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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MT + Biofeedback | Experimental | Mindfulness training plus self-monitoring with access to data from wearable biosensor |
|
| MT | Experimental | Mindfulness training (no access to wearable biosensor data) |
|
| Control | No Intervention | Routine prenatal care alone |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness training | Behavioral | Mindfulness training with trained instructors |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of multisite RCT | Assess study feasibility as measured by retention rate | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Collected at the 3 study visits: 1 week, 1 month, and 2 months after completion of 8-week mindfulness training intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Palatnik, MD | Contact | 14148056627 | apalatnik@mcw.edu | |
| Alyssa Hernandez, DO | Contact | 4149552781 | alyhernandez@mcw.edu |
| Name | Affiliation | Role |
|---|---|---|
| Anna Palatnik, MD | Medical College of Wisconsin | Principal Investigator |
| Margaret Bublitz, PhD | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brown University | Providence | Rhode Island | 02904 | United States |
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.
The repository will make the data accessible within 2 years of the last patient's last study visit or at the end of the performance period, or no later than the date of publication, whichever is sooner. Data will be preserved within the repositories for at least three years following the completion of the grant, as required by federal retention guidelines.
Data that are necessary for and of sufficient quality to validate and replicate the study findings for the primary aims will be shared. We agree that the data will be deposited and made available as public use data to the research community via BioLINCC, and that these data will be shared with investigators working under an institution with a Federal Wide Assurance (FWA) and can be used for secondary study purposes. We agree that the names and institutions of persons either given or denied access to the data, and the basis for such decisions, will be summarized in the annual progress report. Interested investigators will need to seek approval for data access from the contact PI.
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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All participants will wear a Garmin Vivoactive 4 biosensor watch throughout the study. However, only one of the arms will have real-time access to thier data, while the other 2 arms will be masked to their watch data. The study team will have access to the watch data for all 3 arms.
| Garmin Vivoactive 4 watch | Behavioral | Biofeedback with a wearable biosensor that continuously monitors heart rate variability and generates stress scores. |
|
| Home blood pressure | Average systolic and diastolic blood pressure measured using home blood pressure monitoring | 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 | 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 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 at baseline and 2, 3, and 4 months after consent. |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
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