Stress Reactivity and Mother-Infant Cardiovascular Disease Risk
NCT06805799 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-04-01
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.
Conditions
- Maternal Health
- Infant Health
- Hypertension
- Behavioral Medicine
- Mindfulness
- Psychophysiology
- Cardiovascular Diseases
- Cardiovascular Diseases Risk
Interventions
- OTHER
-
Follow up to Mindfulness RCT using a Still Face Paradigm
Mothers 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.
Sponsors & Collaborators
-
National Institute of General Medical Sciences (NIGMS)
collaborator NIH -
Lifespan
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 6 Months
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-04-15
- Primary Completion
- 2026-07-31
- Completion
- 2026-07-31
Countries
- United States
Study Locations
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