Stress Reactivity and Mother-Infant Cardiovascular Disease Risk

NCT06805799 | Not Yet Recruiting DMC

• 2 other identifiers: 1679889-635U54GM115677-09
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Single episode of assessment at 6 months postpartum

Secondary Outcomes (2)

• Maternal cardiovascular risk biometrics

  Single assessment at 12 months postpartum

• Infant cardiovascular risk biometrics

  Single assessment at 12 months postpartum

Study Arms (1)

Follow-up to Mindfulness RCT Using Still Face Paradigm

EXPERIMENTAL

Postpartum people who participated in either a mindfulness arm or TAU during an RCT examining prenatal mindfulness for pregnant people at risk for 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 (application of electrodes and RSA monitors, placement of video equipment). 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. During the first episode, the parent is free to play with the infant as they would at home. During the "still-face" episode (SF), the parent maintains a neutral face and is told not to touch or interact with the infant. The third episode is a resumption of play sometimes referred to as the "reunion" episode.

Other: Follow up to Mindfulness RCT using a Still Face Paradigm

Interventions

Follow up to Mindfulness RCT using a Still Face Paradigm OTHER

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.

Follow-up to Mindfulness RCT Using Still Face Paradigm

Eligibility Criteria

• Age: 6 Months+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• National Institute of General Medical Sciences (NIGMS): collaborator
• Lifespan: lead

Study Sites (1)

Women's Medicine Collaborative, Lifespan

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases

Central Study Contacts

Micheline R Anderson, PhD

CONTACT

401-606-3000; micheline_anderson@brown.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry and Human Behavior

Model Details: 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).

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: February 3, 2025
• Study Start: April 15, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)