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Pregnancy RelatedNCT06353113

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

A study testing Down Dog Prenatal Yoga App in people with Pregnancy Related and Mental Health Issue, run by San Diego State University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 46 years, women onlyHealthy volunteers can take part
What is being tested?
Down Dog Prenatal Yoga App
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
18 Apr 2025to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 46 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)
Show all 13Show fewer
  • 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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • San Diego State University

    San Diego, California, 92182

Other trials in United States

About this study

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

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?
Read more

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.

Being tested
Down Dog Prenatal Yoga App
Keywords
Feasibility, Yoga, Intervention, Mobile Application, Mindfulness, Physical Activity, Pregnant
Medical subject headings
Racism, Depression, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Down Dog Prenatal Yoga AppBehavioural

    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).

Study groups in NCT06353113
Study groupRoleWhat they receive
Down Dog Prenatal Yoga AppExperimentalPrenatal yoga via Down Dog Prenatal Yoga Mobile App 20 minutes a day, 3 days per week, for 12 weeks.
Receives: Behavioral: Down Dog Prenatal Yoga App

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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).

    Measured: 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.

    Measured: 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.

    Measured: Assessed at enrollment

Secondary outcomes (17)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Daily for 12 weeks

  11. Cultural adaptations

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

    Measured: 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).

    Measured: 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).

    Measured: 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.

    Measured: 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).

    Measured: 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).

    Measured: 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.)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2024
  2. Study start18 Apr 2025
  3. Primary completionAug 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06353113
Sponsor's protocol ID
HS-2023-0254
Status last verified
Apr 2026
First submitted
4 Mar 2024
Last updated
5 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Down Dog Prenatal Yoga App in people with Pregnancy Related and Mental Health Issue, run by San Diego State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability of the intervention (time frame: Post intervention (12 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06353113, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.

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