PMID: 34383557 BACKGROUND

• 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.

  PMID: 36190428 BACKGROUND

• 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.

  PMID: 23360946 BACKGROUND

• 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.

  PMID: 9699746 BACKGROUND

• 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.

  PMID: 17689648 BACKGROUND

• 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.

  PMID: 35327766 BACKGROUND

• 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.

  PMID: 19030445 BACKGROUND

• 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.

  PMID: 15865489 BACKGROUND

• 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.

  PMID: 33989862 BACKGROUND

• 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.

  PMID: 25747520 BACKGROUND

• 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.

  PMID: 35371532 BACKGROUND

MeSH Terms

Conditions

Racism; Depression; Motor Activity

Condition Hierarchy (Ancestors)

Prejudice; Social Behavior; Behavior; Social Discrimination; Behavioral Symptoms

Study Officials

• Jeni Green, PhD

  San Diego State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: April 8, 2024
• Study Start: April 18, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)