PreeclampsiaMINDBPNCT07218237
Mindfulness and Wearable Biosensors to Prevent Hypertensive Disorders of Pregnancy
A study testing Mindfulness training and Garmin Vivoactive 4 watch in people with Preeclampsia, run by Medical College of Wisconsin at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Mindfulness training and Garmin Vivoactive 4 watch
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2026to 1 Oct 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Anna Palatnik, MD, 414-805-6627, apalatnik@mcw.edu
Alyssa Hernandez, DO, 4149552781, alyhernandez@mcw.edu
- Recruiting
Brown University
Providence, Rhode Island, 02904
Margaret Bublitz, PhD, 401-793-7884, mbublitz@brownhealth.org
About this study
Official title: Mindfulness and Wearable Biosensors to Prevent Hypertensive Disorders of Pregnancy Study: MINDBP
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.
Read the detailed description
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. MT participants will receive 8 weekly phone-based MT sessions plus two booster sessions at 1 and 2 months post-intervention. All participants will wear Garmin Vivoactive 4 watches. Blood pressure, heart rate, heart rate variability, perceived stress, and pregnancy-related anxiety will be assessed at baseline (≤16 weeks), post-intervention (~24 weeks), and after each booster (~28 and 32 weeks). Feasibility, fidelity, and acceptability outcomes will be assessed after each post-intervention
- Conditions
- Preeclampsia
- Being tested
- Mindfulness training, Garmin Vivoactive 4 watch
- Keywords
- Hypertensive disorders of pregnancy, Mindfulness, Biofeedback
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness trainingBehavioural
Mindfulness training with trained instructors
Garmin Vivoactive 4 watchBehavioural
Biofeedback with a wearable biosensor that continuously monitors heart rate variability and generates stress scores.
| Study group | Role | What they receive |
|---|---|---|
| MT + Biofeedback | Experimental | Mindfulness training plus self-monitoring with access to data from wearable biosensor Receives: Behavioral: Mindfulness training; Behavioral: Garmin Vivoactive 4 watch |
| MT | Experimental | Mindfulness training (no access to wearable biosensor data) Receives: Behavioral: Mindfulness training |
| Control | No intervention | Routine prenatal care alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of multisite RCT
Assess study feasibility as measured by retention rate
Measured: 3 years
Secondary outcomes (5)
Acceptability of MINDBP intervention
Assess intervention acceptability using Theoretical Framework of Acceptability Questionns (TFAQ). The TFAQ include 8 Likert-scale items which are averaged to provide an overall score from 1-5, with 5 indicating higher acceptability.
Measured: Collected at the 3 study visits: 1 week, 1 month, and 2 months after completion of 8-week mindfulness training intervention.
Home blood pressure
Average systolic and diastolic blood pressure measured using home blood pressure monitoring
Measured: Daily blood pressure measurements for 6 weeks throughout the study
Heart rate variability
Average daily stress score based on heart rate variability from biosensor watch
Measured: Up to 34 weeks
Perceived stress
Self-reported perceived stress using the Perceived Stress Scale, which is scored from 0-40, with higher scores indicating higher perceived stress.
Measured: Measured at baseline and 2, 3, and 4 months after consent.
Pregnancy-related anxiety
Self-reported pregnancy-related anxiety using the PRAQ-R2, which is cored from 0-40, with higher scores indicating higher anxiety.
Measured: Measured at baseline and 2, 3, and 4 months after consent.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2025
- Study start1 Apr 2026
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Palatnik, MD, Medical College of Wisconsin
- Investigators
- Anna Palatnik, MD, Principal investigator, Medical College of WisconsinMargaret Bublitz, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07218237
- Sponsor's protocol ID
- PRO00056473
- Acronym
- MINDBP
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data collected in the study will include information collected from participants during pregnancy and up to 6 weeks postpartum. Variables will include demographic information, participant-reported survey data, wearable biosensor data, and maternal blood pressure from n=90 participants. All data will be de-identified prior to data sharing.