Conscious Pregnancy: Supporting Maternal Cardiometabolic Health With Mindfulness

NCT06898658 | Recruiting

• 2 other identifiers: 4967P50MD017344
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• Maternal Pro-Inflammatory Gene Expression

  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.

  Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention

• High Sensitivity C-Reactive Protein

  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.

  Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention

• Fasting Glucose

  Fasting glucose will be measured using a glucometer and reported in mg/dL.

  Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention

• Hemoglobin A1c (HbA1c)

  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.

  Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention

• Fasting Insulin

  Fasting insulin will be measured via DBS and reported in uIU/mL units.

  Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention

• Lipid Panel

  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.

  Comparison of intervention and control group will occur pre and post 6-week mindfulness intervention

Secondary Outcomes (7)

• 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

Other Outcomes (2)

• Acceptability of Continuous Glucose Monitoring (CGM)

  8 weeks (1 week of measurement prior to starting 6 week intervention, and 1 week measurement after intervention completion))

• Feasibility of CGM

  8 weeks (1 week of measurement prior to starting 6 week intervention, and 1 week measurement after intervention completion))

Study Arms (2)

Wait-List Control Group

NO INTERVENTION

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

EXPERIMENTAL

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.

Behavioral: Mindfulness Intervention

Interventions

Mindfulness Intervention 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.

Mindfulness Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Singleton, intrauterine pregnancy
• st or 2nd trimester at enrollment
• Fluent in Spanish
• Self-identify as Hispanic/Latino
• Low-income

You may not qualify if:

• Having regular mindfulness practice
• T1 or T2D diagnosis

Sponsors & Collaborators

• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• University of California, Irvine: lead

Study Sites (1)

MOMS

Santa Ana, California, 92703, United States

RECRUITING

MeSH Terms

Conditions

Financial Stress; Diabetes, Gestational

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Lauren E Gyllenhammer, PhD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

• Karen L Lindsay, RD, PhD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 27, 2025
• Study Start: March 27, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)