Stress Reactivity and Mother-Infant Cardiovascular Disease Risk

Not Applicable

Not yet recruiting

• Conditions: Infant Health; Psychophysiology; Cardiovascular Diseases; Cardiovascular Diseases Risk; Behavioral Medicine; Mindfulness; Maternal Health; Hypertension

• Registration Number: NCT06805799
• Lead Sponsor: Lifespan

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.

Study Timeline

• Study First Submitted: 2025-01-17
• Study First Submitted QC: 2025-01-28
• Status Verified: 2025-02
• Study First Posted: 2025-02-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-04
• Study Start: 2025-03-15
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 40

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Maternal-Infant Stress reactivity	Single episode of assessment at 6 months postpartum	Stress reactivity will be measured using respiratory sinus arrhythmia (RSA), collected during all phases of the Still Face Paradigm via wireless ECG monitors on both mothers and infants. Maternal-infant RSA synchrony value per 30-second epoch will be calculated using CardioBatch Plus Synchrony, which quantifies the amplitude of RSA with age-specific parameters that are sensitive to the maturational shifts in the frequency of spontaneous breathing, and is statistically equivalent to frequency domain methods (i.e., spectral analysis) for calculation of the amplitude of RSA when heart period data are stationary. RSA will be quantified during each sequential 30-s epoch within each condition of the SFP and then compared across treatment arms.

Secondary Outcome Measures

Name	Time	Method
Infant cardiovascular risk biometrics	Single assessment at 12 months postpartum	Birthweight, length, and gestational age at birth is being extracted from medical records during the parent study. Infant CVD Risk at 12 months of age will be measured by infant weight-for-length growth velocity (World Health Organization; z score) using these data.
Maternal cardiovascular risk biometrics	Single assessment at 12 months postpartum	Biomarkers of Cardiovascular Risk. This study leverage CVD biomarkers from the parent RCT at 12 months postpartum to test associations with maternal-infant stress reactivity. Several CVD biomarkers in postpartum women will be assessed via maternal serum (total cholesterol, LDL, HDL, triglycerides, high sensitivity C-reactive protein, and insulin resistance (HOMA-IR) using standard laboratory procedures ambulatory blood pressure monitoring, and anthropometric data collection (BMI). Maternal CVD risk at 12 months postpartum will be quantified using a composite risk score (ranging from 0-8), consistent with the method chosen by the parent RCT and recommendations from the World Health Organization and other CVD risk calculators.

Trial Locations

Locations (1)

Women's Medicine Collaborative, Lifespan; 🇺🇸 Providence, Rhode Island, United States