Clinical trial NCT06898658: Conscious Pregnancy: Supporting Maternal Cardiometabolic Health With Mindfulness
Official title: Mindfulness and Cardiometabolic Health for Spanish Speaking Latina Pregnant Women: A Community-informed Project Targeting Inflammatory Gene Expression and Glycemic Control
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Maternal Cardiometabolic Health
Molecular Impact of Psychological Stress and Socioeconomic Adversity
Maternal Inflammatory Markers
Maternal Diabetes
Maternal Behavior
Maternal Distress
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2025-03-27
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maternal Pro-Inflammatory Gene Expression
timeFrame: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention
measure: High Sensitivity C-Reactive Protein
timeFrame: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention
measure: Fasting Glucose
timeFrame: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention
measure: Hemoglobin A1c (HbA1c)
timeFrame: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention
measure: Fasting Insulin
timeFrame: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention
measure: Lipid Panel
timeFrame: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention
Secondary outcomes:
measure: Perceived Stress Scale (PSS)
timeFrame: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention
measure: Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention
measure: Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention
measure: Pregnancy-related anxiety (PRAQ-R2)
timeFrame: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention
measure: Spot Morning Cortisol Sample
timeFrame: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention
measure: Homocysteine
timeFrame: Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention
Other outcomes:
measure: Acceptability of Continuous Glucose Monitoring (CGM)
timeFrame: 8 weeks (1 week of measurement prior to starting 6 week intervention, and 1 week measurement after intervention completion))
measure: Feasibility of CGM
timeFrame: 8 weeks (1 week of measurement prior to starting 6 week intervention, and 1 week measurement after intervention completion))
Locations:
city: Santa Ana
country: United States
facility: MOMS
state: California
Study officials:
affiliation: University of California, Irvine
name: Lauren E Gyllenhammer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Irvine
name: Karen L Lindsay, RD, PhD
role: PRINCIPAL_INVESTIGATOR
References: