Maternal HealthNCT06805799
Stress Reactivity and Mother-Infant Cardiovascular Disease Risk
A study testing Follow up to Mindfulness RCT using a Still Face Paradigm in people with Maternal Health and Infant Health, run by Lifespan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Health, Infant Health, Hypertension
- What is being tested?
- Follow up to Mindfulness RCT using a Still Face Paradigm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2026to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Women's Medicine Collaborative, Lifespan
Providence, Rhode Island, 02906
Micheline R Anderson, PhD, 401-606-3000, micheline_anderson@brown.edu
Margaret Bublitz, PhD, margaret_bublitz@brown.edu
About this study
Official title: Maternal-Infant Stress Reactivity as an Intergenerational Pathway to Cardiovascular Disease Risk
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.
Read the 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.
- Conditions
- Maternal Health, Infant Health, Hypertension, Behavioral Medicine, Mindfulness, Psychophysiology
- Being tested
- Follow up to Mindfulness RCT using a Still Face Paradigm
- Keywords
- Mindfulness, Psychophysiology, Coregulation, Maternal-infant Coregulation, Cardiovascular Disease Risk, Hypertension
- Medical subject headings
- Hypertension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow up to Mindfulness RCT using a Still Face ParadigmOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Follow up to Mindfulness RCT using a Still Face Paradigm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Single episode of assessment at 6 months postpartum
Secondary outcomes (2)
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.
Measured: Single assessment at 12 months postpartum
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.
Measured: Single assessment at 12 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start15 Apr 2026 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lifespan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Micheline Anderson, Lifespan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06805799
- Sponsor's protocol ID
- 1679889-63
- Other IDs
- 5U54GM115677-09
- Status last verified
- Mar 2026
- First submitted
- 17 Jan 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal-Infant Stress Reactivity as an Intergenerational Pathway to Cardiovascular Disease Risk
- ClinicalTrials.gov ID
- NCT06805799
- Acronym / sponsor ID
- 1679889-63
- Conditions
- Maternal Health, Infant Health, Hypertension, Behavioral Medicine, Mindfulness, Psychophysiology
- Keywords
- Mindfulness, Psychophysiology, Coregulation, Maternal-infant Coregulation, Cardiovascular Disease Risk, Hypertension
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- LifespanUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Follow-up to Mindfulness RCT Using Still Face Paradigm | Experimental | Other: Follow up to Mindfulness RCT using a Still Face ParadigmPostpartum 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. |
Who may qualify
- Ages
- 6 months and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follow up to Mindfulness RCT using a Still Face ParadigmMothers 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. | Other | Follow-up to Mindfulness RCT Using Still Face Paradigm |
Primary outcome
Maternal-Infant Stress reactivity
Time frame: 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.
2 secondary outcomes
Maternal cardiovascular risk biometrics
Time frame: Single assessment at 12 months postpartum
Infant cardiovascular risk biometrics
Time frame: Single assessment at 12 months postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Follow up to Mindfulness RCT using a Still Face Paradigm in people with Maternal Health and Infant Health, run by Lifespan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Micheline R Anderson, PhD (401-606-3000, micheline_anderson@brown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal-Infant Stress reactivity (time frame: Single episode of assessment at 6 months postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.