MINDBP - Mindfulness and Wearable Biosensors to Prevent Hypertensive Disorders of Pregnancy

Medical College Of Wisconsin, Milwaukee WI

Investigators

Abstract

PROJECT SUMMARY/ABSTRACT Hypertensive disorders of pregnancy (HDP) are the most common medical condition affecting pregnancy and a leading cause of maternal morbidity and mortality in the United States. HDP increase lifetime cardiac disease risk in women and infants exposed during pregnancy and are considered an independent cardiovascular risk factor by the American Heart Association. Consequences of HDP extend well past the perinatal period; women with HDP are twice as likely to develop heart disease in their lifetime, and offspring exposed to HDP in utero face significant lifetime cardiovascular disease risk. Importantly, HDP are driving an increase in other adverse pregnancy outcomes and increasing costs of care. Current prevention strategies are limited and only partially effective. Mindfulness-based interventions hold significant promise as a non-pharmacological intervention to prevent HDP. Mindfulness-based interventions significantly reduce blood pressure in adults with hypertension and prehypertension. In single-site studies, our team has demonstrated that prenatal phone-delivered mindfulness training (MT) intervention is feasible and acceptable, shows high participant retention and protocol adherence, and demonstrates reductions in prenatal blood pressure and recurrence of HDP. Now, we seek to determine if prenatal MT intervention can be feasible, acceptable, and delivered with fidelity across multiple sites. In addition, we will explore whether our intervention can have even higher adherence with minor enhancement using wearable biosensors as they hold great potential to augment the beneficial effects of MT by enabling continuous, real-time, and non-invasive monitoring of physiological responses. Therefore, consistent with the limited competition notice of funding opportunity (RFA-AT-25-002), the goal of this multi-site clinical trial, titled: “Mindfulness and Wearable Biosensors to Prevent Hypertensive Disorders of Pregnancy - MINDBP” is to test a 16-week (8 weekly session plus two monthly booster sessions), three-arm, non- pharmacological intervention that includes MT and wearable biosensor feedback among 90 pregnant women at high risk for HDP. In Aim 1 we will assess feasibility and fidelity of MINDBP delivery across sites. In Aim 2 we will evaluate the acceptability of MINDBP by assessing participants’ satisfaction, engagement, and perceived usefulness of the intervention (Aim 2). In Aim 3 we will finalize components of MINDBP for future trial by examining change in psychological and physiological response (blood pressure, heart rate variability, perceived stress, and pregnancy-specific anxiety) within each study arm. The MINDBP study will generate necessary data to inform a future large-scale trial examining effectiveness of MT in HDP prevention. Data collected under this R01 will fill important gaps in scientific knowledge necessary and sufficient to establish operational feasibility and design of the larger multisite trial that will generate evidence to guide scalable complementary and integrative HDP prevention strategies.