Summary

Eligibility
for females ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UC Irvine
Dates
study started
completion around
Principal Investigator
by Lauren E Gyllenhammer, PhD (uci)Karen L Lindsay, RD, PhD (uci)

Description

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.

Official Title

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

Details

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.

Keywords

Maternal Cardiometabolic Health, Molecular Impact of Psychological Stress and Socioeconomic Adversity, Maternal Inflammatory Markers, Maternal Diabetes, Maternal Behavior, Maternal Distress, Gestational Diabetes, Psychological Stress, Mindfulness Intervention

Eligibility

You can join if…

Open to females ages 18 years and up

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

You CAN'T join if...

  1. Having regular mindfulness practice
  2. T1 or T2D diagnosis

Location

  • MOMS
    Santa Ana California 92703 United States

Lead Scientists at University of California Health

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Irvine
ID
NCT06898658
Study Type
Interventional
Participants
Expecting 60 study participants
Last Updated