Conscious Pregnancy: Supporting Maternal Cardiometabolic Health With Mindfulness

NCT ID: NCT06898658

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-27
• Study Completion Date: 2026-12-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Mindfulness Intervention

Intervention Type: BEHAVIORAL

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.

Interventions

Mindfulness 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Lauren Gyllenhammer

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lauren E Gyllenhammer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Karen L Lindsay, RD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

MOMS

Santa Ana, California, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Sarah O'Rourke, Chief Program Officer, MSW, MSPH

Role: primary

sorourke@momsorangecounty.org

714-352-3420

Other Identifiers

P50MD017344

Identifier Type: NIH

Identifier Source: secondary_id

View Link

4967

Identifier Type: -

Identifier Source: org_study_id