Mindfulness and Cardiometabolic Health for Spanish Speaking Latina Pregnant Women: A Community-informed Project Targeting Inflammatory Gene Expression and Glycemic Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Maternal Pro-Inflammatory Gene Expression
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton, intrauterine pregnancy
- •1st or 2nd trimester at enrollment
- •Fluent in Spanish
- •Self-identify as Hispanic/Latino
排除标准
- •Having regular mindfulness practice
- •T1 or T2D diagnosis
研究组 & 干预措施
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.
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.
干预措施: Mindfulness Intervention (Behavioral)
结局指标
主要结局
Maternal Pro-Inflammatory Gene Expression
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Perceived Stress Scale (PSS)(Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention)
- Edinburgh Postnatal Depression Scale (EPDS)(Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention)
- Five Facet Mindfulness Questionnaire (FFMQ)(Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention)
- Pregnancy-related anxiety (PRAQ-R2)(Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention)
- State-Trait Anxiety Inventory (STAI)(Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention)
- Spot Morning Cortisol Sample(Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention)
- Homocysteine(Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention)
研究者
Lauren Gyllenhammer
Assistant Professor
University of California, Irvine