Maternal Cardiometabolic HealthNCT06898658
Conscious Pregnancy: Supporting Maternal Cardiometabolic Health With Mindfulness
A study testing Mindfulness Intervention in people with Maternal Cardiometabolic Health and Molecular Impact of Psychological Stress and Socioeconomic Adversity, run by University of California, Irvine at 1 site in United States.
Trial summary
A pilot randomized control trial (RCT) to examine the efficacy of a culturally tailored mindfulness intervention upon fasting cardiometabolic factors (including markers of glycemic control) and inflammatory gene expression in n=20 (n=10 intervention, n=10 wait-list control) low-income Spanish-speaking Latina pregnant… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Cardiometabolic Health, Molecular Impact of Psychological Stress and Socioeconomic Adversity, Maternal Inflammatory Markers
- What is being tested?
- Mindfulness Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2025to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Singleton, intrauterine pregnancy
- 1st or 2nd trimester at enrollment
- Fluent in Spanish
- Self-identify as Hispanic/Latino
- Low-income
Who cannot join
- Having regular mindfulness practice
- T1 or T2D diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mindfulness and Cardiometabolic Health for Spanish Speaking Latina Pregnant Women: A Community-informed Project Targeting Inflammatory Gene Expression and Glycemic Control
A pilot randomized control trial (RCT) to examine the efficacy of a culturally tailored mindfulness intervention upon fasting cardiometabolic factors (including markers of glycemic control) and inflammatory gene expression in n=20 (n=10 intervention, n=10 wait-list control) low-income Spanish-speaking Latina pregnant women. The study will be conducted in partnership with MOMS, a nonprofit community organization that serves low-income pregnant and postpartum women.
Read the detailed description
Prenatal health interventions have the potential to shape the future health of both mothers and offspring. Given that the Latino population is disproportionately affected by high rates of obesity and type 2 diabetes, targeted prenatal health interventions that support Latina metabolic health are fundamental to reduce the burden of Latino health disparities within and across generations. Research in primarily non-Hispanic White populations suggests that prenatal mindfulness interventions can not only improve maternal mental health outcomes and well-being, but additionally can support systemic physiological health, such as improved glycemic control and reduced gestational weight gain. However, research on the acceptability and feasibility of mindfulness programs for Latino populations is limited, especially among those who are Spanish-speaking and affected by poverty. Focus groups conducted with this target population, have highlighted a strong interest in mindfulness programs, with a need for novel hybrid instruction format (live classes + digital at-home content). Accordingly, the investigators have developed an adapted, hybrid version of the validated 6-week Mindfulness Awareness Practices (MAPs) training program in Spanish and English.
Here, the investigators plan to pilot and examine the efficacy of this culturally tailored mindfulness intervention upon cardiometabolic factors, including inflammatory gene expression and glycemic control markers, in a low-income Spanish-speaking Latina pregnant population (n=20; n=10 intervention, n=10 wait-list control). Specifically, the investigators will examine the intervention impact on cardiometabolic markers (e.g., fasting glucose and insulin, Hemoglobin A1c (HbA1c), C-reactive protein (CRP), lipids), and inflammatory gene expression measurement. Maternal mental well-being, pregnancy and birth outcomes will also be assessed.
- Conditions
- Maternal Cardiometabolic Health, Molecular Impact of Psychological Stress and Socioeconomic Adversity, Maternal Inflammatory Markers, Maternal Diabetes, Maternal Behavior, Maternal Distress
- Being tested
- Mindfulness Intervention
- Medical subject headings
- Financial Stress, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness InterventionBehavioural
Hybrid MAPs course will be delivered by a Spanish-speaking Latina certified mindfulness instructor, with a blend of in-person instruction, online instruction and asynchronous (audio-recorded) content instruction over 6-wks. There will be three live-2hr classes (2 in-person, 1 online) and three 3 weeks of 1-hr self-guided audio/week asynchronous content (1hr/wk). Additionally, the instructor will invite the intervention group to join optional weekly via Zoom 1x/wk for 30-min sessions for time to encourage questions, dialogue, and brief group mindfulness practice opportunities.
