Mindfulness for Gestational Diabetes

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of California, Irvine

Disqualifiers: Regular mindfulness practice, T1 or T2D

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a mindfulness program can improve health markers related to blood sugar and inflammation in pregnant women. It targets Spanish-speaking Latina women who are low-income and in their first or second trimester. Participants will either join a mindfulness group or continue with their usual care, and researchers will then compare health results. Those already practicing mindfulness or diagnosed with type 1 or type 2 diabetes are not eligible. This study is specifically for women fluent in Spanish who identify as Hispanic/Latino. As an unphased trial, it offers a unique opportunity to contribute to research that could benefit future mothers in similar communities.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this mindfulness intervention is safe for pregnant women?

Research shows that mindfulness practices, such as the Mindfulness Awareness Practices (MAPs) under testing, are generally safe and manageable. In one study with 59 pregnant women, a mindfulness app significantly reduced stress, with an average drop of 6.3 points in stress levels. This suggests that mindfulness can effectively manage stress during pregnancy.

Moreover, MAPs, included in the mindfulness program, have been found to lessen intrusive thoughts and worry. Other studies have associated these practices with better heart and metabolic health. While these findings are encouraging, they primarily focus on participants' feelings and coping mechanisms, without revealing any major safety issues.

Overall, pregnant women have responded positively to mindfulness programs, which are considered safe. These practices aim to improve well-being without requiring intense physical activity, making them accessible to many people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the mindfulness intervention for gestational diabetes because it offers a unique, culturally tailored approach that is more accessible to diverse and socioeconomically disadvantaged populations. Unlike standard treatments for gestational diabetes, which typically involve dietary management, exercise, and sometimes medication, this mindfulness program focuses on enhancing mental well-being by teaching participants to pay attention to their experiences and emotions in a nonjudgmental way. The program's hybrid format, which adapts the proven Mindfulness Awareness Practices (MAPs) for pregnant women, eliminates the need for time-intensive activities like day-long retreats, making it easier to integrate into daily life. This approach could offer a holistic benefit by potentially reducing stress and improving overall maternal health during pregnancy.

What evidence suggests that this mindfulness intervention is effective for gestational diabetes?

Research has shown that mindfulness can help people with gestational diabetes. One study found that mindfulness techniques greatly reduced stress in pregnant women. Another study discovered that mindfulness-based counseling helped lower blood sugar levels. Additionally, women with gestational diabetes who practiced mindfulness experienced better health outcomes for themselves and their babies. In this trial, participants in the Mindfulness Intervention Group will engage in a culturally tailored mindfulness program. This suggests that mindfulness can be a helpful tool for managing gestational diabetes. ^{2 6 7 8 9}

Who Is on the Research Team?

Lauren E Gyllenhammer, PhD

Principal Investigator

University of California, Irvine

Karen L Lindsay, RD, PhD

Principal Investigator

University of California, Irvine

Are You a Good Fit for This Trial?

This trial is for low-income, Spanish-speaking Latina pregnant women who may be experiencing gestational diabetes, preeclampsia, or maternal distress. Participants should not have started any other intervention and must commit to the study's schedule.

Inclusion Criteria

Self-identify as Hispanic/Latino

I am fluent in Spanish.

Low-income

Exclusion Criteria

Having regular mindfulness practice

I have been diagnosed with Type 1 or Type 2 diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Mindfulness Intervention

Participants undergo a culturally tailored 6-week mindfulness intervention to improve cardiometabolic health

6 weeks

Hybrid format: live classes and digital at-home content

Follow-up

Participants are monitored for safety and effectiveness after the mindfulness intervention

4 weeks

Wait-List Control

Control group participants continue usual care and receive mindfulness materials post-intervention

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mindfulness Intervention

Trial Overview

The study tests a culturally tailored mindfulness program designed to improve fasting cardiometabolic factors and reduce inflammatory gene expression in participants compared to those on a wait-list control group.

How Is the Trial Designed?

Group I: Mindfulness Intervention Group Experimental Treatment 1 Intervention

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 II: Wait-List Control Group Active Control 1 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.

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

The study developed reliable and valid measures to assess psychosocial factors influencing physical activity and diet in women with a history of gestational diabetes mellitus (GDM), based on a survey of 160 participants.

These measures demonstrated good internal reliability and construct validity, which will help in evaluating behavior change interventions aimed at promoting healthy lifestyles in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reliability and Validity of Measures for Investigating the Determinants of Health Behaviors Among Women With a History of Gestational Diabetes. Smith, BJ., Cheung, NW., Najnin, N., et al.[2019]

A pilot study involving 59 pregnant patients showed that using a mindfulness app significantly reduced perceived stress levels by an average of 6.3 points between the second and third trimesters, compared to a historical control group.

Despite limited adherence to the app, the findings suggest that prenatal mindfulness practices could be a valuable nonpharmacologic intervention for managing stress during pregnancy, offering a low-cost and accessible option for expectant mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mindfulness Application for Reducing Prenatal Stress. Porter, AC., Hunter, S., Noonan, K., et al.[2022]

Citations

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pmc.ncbi.nlm.nih.gov

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The Effect of Mindfulness-Based Stress Reduction Counseling ...

The results of the present study showed that mindfulness-based stress reduction counseling is effective in reducing blood sugar levels and reducing perceived ...

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Mindfulness for Gestational Diabetes

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These findings suggest that mindfulness-based mobile app interventions may help improve mental well-being in pregnant women, potentially by ...

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pmc.ncbi.nlm.nih.gov

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uclahealth.org

uclahealth.org/programs/uclamindful/about-us/research/maps-research

Mindful Awareness Practices (MAPs) Research at MARC

MAPs statistically significantly decreased intrusive thoughts and worry at postintervention and 3-month follow-up relative to WLC (P < .027) and statistically ...

8.

link.springer.com

link.springer.com/article/10.1007/s12671-024-02337-2

Mindfulness and Cardiometabolic Health During Pregnancy

Mindfulness practices have been associated with improved cardiometabolic health in non-pregnant populations. The objective was to evaluate ...

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academic.oup.com/oodh/article/doi/10.1093/oodh/oqaf006/8088004

The effectiveness of mHealth mindfulness interventions on ...

This review systematically examines the effectiveness of mHealth MBIs in improving perinatal psychological outcomes, including stress, anxiety and depression.