[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07218237":3,"trial-entities:NCT07218237":129,"trial-summary:NCT07218237":133},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":43,"secondary_outcomes":48,"sex":68,"minimum_age":69,"maximum_age":70,"healthy_volunteers":71,"eligibility_criteria":72,"std_ages":85,"locations":88,"central_contacts":120,"overall_officials":123,"references":127,"see_also_links":128},"NCT07218237","PRO00056473","Mindfulness and Wearable Biosensors to Prevent Hypertensive Disorders of Pregnancy","Mindfulness and Wearable Biosensors to Prevent Hypertensive Disorders of Pregnancy Study: MINDBP","RECRUITING","2028-10","2026-07","2026-07-20","2026-04-28","Medical College of Wisconsin","OTHER",true,"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",[19],"Preeclampsia",[21,22,23],"Hypertensive disorders of pregnancy","Mindfulness","Biofeedback","INTERVENTIONAL","PREVENTION",[27],"NA",{"count":29,"type":30},90,"ESTIMATED",[32,39],{"type":33,"name":34,"description":35,"armGroupLabels":36},"BEHAVIORAL","Mindfulness training","Mindfulness training with trained instructors",[37,38],"MT","MT + Biofeedback",{"type":33,"name":40,"description":41,"armGroupLabels":42},"Garmin Vivoactive 4 watch","Biofeedback with a wearable biosensor that continuously monitors heart rate variability and generates stress scores.",[38],[44],{"measure":45,"description":46,"timeFrame":47},"Feasibility of multisite RCT","Assess study feasibility as measured by retention rate","3 years",[49,53,57,61,65],{"measure":50,"description":51,"timeFrame":52},"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.",{"measure":54,"description":55,"timeFrame":56},"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",{"measure":58,"description":59,"timeFrame":60},"Heart rate variability","Average daily stress score based on heart rate variability from biosensor watch","Up to 34 weeks",{"measure":62,"description":63,"timeFrame":64},"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.",{"measure":66,"description":67,"timeFrame":64},"Pregnancy-related anxiety","Self-reported pregnancy-related anxiety using the PRAQ-R2, which is cored from 0-40, with higher scores indicating higher anxiety.","FEMALE","18 Years",null,false,{"inclusion":73,"exclusion":78,"raw_text":84},[74,75,76,77],"Pregnant patients at gestational age \\\u003C= 16 weeks","Live, non-anomalous gestation","Normotensive at enrollment","Meet criteria consistent with 'moderate' to 'high' risk for preeclampsia based on ACOG\u002FUSPSTF guidelines for low-dose aspirin administration to prevent hypertensive disorders of pregnancy",[79,80,81,82,83],"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)","Inclusion Criteria:\n\n* Pregnant patients at gestational age \\\u003C= 16 weeks\n* Live, non-anomalous gestation\n* Normotensive at enrollment\n* Meet criteria consistent with 'moderate' to 'high' risk for preeclampsia based on ACOG\u002FUSPSTF guidelines for low-dose aspirin administration to prevent hypertensive disorders of pregnancy\n\nExclusion Criteria:\n\n* Multiple gestation\n* Chronic (pregestational hypertension)\n* Inability of unwillingness to provide informed consent\n* Active suicidality or psychosis\n* Ongoing mind-body practice (e.g., yoga, meditation, mindfulness \\>= once per week)",[86,87],"ADULT","OLDER_ADULT",[89,104],{"facility":90,"status":8,"city":91,"state":92,"zip":93,"country":94,"contacts":95,"geoPoint":101},"Brown University","Providence","Rhode Island","02904","United States",[96],{"name":97,"role":98,"phone":99,"email":100},"Margaret Bublitz, PhD","CONTACT","401-793-7884","mbublitz@brownhealth.org",{"lat":102,"lon":103},41.82399,-71.41283,{"facility":13,"status":8,"city":105,"state":106,"zip":107,"country":94,"contacts":108,"geoPoint":117},"Milwaukee","Wisconsin","53226",[109,113],{"name":110,"role":98,"phone":111,"email":112},"Anna Palatnik, MD","14148056627","apalatnik@mcw.edu",{"name":114,"role":98,"phone":115,"email":116},"Alyssa Hernandez, DO","4149552781","alyhernandez@mcw.edu",{"lat":118,"lon":119},43.0389,-87.90647,[121,122],{"name":110,"role":98,"phone":111,"email":112},{"name":114,"role":98,"phone":115,"email":116},[124,126],{"name":110,"affiliation":13,"role":125},"PRINCIPAL_INVESTIGATOR",{"name":97,"affiliation":90,"role":125},[],[],{"nct_id":4,"conditions":130,"biomarkers":132},[19,131],"Toxemia of Pregnancy",[],{"nct_id":4,"found":15,"summary":134,"prompt_version":144},{"design":135,"status":136,"heading":137,"summary":138,"follow_up":139,"word_count":140,"commitments":141,"compensation":142,"drugs_mentioned":143},"This is an interventional study that will randomly assign 90 participants to one of three groups. The study status is unclear.","completed","Mindfulness and Wearable Biosensors for Preeclampsia Prevention","This study, called MINDBP, is looking at whether mindfulness training and using a Garmin Vivoactive 4 watch can help prevent preeclampsia (a serious pregnancy complication involving high blood pressure). You might be able to join if you are pregnant, up to 16 weeks along, and considered at moderate to high risk for preeclampsia. The study will enroll 90 women and compare three groups: mindfulness training with the wearable watch, mindfulness training alone, or standard prenatal care. The main goal is to see if this type of study is practical to conduct across different locations.","The primary outcome of study feasibility is measured at 3 years.",94,"Participants will receive 8 weekly phone-based mindfulness sessions, plus two booster sessions at 1 and 2 months after the main intervention. All participants will wear a Garmin Vivoactive 4 watch. Blood pressure, heart rate, and stress levels will be measured at baseline, after the main intervention, and after each booster session.","Not stated in the trial record.",[34,40],"v2"]