Class attendance and engagement with audio-recorded materials will be tracked. The study team will call or text participants weekly to maintain engagement, remind about any upcoming scheduled classes, and answer any questions. Participant attendance in classes (in-person and zoom) will be monitored.
| Study group | Role | What they receive |
|---|---|---|
| Wait-List Control Group | No intervention | Participants randomized to control will continue their usual care (MOMS at-home visitation schedule) and will provide concordant pre- and post-intervention data alongside the intervention group. They will receive audio recordings of all mindfulness instructional material after the 6-week intervention and post-intervention data collection is complete. |
| Mindfulness Intervention Group | Experimental | The culturally tailored mindfulness program will be delivered in a hybrid format and is an adaptation of the validated Mindfulness Awareness Practices (MAPs), which has been utilized in Spanish speaking Latino populations and in the context of pregnancy. MAPs trains one in the systematic practice of attending to moment-by-moment experiences, thoughts, and emotions from a nonjudgmental perspective, and is more accessible to diverse and socioeconomically disadvantaged populations relative to standard mindfulness-based Interventions, as it does not require a day-long retreat or yoga practice. Receives: Behavioral: Mindfulness Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Pro-Inflammatory Gene Expression
The primary outcome is maternal pro-inflammatory gene expression, as determined from pre-post intervention change in pre-specified transcriptional regulation factors from the conserved transcriptional response to adversity (CTRA) (e.g., proinflammatory nuclear factor κB (NF-κB)). Gene expression will be quantified from dried blood spots (DBS). Comparison of intervention and control group will occur pre and post mindfulness intervention.
Measured: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention
High Sensitivity C-Reactive Protein
High sensitivity c-reactive protein (hs-CRP) is a circulating marker of systemic inflammation. hs-CRP will be measured in dried blood spots (DBS) and reported in mg/L units.
Measured: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention
Fasting Glucose
Fasting glucose will be measured using a glucometer and reported in mg/dL.
Measured: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention
Hemoglobin A1c (HbA1c)
Hemoglobin A1c (HbA1c) will be measured in DBS and reported as a percentage (%), which indicates the proportion of hemoglobin molecules that are coated with glucose.
Measured: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention
Fasting Insulin
Fasting insulin will be measured via DBS and reported in uIU/mL units.
Measured: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention
Lipid Panel
Fasting apolipoprotein A (ApoA1), apolipoprotein B (ApoB), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), total cholesterol, and triglycerides will be collected via DBS and reported in mg/dL units.
Measured: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention
Secondary outcomes (7)
Perceived Stress Scale (PSS)
Perceived stress will be measured using the validated 4-item perceived stress scale (PSS), with a higher score indicated greater perceived stress (scale range 0-16).
Measured: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention
Edinburgh Postnatal Depression Scale (EPDS)
Depressive symptomatology will be measured with the validated 10-item Edinburgh Postnatal Depression Scale (EPDS). A higher score indicates greater depressive symptomatology and a score >= 13 indicates high risk for depression (scale range 0-30).
Measured: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention
Five Facet Mindfulness Questionnaire (FFMQ)
The validated15-item five facet mindfulness questionnaire (FFMQ) will be used to assess mindfulness, with a higher score indicating greater mindfulness with regards to thoughts, experiences, and actions in daily life (scale range 15-75).
Measured: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention
Pregnancy-related anxiety (PRAQ-R2)
The validated 10-item pregnancy-related anxiety scale revised-2 (PRAQ-R2) will be used to assess prenatal anxiety, with higher scores indicating greater pregnancy-related anxiety (scale range 10-50).
Measured: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention
State-Trait Anxiety Inventory (STAI)
State anxiety will be measured using the validated state-trait anxiety inventory (STAI). The state anxiety subscale will quantify the perceptions of anxiety in the present moment, with higher scores indicating greater self-report of anxiety (scale range 6-24).
Measured: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention
Spot Morning Cortisol Sample
Fasting morning cortisol will be measured in DBS and reported in ug/dL units. Time since waking will be recorded and accounted for in analyses.
Measured: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention
Homocysteine
Homocysteine will be measured via DBS and reported in umol/L units. Higher homocysteine levels are linked to increased inflammation.
Measured: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start27 Mar 2025
- Primary completion1 Aug 2025
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal Cardiometabolic HealthStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Lauren Gyllenhammer, University of California, Irvine
- Investigators
- Lauren E Gyllenhammer, PhD, Principal investigator, University of California, IrvineKaren L Lindsay, RD, PhD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06898658
- Sponsor's protocol ID
- 4967
- Other IDs
- P50MD017344
- Status last verified
- May 2026
- First submitted
- 19 Mar 2025
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness and Cardiometabolic Health for Spanish Speaking Latina Pregnant Women: A Community-informed Project Targeting Inflammatory Gene Expression and Glycemic Control
- ClinicalTrials.gov ID
- NCT06898658
- Acronym / sponsor ID
- 4967
- Conditions
- Maternal Cardiometabolic Health, Molecular Impact of Psychological Stress and Socioeconomic Adversity, Maternal Inflammatory Markers, Maternal Diabetes, Maternal Behavior, Maternal Distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 27 Mar 2025 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 27 Mar 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.
A pilot randomized control trial (RCT) to examine the efficacy of a culturally tailored mindfulness intervention upon fasting cardiometabolic factors (including markers of glycemic control) and inflammatory gene expression in n=20 (n=10 intervention, n=10 wait-list control) low-income Spanish-speaking Latina pregnant women. The study will be conducted in partnership with MOMS, a nonprofit community organization that serves low-income pregnant and postpartum women.
Detailed description
Prenatal health interventions have the potential to shape the future health of both mothers and offspring. Given that the Latino population is disproportionately affected by high rates of obesity and type 2 diabetes, targeted prenatal health interventions that support Latina metabolic health are fundamental to reduce the burden of Latino health disparities within and across generations. Research in primarily non-Hispanic White populations suggests that prenatal mindfulness interventions can not only improve maternal mental health outcomes and well-being, but additionally can support systemic physiological health, such as improved glycemic control and reduced gestational weight gain. However, research on the acceptability and feasibility of mindfulness programs for Latino populations is limited, especially among those who are Spanish-speaking and affected by poverty. Focus groups conducted with this target population, have highlighted a strong interest in mindfulness programs, with a need for novel hybrid instruction format (live classes + digital at-home content). Accordingly, the investigators have developed an adapted, hybrid version of the validated 6-week Mindfulness Awareness Practices (MAPs) training program in Spanish and English.
