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Active, Not Recruiting

NCT Number: NCT06353113

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pregnancy Related Behavior Behavioral Symptoms Depression Discrimination, Racial Mental Health Issue Motor Activity Prejudice Racism Social Behavior Social Discrimination Stress

Age range

18 year–46 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

San Diego State University

San Diego, California, 92182, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Acceptability of the intervention

    Time frame: Post intervention (12 weeks)

    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.

  2. Demand of the intervention

    Time frame: Assessed across 12-week study period

    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).

  3. Retention

    Time frame: Assessed across 12-week study period

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

  4. Ease of recruitment

    Time frame: Assessed at enrollment

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

Secondary outcomes

  1. Discrimination

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

    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.

  2. Perceived stress

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

    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.

  3. Perinatal Depression

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

    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.

  4. Self-awareness

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

    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.

  5. Mindfulness

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

    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.

  6. Subjective physical activity

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

    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.

  7. Objective physical activity (steps)

    Time frame: Daily for 12 weeks

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

  8. Objective physical activity (intensity)

    Time frame: Daily for 12 weeks

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

  9. Cardiac health (heart rate)

    Time frame: Daily for 12 weeks

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

  10. Cardiac health (heart rate variability)

    Time frame: Daily for 12 weeks

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

  11. Cultural adaptations

    Time frame: Post-Intervention (12 weeks)

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

  12. Birth outcomes (gestational age)

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

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

  13. Birth outcomes (type of delivery)

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

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

  14. Birth outcomes (intervention used for delivery)

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

    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.

  15. Birth outcomes (birth weight)

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

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

  16. Birth outcomes (maternal weight)

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

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

  17. Birth outcomes (pregnancy-related disorders)

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

    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.)

Sponsors and collaborators

Lead sponsor

San Diego State University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 8, 2024
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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