Conscious Pregnancy: Supporting Maternal Cardiometabolic Health With Mindfulness

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.

Study Overview

• Status: Completed
• Conditions: Maternal Behavior; Maternal Distress; Maternal Diabetes; Maternal Cardiometabolic Health; Molecular Impact of Psychological Stress and Socioeconomic Adversity; Maternal Inflammatory Markers
• Intervention / Treatment: Behavioral: Mindfulness Intervention

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Ana, California, United States, 92703
      • MOMS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Singleton, intrauterine pregnancy
2. 1st or 2nd trimester at enrollment
3. Fluent in Spanish
4. Self-identify as Hispanic/Latino
5. Low-income

Exclusion Criteria:

1. Having regular mindfulness practice
2. T1 or T2D diagnosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Wait-List Control Group; 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.
Experimental: Mindfulness Intervention Group; 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.	Behavioral: Mindfulness Intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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).	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).	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.	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.	Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of Continuous Glucose Monitoring (CGM)	Masked upper arm continuous glucose monitoring (CGM) monitoring 1-week pre-post intervention will be assessed in a subsample (n=5 mindfulness group), using Dexcom G6. Acceptability of the 1-week GCM data will be determined by the post collection survey report of acceptability and number of adverse event reporting (e.g., skin irritation).	8 weeks (1 week of measurement prior to starting 6 week intervention, and 1 week measurement after intervention completion))
Feasibility of CGM	Feasibility of the 1-week GCM data will be determined by the enrollment rate (enrollment offered on a rolling basis to all mindfulness participants, enrollment rate will be calculated as number of invitations required to achieve consent in n=5), and number of days with complete data collection.	8 weeks (1 week of measurement prior to starting 6 week intervention, and 1 week measurement after intervention completion))

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Lauren E Gyllenhammer, PhD, University of California, Irvine; Principal Investigator: Karen L Lindsay, RD, PhD, University of California, Irvine

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2025
• Primary Completion (Actual): August 1, 2025
• Study Completion (Actual): January 30, 2026

Study Registration Dates

• First Submitted: March 19, 2025
• First Submitted That Met QC Criteria: March 25, 2025
• First Posted (Actual): March 27, 2025

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Pregnancy Complications; Behavioral Symptoms; Glucose Metabolism Disorders; Diabetes Mellitus; Stress, Psychological; Behavior; Nutritional and Metabolic Diseases; Financial Stress; Diabetes, Gestational
• Other Study ID Numbers: 4967; P50MD017344 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No