Maternal Behavior, Maternal Cardiometabolic Health, Maternal Diabetes, Maternal Distress, Maternal Inflammatory Markers, Molecular Impact of Psychological Stress and Socioeconomic Adversity
Conditions
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=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.
Interventions
BEHAVIORALMindfulness 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.
Sponsors
University of California, Irvine
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLauren E Gyllenhammer, PhD
University of California, Irvine
PRINCIPAL_INVESTIGATORKaren L Lindsay, RD, PhD
University of California, Irvine
Outcome results
None listed