Conscious Pregnancy: Supporting Maternal Cardiometabolic Health With Mindfulness

Not Applicable

Recruiting

• Conditions: Maternal Cardiometabolic Health; Molecular Impact of Psychological Stress and Socioeconomic Adversity; Maternal Inflammatory Markers; Maternal Diabetes; Maternal Behavior; Maternal Distress

• Registration Number: NCT06898658
• Lead Sponsor: University of California, Irvine

Brief 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=60 (n=30 intervention, n=30 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=60; n=30 intervention, n=30 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. In addition, the investigators will examine the feasibility and acceptability of pre-post intervention continuous glucose monitoring (CGM) in n=5 mindfulness group participants.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-19
• Study First Submitted QC: 2025-03-25
• Study Start: 2025-03-27
• Study First Posted: 2025-03-27
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-11
• Primary Completion: 2026-07-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Maternal Pro-Inflammatory Gene Expression	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	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	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)	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	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	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 Outcome Measures

Name	Time	Method
Perceived Stress Scale (PSS)	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).
Edinburgh Postnatal Depression Scale (EPDS)	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).
Five Facet Mindfulness Questionnaire (FFMQ)	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).
Pregnancy-related anxiety (PRAQ-R2)	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).
State-Trait Anxiety Inventory (STAI)	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).
Spot Morning Cortisol Sample	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.
Homocysteine	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.

Trial Locations

Locations (1)

MOMS; 🇺🇸 Santa Ana, California, United States