About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Single group
Treatments tested in this trial
Follow up to Mindfulness RCT using a Still Face Paradigm
Other interventionMothers who participated in an RCT of mindfulness to prevent hypertensive disorders of pregnancy and their infants at 6 months of age will attend one session in which they are consented and prepared for the Still Face Paradigm (SFP). The SFP consists of a sequence of three, 2-minute episodes in which the parent and the infant are seated about one meter away from each other. Across a pre-task baseline, task episodes (free play and still-face), and recovery periods, mothers and infants will wear wireless heart rate monitors to assess respiratory sinus arrhythmia and heart rate. At 12 months, mothers will complete lab work to assess cardiovascular risk and infants' growth velocity will be culled from pediatric medical records.
Treatment groups
Trial outcomes
Primary outcomes
Maternal-Infant Stress reactivity
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 outcomes
Maternal cardiovascular risk biometrics
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.
Infant cardiovascular risk biometrics
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.
Sponsors and contacts
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Lifespan
Lead sponsor
National Institute of General Medical Sciences (NIGMS)
Collaborator
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