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Completed

NCT Number: NCT06898658

Conscious Pregnancy: Supporting Maternal Cardiometabolic Health With Mindfulness

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.

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Key information

Conditions

Maternal Cardiometabolic Health Behavior Behavioral Symptoms Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Financial Stress Glucose Metabolism Disorders Maternal Behavior Maternal Diabetes Maternal Distress Maternal Inflammatory Markers Metabolic Diseases Molecular Impact of Psychological Stress and Socioeconomic Adversity Nutritional and Metabolic Diseases Pregnancy Complications Stress, Psychological Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

MOMS

Santa Ana, California, 92703, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Having regular mindfulness practice
  • T1 or T2D diagnosis

Treatment and study plan

Mindfulness Intervention

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. Perceived Stress Scale (PSS)

    Time frame: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention

    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).

  2. Edinburgh Postnatal Depression Scale (EPDS)

    Time frame: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention

    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).

  3. Five Facet Mindfulness Questionnaire (FFMQ)

    Time frame: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention

    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).

  4. Pregnancy-related anxiety (PRAQ-R2)

    Time frame: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention

    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).

  5. State-Trait Anxiety Inventory (STAI)

    Time frame: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention

    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).

  6. Spot Morning Cortisol Sample

    Time frame: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention

    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.

  7. Homocysteine

    Time frame: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention

    Homocysteine will be measured via DBS and reported in umol/L units. Higher homocysteine levels are linked to increased inflammation.

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

Mindfulness and Cardiometabolic Health for Spanish Speaking Latina Pregnant Women: A Community-informed Project Targeting Inflammatory Gene Expression and Glycemic Control

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Mar 27, 2025
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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