Here, the investigators plan to pilot and examine the efficacy of this culturally tailored mindfulness intervention upon cardiometabolic factors, including inflammatory gene expression and glycemic control markers, in a low-income Spanish-speaking Latina pregnant population (n=20; n=10 intervention, n=10 wait-list control). Specifically, the investigators will examine the intervention impact on cardiometabolic markers (e.g., fasting glucose and insulin, Hemoglobin A1c (HbA1c), C-reactive protein (CRP), lipids), and inflammatory gene expression measurement. Maternal mental well-being, pregnancy and birth outcomes will also be assessed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wait-List Control Group | No intervention | –Participants randomized to control will continue their usual care (MOMS at-home visitation schedule) and will provide concordant pre- and post-intervention data alongside the intervention group. They will receive audio recordings of all mindfulness instructional material after the 6-week intervention and post-intervention data collection is complete. |
| Mindfulness Intervention Group | Experimental | Behavioral: Mindfulness InterventionThe culturally tailored mindfulness program will be delivered in a hybrid format and is an adaptation of the validated Mindfulness Awareness Practices (MAPs), which has been utilized in Spanish speaking Latino populations and in the context of pregnancy. MAPs trains one in the systematic practice of attending to moment-by-moment experiences, thoughts, and emotions from a nonjudgmental perspective, and is more accessible to diverse and socioeconomically disadvantaged populations relative to standard mindfulness-based Interventions, as it does not require a day-long retreat or yoga practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Singleton, intrauterine pregnancy
- 1st or 2nd trimester at enrollment
- Fluent in Spanish
- Self-identify as Hispanic/Latino
- Low-income
Key exclusion criteria (2 listed)
- Having regular mindfulness practice
- T1 or T2D diagnosis
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 |
|---|---|---|
| Mindfulness InterventionHybrid MAPs course will be delivered by a Spanish-speaking Latina certified mindfulness instructor, with a blend of in-person instruction, online instruction and asynchronous (audio-recorded) content instruction over 6-wks. There will be three live-2hr classes (2 in-person, 1 online) and three 3 weeks of 1-hr self-guided audio/week asynchronous content (1hr/wk). Additionally, the instructor will invite the intervention group to join optional weekly via Zoom 1x/wk for 30-min sessions for time to encourage questions, dialogue, and brief group mindfulness practice opportunities. Class attendance and engagement with audio-recorded materials will be tracked. The study team will call or text participants weekly to maintain engagement, remind about any upcoming scheduled classes, and answer any questions. Participant attendance in classes (in-person and zoom) will be monitored. | Behavioural | Mindfulness Intervention Group |
Primary outcome
Maternal Pro-Inflammatory Gene Expression
Time frame: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention
The primary outcome is maternal pro-inflammatory gene expression, as determined from pre-post intervention change in pre-specified transcriptional regulation factors from the conserved transcriptional response to adversity (CTRA) (e.g., proinflammatory nuclear factor κB (NF-κB)). Gene expression will be quantified from dried blood spots (DBS). Comparison of intervention and control group will occur pre and post mindfulness intervention.
High Sensitivity C-Reactive Protein
Time frame: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention
High sensitivity c-reactive protein (hs-CRP) is a circulating marker of systemic inflammation. hs-CRP will be measured in dried blood spots (DBS) and reported in mg/L units.
Fasting Glucose
Time frame: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention
Fasting glucose will be measured using a glucometer and reported in mg/dL.
Hemoglobin A1c (HbA1c)
Time frame: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention
Hemoglobin A1c (HbA1c) will be measured in DBS and reported as a percentage (%), which indicates the proportion of hemoglobin molecules that are coated with glucose.
Fasting Insulin
Time frame: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention
Fasting insulin will be measured via DBS and reported in uIU/mL units.
Lipid Panel
Time frame: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention
Fasting apolipoprotein A (ApoA1), apolipoprotein B (ApoB), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), total cholesterol, and triglycerides will be collected via DBS and reported in mg/dL units.
7 secondary outcomes
Perceived Stress Scale (PSS)
Time frame: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention
Edinburgh Postnatal Depression Scale (EPDS)
Time frame: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention
Five Facet Mindfulness Questionnaire (FFMQ)
Time frame: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention
Pregnancy-related anxiety (PRAQ-R2)
Time frame: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention
State-Trait Anxiety Inventory (STAI)
Time frame: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention
Spot Morning Cortisol Sample
Time frame: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention
Homocysteine
Time frame: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 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. This study is not recruiting at the moment.
Lauren E Gyllenhammer, PhD principal investigator
University of California, Irvine
Karen L Lindsay, RD, PhD principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Intervention in people with Maternal Cardiometabolic Health and Molecular Impact of Psychological Stress and Socioeconomic Adversity, run by University of California, Irvine 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 5 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: finished, as of the sponsor's last update on 19 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal Pro-Inflammatory Gene Expression (time frame: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention). The study lists 6 primary outcomes in all. 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 19 May 2026.