Stress Reactivity and Mother-Infant Cardiovascular Disease Risk

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
Lifespan
Study ID
NCT06805799
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
6 Months - N/A
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
Apr 15, 2026
Status verified
Mar 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Follow-up to Mindfulness RCT Using Still Face Paradigm
    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.

Primary Outcome Measure

Maternal-Infant Stress reactivity [ Time Frame: Single episode of assessment at 6 months postpartum ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Women's Medicine Collaborative, LifespanProvidenceRhode Island02906
Micheline R Anderson, PhD
[email protected]
401-606-3000
Margaret Bublitz, PhD
[email protected]
Micheline R Anderson, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Providence, RI

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
Women's Medicine Collaborative, Lifespan· Providence, RI

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