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

Trial Summary

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 data supports the effectiveness of the treatment Mindfulness Intervention for gestational diabetes?

Research shows that mindfulness practices, like mindfulness-based stress reduction and mindfulness eating, can help lower blood sugar levels and reduce stress in women with gestational diabetes. These practices have been found to improve both physical and mental health outcomes in people with diabetes. ^{1 2 3 4 5}

Is mindfulness safe for pregnant women?

Research shows that mindfulness practices, like meditation and stress reduction techniques, are generally safe for pregnant women. Studies have found that these practices can help reduce stress and anxiety without harmful effects. ^{1 2 6 7 8}

How does the mindfulness treatment for gestational diabetes differ from other treatments?

The mindfulness treatment for gestational diabetes is unique because it focuses on reducing stress and anxiety, which are psychological factors that can affect blood sugar levels. Unlike traditional treatments that primarily involve diet, exercise, and insulin, this approach uses mindfulness practices to help manage stress, potentially improving both mental well-being and blood sugar control. ^{2 4 7 9 10}

What is the purpose of this trial?

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.

Research Team

Karen L Lindsay, RD, PhD

Principal Investigator

University of California, Irvine

Lauren E Gyllenhammer, PhD

Principal Investigator

University of California, Irvine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The effects of mindfulness eating and yoga exercise on blood sugar levels of pregnant women with gestational diabetes mellitus. [2022]

2. Brazil pubmed.ncbi.nlm.nih.gov

The Effect of Mindfulness-Based Stress Reduction Counseling on Blood Glucose and Perceived Stress in Women with Gestational Diabetes. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Emotional adjustment to diagnosis and intensified treatment of gestational diabetes. [2011]

4. United States 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. [2019]

5. Japan pubmed.ncbi.nlm.nih.gov

Effects of mindfulness-based intervention on glycemic control and psychological outcomes in people with diabetes: A systematic review and meta-analysis. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

GAP (gestational diabetes and pharmacotherapy) - study protocol for a randomized controlled, two-arm, single-site trial. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Randomised controlled pilot trial of mindfulness training for stress reduction during pregnancy. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

A Mindfulness Application for Reducing Prenatal Stress. [2022]

9. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Gestational diabetes mellitus: a review from 2004. [2022]

10. Scotland pubmed.ncbi.nlm.nih.gov

Psychosocial predictors of gestational weight gain and the role of mindfulness. [2018]