grant

Mechanisms of mindfulness training to prevent hypertensive disorders of pregnancy

Organization MIRIAM HOSPITALLocation PROVIDENCE, UNITED STATESPosted 1 Sept 2021Deadline 30 Jun 2027
NIHUS FederalResearch GrantFY202521+ years oldAccelerationActive Follow-upAdultAdult HumanAffectAffectiveAmentiaAmerican Heart AssociationAndroid AppAndroid ApplicationArteriesBP reductionBiological MarkersBiosensorBlood DiseasesBlood PressureCardiac ChronotropismCardiovascularCardiovascular Body SystemCardiovascular Organ SystemCardiovascular systemCausalityCell Phone ApplicationCell phone AppCellular Phone AppCellular Phone ApplicationClinical TrialsDementiaDiseaseDisorderDoppler UltrasoundEcological momentary assessmentEducation for InterventionEducational InterventionEducational process of instructingEtiologyExclusionExhibitsExposure toFetal GrowthFinancial costGenderGestationGoalsHealth Care SystemsHeart RateHeart VascularHematologic DiseasesHematological DiseaseHematological DisorderHigh Risk WomanHourHypertensionHypertension-Associated Pregnancy DisorderInfantInstruction InterventionInterventionLinkLonelinessLung DiseasesMaternal MortalityMeasuresMedicalMethodologyMethodsMind-Body InterventionMind-Body MedicineMindfulness ApproachMindfulness TherapyMindfulness TrainingMindfulness TreatmentMindfulness-based ApproachMindfulness-based TherapyMindfulness-based TrainingMindfulness-based TreatmentMonitorMothersNHLBINational Heart, Lung, and Blood InstituteNon-pharmacologic TherapyNonpharmacologic InterventionNonpharmacologic TherapyNonpharmacologic approachNonpharmacologic treatmentParticipantPathway interactionsPatientsPhonePhysiologicPhysiologic MonitoringPhysiologicalPhysiological MonitoringPregnancyPregnant WomenPreventative strategyPrevention strategyPreventive strategyProcessPulmonary DiseasesPulmonary DisorderRandomizedRelaxationResistanceRiskRisk ReductionSamplingSmart Phone AppSmart Phone ApplicationSmartphone AppStressTeachingTechnologyTelephoneTestingTraining InterventionUnited StatesUterusVascular Hypertensive DiseaseVascular Hypertensive DisorderWomanWristactive followupadulthoodapp on a smartphoneapplication on a smartphoneat-risk femalesat-risk womenbio-markersbiologic markerbiological sensorbiomarkerblood disorderblood pressure reductionbody sensorbody worn sensorcardiac disease riskcardiac disorder riskcardiovascular disease riskcardiovascular disorder riskcardiovascular riskcardiovascular risk factorcare as usualcausationcell phone based appcirculatory systemdisease causationdisease of the lungdisorder of the lungexpectant motherexpectant womenexpecting motherexpecting womenexperiencefemales at high riskfollow upfollow-upfollowed upfollowupheart disease preventionheart disease riskheart disorder preventionheart disorder riskheart rate variabilityhigh blood pressurehigh risk femaleshyperpiesiahyperpiesishypertensive diseasehypertensive disease during pregnancyhypertensive disease in pregnancyhypertensive disease of pregnancyhypertensive disorderhypertensive disorder during pregnancyhypertensive disorder in pregnancyhypertensive disorder of pregnancyiOS appiOS applicationiPhone AppiPhone Applicationimprovedin vivoindividuals who are pregnantinnovateinnovationinnovativeinsightinstructional interventionintra-uterine growthintrauterine growthlife-time risklifetime risklonelylower BPlower blood pressurelowers blood pressurelung disordermaternal deathmaternal morbiditymind body approachmind body medicine skillsmind body techniquesmind body therapymind body treatmentsmind body wellnessmindfulnessmindfulness interventionmindfulness-based interventionmobile phone appmonetary costmortalitynegative affectnegative affectivitynew therapeutic approachnew therapeutic interventionnew therapeutic strategiesnew therapy approachesnew treatment approachnew treatment strategynon-drug therapynon-drug treatmentnondrug therapynondrug treatmentnovel therapeutic approachnovel therapeutic interventionnovel therapeutic strategiesnovel therapy approachpathwaypeople who are pregnantphone appphone applicationpregnancy induced hypertensive disorderpregnancy related hypertensive diseasepregnancy-specific hypertensive disorderpregnant femalespregnant motherspregnant peoplepregnant populationsprehypertensionprenatalpreventprevent heart diseasepreventingpsychologicpsychologicalrandomisationrandomizationrandomized, clinical trialsrandomly assignedreduce BPreduce blood pressurereduce riskreduce risksreduce that riskreduce the riskreduce these risksreduces riskreduces the riskreducing riskreducing the riskreduction in BPreduction in blood pressureresistantresponserisk-reducingsmartphone applicationsmartphone based appsmartphone based applicationstress bufferingstress managementtheoriesthose who are pregnanttreatment as usualunbornusual carewearablewearable biosensorwearable devicewearable electronicswearable sensorwearable sensor technologywearable systemwearable technologywearable toolwearableswombwomen at high riskwomen who are pregnant
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Full Description

