ClinicalTrials.gg
Active, not recruitingNCT06353113Updated Nov 10, 2026

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

An interventional study of Down Dog Prenatal Yoga App in Pregnancy Related, Mental Health Issue and Discrimination, Racial, sponsored by San Diego State University. Active, not recruiting at 1 site in United States. Open to female participants aged 18 Years to 46 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by San Diego State University · Not applicable, Interventional, and Other

Updated Nov 10, 2026Primary completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 46 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • Feasibility
  • Yoga
  • Intervention
  • Mobile Application
  • Mindfulness
  • Physical Activity
  • Pregnant
03

In context

Racism

47 studies on the registry are indexed under Racism; 8 are open to participants now.

This study's planned enrollment of 50 is below the median of 106 across 34 interventional studies indexed under Racism.

Browse Racism studies →

Lead sponsor

San Diego State University is the lead sponsor of 149 studies on the registry; 43 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 46 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • High-risk pregnancy
  • Severe psychiatric disorder or substance abuse
  • Denial of physical activity participation from physician
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Down Dog Prenatal Yoga App

    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

  • BehavioralDown Dog Prenatal Yoga App

    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).

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Post intervention (12 weeks)

  2. 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).

    Time frame: Assessed across 12-week study period

  3. Retention

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

    Time frame: Assessed across 12-week study period

  4. Ease of recruitment

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

    Time frame: Assessed at enrollment

Secondary outcomes

  1. Discrimination

    Discrimination will be assessed using the Discrimination in Medical Settings (DMS) Scale. The DMS is a 7-item instrument scored on a 5-point Likert scale (1-never, 2-rarely, 3-sometimes, 4-most of the time, 5-always). Higher scores indicate greater levels of discrimination.

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

  2. Perceived stress

    Perceived stress will be measured using the Perceived Stress Scale (PSS-10). The PSS-10 is a 10-item instrument scored on a 5-point Likert scale (0-Never, 1- Almost Never, 2- Sometimes, 3- Fairly Often, 4-Very Often). Higher scores indicate greater levels of perceived stress.

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

  3. Perinatal Depression

    Perinatal Depression will be measured using the 10-item Edinburg Postnatal Depression Scale (EPDS). Scores range from 0-30, with "possible depression" defined by a score of 10 or greater.

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

  4. Self-awareness

    Self-awareness will be measured using the Self Awareness Outcomes Questionnaire (SAOQ). The SAOQ is a 38-item instrument scored on a 5-point Likert scale (1- Never, 2- Rarely, 3- Occasionally, 4- Frequently, 5- Almost Always). The SAOQ has 4 subscales and the score is determined by calculating the mean of certain items corresponding to each subscale. Higher scores indicate greater frequency of experienced outcomes.

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

  5. Mindfulness

    Mindfulness will be measured using the Mindful Attention Awareness Scale (MAAS). The MAAS is a 15-item instrument scored on a 6-point Likert scale (1- Almost Always, 2- Very Frequently, 3- Somewhat Frequently, 4- Somewhat Infrequently, 5- Very Infrequently, 6- Almost Never). Higher scores indicate greater levels of mindfulness.

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

  6. Subjective physical activity

    Subjective physical activity will be measured using the Pregnancy Physical Activity Questionnaire (PPAQ). The instrument assesses the approximate amount of time spent in 32 activities including household/caregiving, occupational, sports/exercise, and inactivity during the current trimester. Duration and intensity will be determined using Compendium-based MET values.

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

  7. Objective physical activity (steps)

    The number of steps per day will be measured using the Garmin Vivosmart 5 fitness tracker.

    Time frame: Daily for 12 weeks

  8. Objective physical activity (intensity)

    Intensity of activity will be measured using metabolic equivalents (METs) value via the Garmin Vivosmart 5 fitness tracker.

    Time frame: Daily for 12 weeks

  9. Cardiac health (heart rate)

    Heart rate in beats per minute (BPM) will be measured using the Garmin Vivosmart 5 fitness tracker.

    Time frame: Daily for 12 weeks

  10. Cardiac health (heart rate variability)

    Heart rate variability in milliseconds will be measured using the Garmin Vivosmart 5 fitness tracker.

    Time frame: Daily for 12 weeks

  11. Cultural adaptations

    Qualitative interviews will be used to explore and identify cultural adaptations relevant for African American pregnant women.

    Time frame: Post-Intervention (12 weeks)

  12. Birth outcomes (gestational age)

    Self-report survey will be used to assess gestational age (total length of pregnancy in weeks).

    Time frame: Post-delivery (~2 weeks after delivery of baby)

  13. Birth outcomes (type of delivery)

    Self-report survey will be used to assess the type of delivery (e.g., vaginal, planned C-section, unplanned C-section).

    Time frame: Post-delivery (~2 weeks after delivery of baby)

  14. Birth outcomes (intervention used for delivery)

    Self-report survey will be used to assess interventions used for delivery, if applicable, using a list. An intervention can include use of medical treatments or procedures to induce labor or assist with delivery.

    Time frame: Post-delivery (~2 weeks after delivery of baby)

  15. Birth outcomes (birth weight)

    Self-report survey will be used to assess birth weight (weight of baby in pounds + ounces).

    Time frame: Post-delivery (~2 weeks after delivery of baby)

  16. Birth outcomes (maternal weight)

    Self-report survey will be used to assess maternal weight (last known weight before delivery in pounds).

    Time frame: Post-delivery (~2 weeks after delivery of baby)

  17. Birth outcomes (pregnancy-related disorders)

    Self-report survey will be used to assess pregnancy-related disorders, if applicable, using a list. Pregnancy-related disorders could be complications including physical and mental conditions that affect the health of the pregnant or postpartum person, their baby, or both (e.g.,preterm birth, gestational diabetes, preeclampsia, eclampsia, birth injury, postpartum hemorrhage, postpartum hypertension etc.)

    Time frame: Post-delivery (~2 weeks after delivery of baby)

07

Study locations

1 site
08

References and documents

Publications

  • 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. PubMed 34383557 ↗
  • 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. PubMed 36190428 ↗
  • 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. PubMed 23360946 ↗
  • 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. PubMed 9699746 ↗
  • 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. PubMed 17689648 ↗
  • 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. PubMed 35327766 ↗
  • 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. PubMed 19030445 ↗
  • 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. PubMed 15865489 ↗
  • 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. PubMed 33989862 ↗
  • 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. PubMed 25747520 ↗
  • 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. PubMed 35371532 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2025 to primary completion in Jul 2026, 15 months.

Of 29 non-industry interventional studies with no phase under Racism, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 41. This study's 15 months is below that.

Counting every sponsor, half of 29 studies reached it within 32 months; a quarter within 14 and three quarters within 41.

Primary completion moved once since we started tracking on Sep 25, 2026: Aug 2026 → Jul 2026, on Nov 10, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Mar 4, 2024
First posted
Apr 8, 2024
StartActual
Apr 18, 2025
Primary completionActual
Jul 20, 2026was Aug 2026
CompletionEst.
Dec 2026
Last update
Nov 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
Aug 2026→Jul 20, 2026 (actual)
Nov 10, 2026
Show all 1 update
  1. Nov 10, 2026
    Primary completion Aug 2026→Jul 20, 2026 (now actual)
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06353113
Responsible party
Jennifer Green (Assistant Professor, San Diego State University) — Principal investigator
First posted
Apr 8, 2024
Start date
Apr 18, 2025
Primary completion
Jul 20, 2026
Completion
Dec 2026 (estimated)
Last update
Nov 10, 2026

Study contacts

Jeni Green, PhD
principal investigator · San Diego State University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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