A program to reduce pregnancy risks for Latina and African American women
Reductions in Biopsychosocial Risks for Pregnant Latina Women and Their Infants: The Mastery Lifestyle Intervention (MLI)
This study is testing a new program to help pregnant Latina and African American women improve their mental health and lower the risk of preterm birth through group sessions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 238 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Microgen LLC Industry-sponsored |
| Locations | 1 site (Webster, Texas) |
| Trial ID | NCT05012072 on ClinicalTrials.gov |
What this trial studies
This clinical trial tests the Mastery Lifestyle Intervention (MLI), a culturally-relevant psychoeducational program designed for pregnant Hispanic and African American women at 14-20 weeks gestation. The MLI consists of six group sessions that integrate Acceptance and Commitment Therapy and Problem-Solving Therapy to improve mental health and reduce risks of preterm birth. Participants will be compared to a usual care group receiving standard prenatal care, and biological responses will be measured to assess the intervention's effectiveness. The study aims to enroll 238 women and evaluate both psychological and infant outcomes at delivery.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18-45, of Latina Mexican heritage or African American descent, who are at 14-20 weeks gestation and experiencing symptoms of depression or anxiety.
Not a fit: Patients who do not self-identify as Latina of Mexican heritage or African American, or those outside the specified age range, may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve mental health and reduce the risk of preterm birth in targeted populations.
How similar studies have performed: Other studies have shown success with culturally tailored interventions for similar populations, indicating potential for positive outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Providing informed consent; * Ability to read and speak English * Pregnant at 14-20 weeks gestation with one fetus, intrauterine pregnancy, gestational dating will be reviewed before enrollment via ultrasound administered per standard of care * Self-identification as African American or Hispanics * Age 18 to 45 years * Currently living in the U.S.; Women who identify as just getting along, nearly poor, or poor upon prescreen. * Women who score 10 or greater on the Center for Epidemiological Studies Depression Scale (CES-D) OR 5 or greater on the Generalized Anxiety Disorder-7 scale (GAD-7), or 14 or \> on the Perceived Stress Scale as administered by clinical staff of the participating provider * Willingness to adhere to the MLI regimen or usual care regimen Exclusion Criteria: After initial review of the electronic health record (EHR): * Major systemic infections such as HIV, hepatitis * \<18 years of age or \>45 years of age * Enrollment in a prenatal program such as the Nurse Family Partnership * Severe cognitive or psychiatric impairment per judgment of providers, that precludes cooperation with study protocol * Inability to read English Women who develop GDM after enrollment in the study will remain in the study. Development of hypertension or preeclampsia, pyelonephritis, or GDM will be considered an effect modifier in analysis of infant outcomes. Current antidepressant use will not be exclusionary and will also be used as an effect modifier. Further rationale for the exclusion criteria is: * Only singleton pregnancies are included as the mechanisms of PTB are thought to differ with multiples. * We do not exclude participants based on language (English or Spanish) spoken. We expect heterogeneity in language spoken and expect that there may be women who use both languages. Our prior study findings indicate that the risk of PTB is greatest among English-speaking and bilingual women, although we believe that all women will receive benefit from the MLI. * Girls \<18 are excluded as the intervention is designed to improve emotional wellbeing and quality of life in mature adults; girls \<18 may not be cognitively ready for the adult intervention and may need an intervention tailored to their stage of development. Girls under 18 also have a different set of risks than women over 18 years of age. * We will control the use of progesterone treatment statistically. * Women who develop gestational diabetes after enrolling in the study will remain in the study. * At enrollment or during the study, anyone who is prescribed antidepressant or anti-anxiety medications will be eligible for the study. We will make note of it and control it in analysis. If a participant is referred for individual therapy, we will obtain data from the prenatal record and control for that in the analysis
Where this trial is running
Webster, Texas
- Women's Specialist of PLLC — Webster, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Roberta J Ruiz, PhD — University of Houston
- Study coordinator: Roberta J. Ruiz, PhD
- Email: raruiz20@central.uh.edu
- Phone: 2813005265
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.