Hypertensive disorders of pregnancy are the most common medical condition affecting pregnancy and a leading cause of maternal morbidity and mortality in the United States. Hypertensive disorders of pregnancy increase lifetime cardiac disease risk in females and infants exposed during pregnancy and are considered an independent, sex-specific cardiovascular risk factor by the American Heart Association. Current interventions to prevent hypertensive disorders of pregnancy are extremely limited and minimally effective. Mindfulness-based interventions hold significant promise as a non-pharmacological intervention to prevent hypertensive disorders of pregnancy; mindfulness-based interventions significantly reduce blood pressure in adults with hypertension and prehypertension.

However, prenatal clinical trials of mindfulness-based interventions have excluded females at risk for hypertensive disorders of pregnancy from participating and have not examined effects of mindfulness on maternal cardiovascular parameters. Our pilot RCT of prenatal mindfulness training for females at risk for hypertensive disorders of pregnancy demonstrated medium to large effects on maternal cardiovascular parameters of risk for hypertensive disorders of pregnancy, including lower ambulatory blood pressure and accelerated fetal growth velocity. However, the mechanisms explaining effects of prenatal mindfulness training on indicators of risk for hypertensive disorders of pregnancy are unknown. Building upon these promising preliminary findings, the proposed RCT will harness subjective and objective ecological momentary assessment (EMA) methodologies (in vivo repeated assessments) in combination with wearable biosensor technology to capture rich epochs of ecologically-valid psychological (Aim 1), physiological (Aim 2), and interpersonal (Aim 3) processes through which mindfulness training may lead to improved maternal cardiovascular parameters and reduced risk for hypertensive disorders of pregnancy.

N=150 pregnant people at risk for HDP will be randomized to an 8-week phone-delivered mindfulness intervention or usual care. For every participant, we will measure maternal cardiovascular parameters (24-hour blood pressure and uterine artery resistance values by ultrasound Doppler) before and after the RCT. All participants will complete EMA for 2 weeks ‘bursts’ before and after the RCT to evaluate mechanisms of mindfulness training on maternal cardiovascular parameters. EMA will include smartphone-app based experience sampling of psychological processes; smartphone-app based ambient audio sampling (i.e. the Electronically Activated Recorder [EAR] method) and wearable wrist-worn biosensor monitoring (heart rate and heart rate variability) of physiological responses to everyday experiences.

Results will provide new insights into 1) effects of mindfulness training on cardiovascular parameters in pregnancy, 2) pathophysiological mechanisms of hypertensive disorders of pregnancy, and 3) new targets for prevention strategies.

Grant Number: 5R01HL157288-05
NIH Institute/Center: NIH

Principal Investigator: Margaret Bublitz

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