Clinical trial NCT06805799: Stress Reactivity and Mother-Infant Cardiovascular Disease Risk
Official title: Maternal-Infant Stress Reactivity as an Intergenerational Pathway to Cardiovascular Disease Risk
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Maternal Health
Infant Health
Hypertension
Behavioral Medicine
Mindfulness
Psychophysiology
Cardiovascular Diseases
Cardiovascular Diseases Risk
Keywords: Mindfulness
Psychophysiology
Coregulation
Maternal-infant Coregulation
Cardiovascular Disease Risk
Hypertension
Lead sponsor: Lifespan
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2025-02-03
Enrollment: 40
Sex: FEMALE
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a follow-up study to an RCT of prenatal mindfulness vs. TAU for pregnant women at risk for hypertensive disorder of pregnancy. At 6 months postpartum, all participants who consent to this follow-up study will engage with the Still Face Paradigm, a well-validated lab-based protocol that elicits behavioral and physiological reactivity from mother and infant. Individual and dyadic physiological reactivity will be examined in relation to mother and infant biomarkers of cardiovascular risk at 12 months postpartum. Self and dyadic participant responses to the SFP will then be compared by treatment arm (MT vs. TAU).
Primary purpose: OTHER

Brief summary: Prenatal Mindfulness training (MT) shows promise as a preventive intervention against hypertensive disorders of pregnancy (HDP) and may reduce risk for offspring cardiovascular disease (CVD). One proposed mechanism of MT to reduced CVD risk is improved self-regulation following stress. Perhaps the most crucial contributor to the development of self-regulation in the first year is the psychophysiological coregulatory relationship between mother and infant. However, this self-and co-regulation among women exposed to prenatal MT has not been studied and has yet to be examined in relation to CVD risk. The goal of this proposed project is to evaluate maternal-infant physiological reactivity to and recovery from stress at 6 months postpartum following prenatal MT, and to examine the relationship between these maternal infant stress responses and maternal-infant CVD risk at 12 months postpartum.

Using a lab-based stress paradigm and well-validated biomarkers of mother and infant CVD risk, the investigators will assess respiratory sinus arrhythmia and heart rate at 6 months postpartum for 40 mother-infant dyads who have completed either prenatal MT or a usual care arm of an RCT examining MT for women at risk for HDP. The investigators will compare maternal, infant, and dyadic stress responses by treatment arm. Then, cardiac stress responses will be examined as predictors of maternal and infant biomarkers of CVD risk at 12 months postpartum.

Detailed description: Hypertensive disorders of pregnancy (HDP) affect 1 out of 10 pregnancies, contribute annually to over two billion dollars of health care utilization costs, and are a leading cause of maternal morbidity and mortality in the United States. HDP confer long-term cardiovascular disease (CVD) risk for both mother and infant. Thus, prevention of prenatal HDP is essential to reducing intergenerational transmission of CVD risk. Prenatal mindfulness training (MT) has shown promise as a non-pharmacological intervention to prevent HDP and is associated with improved mother-infant outcomes at birth. Benefits of prenatal MT on maternal-infant stress responses and concomitant effects on CVD risk have not been examined.

One proposed mechanism thought to confer cardiovascular benefits of MT is improved physiological stress response via the autonomic nervous system (ANS). ANS dysfunction has been linked with early childhood physical health concerns, such as obesity and elevated blood pressure, and increased CVD risk in adulthood, and thus may be a significant target for interventions aiming to disrupt intergenerational risk for CVD.There is emerging evidence that prenatal MT interventions may improve sympathetic reactivity to and recovery from stress (as measured by pre-ejection period activity) in 6-month old infants. Biobehavioral frameworks of attachment propose that mother-child dyads engage in physiological coregulation that influences self-regulatory processes. Maternal-infant synchrony of heartbeat and motor activity begins in utero and may promote children's physical and behavioral health. Concordance of maternal-infant self-regulation in stressful situations, a proxy of adaptive psychophysiological reactivity, may thus be associated with reduced CVD risk. However, it is not yet known whether prenatal MT is associated with improved maternal-infant regulation of ANS responses to stress, or whether these responses are associated with maternal and pediatric cardiovascular outcomes. These data are essential for the development of targeted parenting interventions that promote adaptive coregulatory stress responses and disrupt postpartum pathways for intergenerational CVD risk.

To address this knowledge gap, this study will examine effects of a prenatal MT intervention on postpartum maternal-infant psychophysiological coregulatory processes that may decrease maternal and infant CVD. The study will leverage the data and infrastructure from an ongoing RCT (PI: Mentor Bublitz; R01HL157288) examining mechanisms of a prenatal MT intervention on the prevention of HDP. At 6 months postpartum, maternal-infant physiological reactivity to stress will be assessed. At 12 months postpartum, maternal and infant CVD risk will be measured. This study aims to: 1) Evaluate psychophysiological responses to stress in women randomized to MT vs usual care and their offspring and 2) Evaluate the relationship between maternal-infant psychophysiological responses to stress and cardiovascular markers of disease risk. Using innovative assessment and analysis of self-and coregulation, results will provide insights into whether and how prenatal mindfulness impacts stress reactivity for mothers and their infants and, for the first time, whether coregulatory physiology is linked with cardiovascular disease risk.

Eligibility criteria: Inclusion Criteria:

* For the parent RCT study: Inclusion criteria: singleton pregnancy, English speaking, \>18 years old, \<20 weeks' gestation at enrollment, normotensive at enrollment, and criteria consistent with 'moderate' to 'high' risk for preeclampsia based on American College of Obstetrician and Gynecologist guidelines. For the current research study: Participants will be (n=40) individuals from the parent RCT who have consented to be contacted for future research in the parent study and are not pregnant during the mentored research study procedures.

Exclusion Criteria:

For the parent RCT study: Exclusion criteria: multiple gestations; chronic hypertension; active suicidality or psychosis; ongoing mind-body practice (e.g., yoga, meditation, mindfulness \> once a week).

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Primary outcomes:
measure: Maternal-Infant Stress reactivity
timeFrame: Single episode of assessment at 6 months postpartum
Secondary outcomes:
measure: Maternal cardiovascular risk biometrics
timeFrame: Single assessment at 12 months postpartum
measure: Infant cardiovascular risk biometrics
timeFrame: Single assessment at 12 months postpartum
Other outcomes:
Locations:
city: Providence
country: United States
facility: Women's Medicine Collaborative, Lifespan
state: Rhode Island
Study officials:
References: