Mindfulness for Cardiovascular Disease Risk

MR
Overseen ByMicheline R Anderson, PhD
Age: Any Age
Sex: Female
Trial Phase: Academic
Sponsor: Lifespan
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how mindfulness training during pregnancy might reduce the risk of cardiovascular disease (heart-related issues) for both mothers and their babies. Researchers aim to understand how mothers and infants respond to and recover from stress after mindfulness training and whether these responses relate to future heart health. The trial includes mothers who are six months postpartum and participated in a previous mindfulness study during pregnancy. Ideal candidates for this trial are mothers from the earlier study who had a single pregnancy and were at moderate to high risk for preeclampsia (a pregnancy complication characterized by high blood pressure).

As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve heart health for future generations.

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 might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that prenatal mindfulness training is safe for mothers and infants?

Research on mindfulness training, including during pregnancy, suggests it is generally safe. Although few studies have focused on side effects, no major safety problems have emerged. Mindfulness training can lower blood pressure in individuals with hypertension and has shown benefits for pregnant women at risk of high blood pressure issues. This indicates it is well-tolerated and safe to try.12345

Why are researchers excited about this trial?

Researchers are excited about prenatal mindfulness training for cardiovascular disease risk because it offers a holistic approach that traditional medical treatments, like medication or lifestyle changes, typically do not address. This treatment emphasizes mental and emotional well-being during pregnancy, potentially reducing stress-related factors that contribute to hypertensive disorders. Additionally, it strengthens the parent-child bond post-birth, which may have long-term benefits for both. By incorporating mindfulness, this approach could offer a unique, non-invasive complement to existing cardiovascular risk management strategies.

What evidence suggests that prenatal mindfulness training might be an effective treatment for cardiovascular disease risk?

Research has shown that mindfulness training during pregnancy can help lower blood pressure, particularly for those with slightly high or high levels. In this trial, participants who previously took part in a mindfulness arm or treatment as usual (TAU) during a prenatal mindfulness RCT will be assessed using the Still Face Paradigm. Studies suggest that mindfulness training helps manage stress and may prevent high blood pressure from returning in pregnant women. In past research, women at risk for pregnancy-related high blood pressure who participated in mindfulness training experienced better blood pressure and healthier baby growth. Participants also became more aware of their body and breathing, which helped them notice changes in blood pressure. These findings suggest that mindfulness training could reduce heart disease risk for both mothers and their children.12367

Are You a Good Fit for This Trial?

This trial is for mothers and infants who were part of a previous study on mindfulness during pregnancy. Participants must be over 18, speak English, not currently pregnant, and have been at 'moderate' to 'high' risk for preeclampsia but normotensive when they enrolled in the earlier study.

Inclusion Criteria

For the current research study: Participants will be individuals from the parent RCT who have consented to be contacted for future research in the parent study and are not pregnant during the mentored research study procedures

Exclusion Criteria

For the parent RCT study: active suicidality or psychosis
For the parent RCT study: multiple gestations
I have long-term high blood pressure.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prenatal Mindfulness Training

Participants undergo mindfulness training during pregnancy to prevent hypertensive disorders

Duration not specified

Postpartum Stress Reactivity Assessment

Maternal-infant physiological reactivity to stress is assessed using the Still Face Paradigm at 6 months postpartum

Single session
1 visit (in-person)

Follow-up

Maternal and infant cardiovascular risk is measured at 12 months postpartum

Single assessment
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Prenatal Mindfulness training
Trial Overview The trial examines how prenatal mindfulness training affects stress responses in mothers and their infants at 6 months postpartum. It also looks into whether these stress responses can predict cardiovascular disease risk one year after birth.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Follow-up to Mindfulness RCT Using Still Face ParadigmExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Lifespan

Lead Sponsor

Trials
43
Recruited
41,100+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials
315
Recruited
251,000+

Published Research Related to This Trial

A pilot study involving 48 women found that both a mindfulness intervention and a pregnancy support program effectively reduced perceived stress, with the mindfulness group showing greater improvement in present moment awareness.
Participants in the mindfulness program reported enhanced self-acceptance and stress management skills, suggesting that mindfulness may help women become less reliant on external support for their well-being.
Effects of mindfulness on maternal stress, depressive symptoms and awareness of present moment experience: A pilot randomised trial.Beattie, J., Hall, H., Biro, MA., et al.[2018]
A 12-month follow-up study involving 324 patients with heart disease showed that online mindfulness training led to a small but significant improvement in exercise capacity, with participants walking an average of 17.9 meters further in a 6-minute test compared to usual care.
Mindfulness training also resulted in favorable long-term effects on systolic blood pressure, mental functioning, and depressive symptoms, suggesting it could be a beneficial addition to standard clinical care for heart disease patients.
Online mindfulness as a promising method to improve exercise capacity in heart disease: 12-month follow-up of a randomized controlled trial.Gotink, RA., Younge, JO., Wery, MF., et al.[2019]
In a 21-day mindfulness-based intervention with 82 participants, 87% reported at least one momentary adverse effect during meditation, primarily anxiety, indicating that mindfulness practice can sometimes lead to temporary increases in anxiety.
Despite these momentary effects, 25% of participants experienced sustained adverse effects in daily life after the intervention, but these were not linked to the momentary effects during meditation, suggesting that increased awareness of internal states may contribute to these post-intervention challenges.
First, do no harm: An intensive experience sampling study of adverse effects to mindfulness training.Aizik-Reebs, A., Shoham, A., Bernstein, A.[2021]

Citations

Protocol for a randomized controlled trial comparing phone ...Mindfulness training (MT) is effective at reducing blood pressure in non-pregnant patients with pre-hypertension and hypertension and has proven more effective ...
NCT03679117 | Prenatal Mindfulness & Hypertension StudyMindfulness interventions hold great potential as a non-pharmacological approach to reduce stress and prevent the recurrence of hypertension in pregnant women ...
Mindfulness & Mechanisms Study | Clinical Research Trial ...The preliminary study of prenatal mindfulness training for women at risk for HDP demonstrated benefit on maternal blood pressure and fetal growth. However, the ...
Prenatal Mindfulness Training and Interoceptive ...Qualitative data corroborated these results; MT participants described improved awareness of body and breath sensations, ability to notice blood pressure ...
Mechanisms of mindfulness training to reduce maternal ...The goal of this ancillary study is to test the enduring effects of a prenatal mindfulness training intervention, conducted in the parent RCT, on postpartum ...
Prenatal Mindfulness Training and Interoceptive ...We sought to examine whether mindfulness training (MT) is associated with change in interoceptive awareness in pregnant people at risk for hypertension.
Mindfulness for Cardiovascular Disease RiskResearch on mindfulness training, including prenatal mindfulness, suggests it is generally safe for humans. While the study of adverse effects is limited, no ...
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