Prenatal Yoga App for Pregnancy

Overseen By Jeni Green, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: San Diego State University

Disqualifiers: High-risk pregnancy, Severe psychiatric disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 12 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a prenatal yoga app to determine its impact on the well-being of pregnant African American/Black women. Participants will use the Down Dog Prenatal Yoga App for 20 minutes of home yoga, three days a week, over 12 weeks. The study examines the app's effects on mental and physical health and considers necessary cultural adaptations. Ideal candidates are first-time mothers, pregnant with one baby, between 13-28 weeks, residing in San Diego, and new to yoga. Participants must also wear a fitness tracker, complete surveys, and have smartphone access.

As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance prenatal care for African American/Black women.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with your doctor before participating.

What prior data suggests that the Down Dog Prenatal Yoga App is safe for AA pregnant women?

Research has shown that prenatal yoga, such as the kind offered through the Down Dog app, is generally safe for pregnant women. Studies have found no harmful effects from prenatal yoga, even for those with high-risk pregnancies. The app provides a new, personalized yoga session each time, keeping the routine engaging. As the Down Dog Prenatal Yoga App is neither a medication nor a medical procedure, it is considered low-risk. Participants can follow yoga sessions from home, making it a safe option for expecting mothers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Down Dog Prenatal Yoga App because it offers a convenient and accessible way for pregnant individuals to engage in prenatal yoga, which isn't typically available with standard prenatal exercise programs. Unlike traditional in-person yoga classes, this app allows users to practice at home, requiring just 20 minutes a day, three times a week. The app's flexibility and ease of use make it a promising option for improving pregnancy outcomes, such as reducing stress and enhancing physical comfort, without the need to attend scheduled classes.

What evidence suggests that the Down Dog Prenatal Yoga App is effective for improving well-being in African American pregnant women?

Research has shown that prenatal yoga can improve quality of life and reduce stress, anxiety, and depression in pregnant women. It can also help manage pain during labor. In this trial, participants will use the Down Dog Prenatal Yoga App, which offers yoga sessions tailored to individual needs, potentially enhancing engagement and effectiveness. Many pregnant women already use apps for pregnancy information, so they might find app-based yoga easy to use. These factors suggest that the Down Dog app could positively impact mental and physical health during pregnancy. ^{1 2 3 4 5}

Who Is on the Research Team?

Jeni Green, PhD

Principal Investigator

San Diego State University

Are You a Good Fit for This Trial?

This trial is for African American pregnant women who are interested in using a prenatal yoga app to potentially improve their well-being. Participants should be willing to practice yoga at home for at least 20 minutes per day, three times a week, wear a fitness watch daily, and complete online surveys.

Inclusion Criteria

Reside in San Diego Metropolitan Area

Are between 13-28 weeks when intervention starts

Are primiparous (giving birth for the first time)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 virtual visit

Baseline

Participants resume normal activities for one week and complete a baseline survey

1 week

1 in-person visit

Treatment

Participants engage in prenatal yoga using the mobile app for at least 20 min/day, 3 days/week for 12 weeks

12 weeks

4 online surveys, optional virtual interview

Follow-up

Participants complete a birth outcomes survey within 1-2 weeks after delivery

2 weeks

1 online survey

What Are the Treatments Tested in This Trial?

Interventions

• Down Dog Prenatal Yoga App

Trial Overview The study is testing the feasibility of the Down Dog Prenatal Yoga App over a period of 12 weeks. It will evaluate how this app affects mental and physical health in participants and what cultural adjustments might be necessary for optimal use by African American pregnant women.

How Is the Trial Designed?

Group I: Down Dog Prenatal Yoga App Experimental Treatment 1 Intervention

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

Down Dog Prenatal Yoga App is already approved in United States, European Union for the following indications:

Approved in United States as Down Dog Prenatal Yoga App for:

• Prenatal wellness
• Maternal health support

Approved in European Union as Down Dog Prenatal Yoga App for:

• Prenatal wellness
• Maternal health support

Who Is Running the Clinical Trial?

San Diego State University

Lead Sponsor

Trials

182

Recruited

119,000+

Published Research Related to This Trial

Pregnant women reported that practicing yoga helped manage various pregnancy-related symptoms, such as insomnia and back pain, while also enhancing their emotional connection to their unborn child and fostering positive beliefs about childbirth.

Participants expressed a desire for healthcare professionals to encourage yoga practice during pregnancy and suggested that integrating pregnancy yoga into antenatal education could improve participation and benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences of Pregnant Women Participating in Antenatal Yoga: A Qualitative Study. Höbek Akarsu, R., Kocak, DY., Akarsu, GD.[2022]

This systematic review aims to evaluate the clinical effectiveness of pregnancy yoga by analyzing various studies, focusing on outcomes like quality of life, stress, anxiety, and pain management during labor.

