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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness and Wearable Biosensors to Prevent Hypertensive Disorders of Pregnancy Study: MINDBP
- ClinicalTrials.gov ID
- NCT07218237
- Acronym / sponsor ID
- MINDBP / PRO00056473
- Conditions
- Preeclampsia
- Keywords
- Hypertensive disorders of pregnancy, Mindfulness, Biofeedback
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 20 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MT + Biofeedback | Experimental | Behavioral: Mindfulness training, Behavioral: Garmin Vivoactive 4 watchMindfulness training plus self-monitoring with access to data from wearable biosensor |
| MT | Experimental | Behavioral: Mindfulness trainingMindfulness training (no access to wearable biosensor data) |
| Control | No intervention | –Routine prenatal care alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness trainingMindfulness training with trained instructors | Behavioural | MT, MT + Biofeedback |
| Garmin Vivoactive 4 watchBiofeedback with a wearable biosensor that continuously monitors heart rate variability and generates stress scores. | Behavioural | MT + Biofeedback |
Primary outcome
Feasibility of multisite RCT
Time frame: 3 years
Assess study feasibility as measured by retention rate
5 secondary outcomes
Acceptability of MINDBP intervention
Time frame: Collected at the 3 study visits: 1 week, 1 month, and 2 months after completion of 8-week mindfulness training intervention.
Home blood pressure
Time frame: Daily blood pressure measurements for 6 weeks throughout the study
Heart rate variability
Time frame: Up to 34 weeks
Perceived stress
Time frame: Measured at baseline and 2, 3, and 4 months after consent.
Pregnancy-related anxiety
Time frame: Measured at baseline and 2, 3, and 4 months after consent.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna Palatnik, MD principal investigator
Medical College of Wisconsin
Margaret Bublitz, PhD principal investigator
Brown University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Palatnik, MD (14148056627, apalatnik@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of multisite RCT (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.