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

Trial Summary

What data supports the effectiveness of the treatment Down Dog 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 benefits suggest that using a prenatal yoga app like Down Dog could be effective for pregnant women. ^{1 2 3}

Is prenatal yoga safe for pregnant women?

Research suggests that prenatal yoga is generally safe for pregnant women, including those with high-risk pregnancies. Studies have shown no harmful effects on fetal or maternal heart rates during typical prenatal yoga sessions, and it is recommended for low-risk pregnancies. ^{1 2 3 4 5}

How is the Down Dog Prenatal Yoga App treatment different from other pregnancy yoga treatments?

The Down Dog Prenatal Yoga App offers a unique approach by providing a digital, app-based platform for prenatal yoga, allowing pregnant women to practice yoga conveniently at home, which may not be available with traditional in-person classes. This app-based format can offer personalized yoga sessions tailored to individual needs and schedules, making it more accessible and flexible compared to standard pregnancy yoga classes. ^{1 2 6 7 8}

What is the purpose of this trial?

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.

Research Team

Jeni Green, PhD

Principal Investigator

San Diego State University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

The characteristics and effectiveness of pregnancy yoga interventions: a systematic review and meta-analysis. [2022]

2. Ireland pubmed.ncbi.nlm.nih.gov

The effectiveness and characteristics of pregnancy yoga interventions: a systematic review protocol. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Knowledge and Attitudes Toward Prenatal Yoga Among Women with High-Risk Pregnancies. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Fetal and maternal responses to yoga in the third trimester. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Yoga in Pregnancy. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Experiences of Pregnant Women Participating in Antenatal Yoga: A Qualitative Study. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

The effect of music, massage, yoga and exercise on antenatal depression: A meta-analysis. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Prenatal yoga and excessive gestational weight gain: A review of evidence and potential mechanisms. [2022]