Conscious Pregnancy: Supporting Maternal Cardiometabolic Health With Mindfulness

NCT06898658 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-05-19

No results posted yet for this study

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.

Conditions

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

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

    collaborator NIH
  • University of California, Irvine

    lead OTHER

Principal Investigators

  • Lauren E Gyllenhammer, PhD · University of California, Irvine

  • Karen L Lindsay, RD, PhD · University of California, Irvine

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-27
Primary Completion
2025-08-01
Completion
2026-01-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06898658 on ClinicalTrials.gov