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Mindfulness and Wearable Biosensors to Prevent Hypertensive Disorders of Pregnancy

Mindfulness and Wearable Biosensors to Prevent Hypertensive Disorders of Pregnancy Study: MINDBP

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Wearing a device

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The MINDBP study will enroll 90 pregnant women at risk for HDP across two sites (MCW and Brown) and randomize them to: (1) mindfulness training (MT) plus wearable biosensors, (2) MT alone, or (3) routine prenatal care."
  • "The MINDBP study will enroll 90 pregnant women at risk for HDP across two sites (MCW and Brown) and randomize them to: (1) MT + wearable biosensors, (2) MT alone, or (3) routine prenatal care."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

The MINDBP study is for pregnant women at risk for high blood pressure problems during pregnancy. It compares mindfulness training, with or without wearable body sensors, with routine pregnancy care. The main goal is to see if the study can be carried out.

The MINDBP study will enroll 90 pregnant women at risk for HDP across two sites (MCW and Brown) and randomize them to: (1) mindfulness training (MT) plus wearable biosensors, (2) MT alone, or (3) routine prenatal care. MT participants will receive 8 weekly phone-based MT sessions plus two booster sessions at 1 and 2 months post-intervention. The primary outcome is study feasibility.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be no more than 16 weeks pregnant.
  • Have a living baby in the womb with no known birth defects.
  • Have normal blood pressure when joining.
  • Have a moderate to high risk of preeclampsia, a pregnancy condition involving high blood pressure, under medical guidelines for low-dose aspirin use.

Who can't join

  • Be pregnant with more than one baby.
  • Have high blood pressure that started before pregnancy.
  • Be unable or unwilling to give informed consent, meaning agreement after learning about the study.
  • Have current suicidal thoughts or behavior, or psychosis, which means losing touch with reality.
  • Already practice yoga, meditation, mindfulness, or a similar activity at least once a week.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Pregnant patients at gestational age \<= 16 weeks * Live, non-anomalous gestation * Normotensive at enrollment * Meet criteria consistent with 'moderate' to 'high' risk for preeclampsia based on ACOG/USPSTF guidelines for low-dose aspirin administration to prevent hypertensive disorders of pregnancy Exclusion Criteria: * Multiple gestation * Chronic (pregestational hypertension) * Inability of unwillingness to provide informed consent * Active suicidality or psychosis * Ongoing mind-body practice (e.g., yoga, meditation, mindfulness \>= once per week)

Study sites (2)

RI

WI