The review will categorize studies based on their effectiveness and will use rigorous methods, including the Cochrane Risk of Bias Assessment and GRADE criteria, to ensure high-quality evidence is provided for clinicians and health policymakers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness and characteristics of pregnancy yoga interventions: a systematic review protocol. Corrigan, L., Eustace-Cook, J., Moran, P., et al.[2020]

A study involving 19 healthy pregnant women in their third trimester showed that moderate-intensity yoga significantly increased maternal heart rates during the session, but did not negatively affect fetal heart rates, indicating safety for both mother and baby.

Uterine activity was notably higher during the yoga session compared to rest, meditation, and recovery periods, suggesting that prenatal yoga can be beneficial in promoting uterine engagement without adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fetal and maternal responses to yoga in the third trimester. Gavin, NR., Kogutt, BK., Fletcher, W., et al.[2021]

Pregnancy yoga interventions significantly reduce anxiety, depression, and perceived stress in pregnant women, based on a meta-analysis of 29 studies involving 2217 participants.

Yoga also contributes to shorter labor duration and increases the likelihood of normal vaginal births, particularly when practiced in 12 or more sessions of over 60 minutes each.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The characteristics and effectiveness of pregnancy yoga interventions: a systematic review and meta-analysis. Corrigan, L., Moran, P., McGrath, N., et al.[2022]

A systematic review of randomized controlled trials found that interventions like yoga, exercise, music, and massage have low to very low evidence for reducing prenatal depression, indicating a need for more robust studies.

Among the interventions, music therapy, particularly Chinese Medicine Five Element Music, showed the most promise, while integrated yoga was more effective than simple yoga in improving prenatal depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of music, massage, yoga and exercise on antenatal depression: A meta-analysis. Zhu, Y., Wang, R., Tang, X., et al.[2021]

Prenatal yoga, which combines physical postures, breath control, and meditation, may offer a more holistic approach to preventing excessive gestational weight gain (GWG) compared to physical activity alone, but current evidence is insufficient to confirm its effectiveness.

The review highlights a need for more research to explore the behavioral, psychological, and physical mechanisms of prenatal yoga in pregnant women, as existing studies have not definitively linked these factors to improved weight outcomes during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prenatal yoga and excessive gestational weight gain: A review of evidence and potential mechanisms. Green, J., Larkey, L., Leiferman, JA., et al.[2022]

In a survey of 100 high-risk pregnant women, those with prior yoga experience were significantly more likely to believe that yoga is safe during pregnancy, with an odds ratio of 5.9, indicating a strong association between experience and perceived safety.

The study found that 56% of participants expressed interest in attending prenatal yoga classes, and previous yoga experience was the only significant predictor of willingness to participate, suggesting that education about yoga's benefits may help increase participation among those without prior experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knowledge and Attitudes Toward Prenatal Yoga Among Women with High-Risk Pregnancies. Deshmukh, S., Seely, EW., Brickley, T., et al.[2020]

Prenatal yoga has been shown to provide significant benefits for women experiencing anxiety, depression, stress, low back pain, and sleep disturbances during pregnancy.

Research indicates that yoga is safe for first-time practitioners during pregnancy and is well-tolerated by the fetus, with some studies suggesting improved outcomes in high-risk pregnancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yoga in Pregnancy. Babbar, S., Shyken, J.[2022]

Citations

1. prenatal.downdogapp.com prenatal.downdogapp.com/

Prenatal Yoga | Down Dog Yoga. Select your time, level, focus, voice, and music, and Down Dog creates a unique, personalized yoga practice every time.

2. withpower.com withpower.com/trial/phase-depression-3-2024-a646d

Prenatal Yoga App for Pregnancy Research shows that prenatal yoga can improve quality of life, reduce stress, anxiety, and depression, and help with pain management during labor. These ...

3. play.google.com play.google.com/store/apps/details?id=com.downdogapp.prenatal&hl=en_US

Prenatal Yoga | Down Dog - Apps on Google Play With Prenatal Yoga you get a brand new prenatal yoga practice every time you come to your mat. Unlike following pre-recorded videos.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8136604/

An Assessment of Mobile Applications Designed to ... A recent study found that 55% of pregnant women were using an app related to pregnancy, birth, and/or childcare (12, 25). In fact, 7% of all existing mobile ...

5. apps.apple.com apps.apple.com/us/app/prenatal-yoga-down-dog/id1504152442

Prenatal Yoga | Down Dog - App Store - Apple A brand new prenatal yoga practice every time you come to your mat. Unlike following pre-recorded videos, Prenatal Yoga won't make you do the same yoga routine ...