Reducing Pregnancy Risks: The Mastery Lifestyle Intervention

Description

This randomized controlled trial will test an intervention called the Mastery Lifestyle Intervention (the MLI) that was developed from data of 1000+pregnant Hispanic women related to risks of preterm birth. The investigators will deliver a psychoeducational intervention that is manualized over 6 group sessions. The investigators will also have a usual care group that receives standard prenatal care. The investigators plan to enroll 238 pregnant women and start the study with them at 14-20 weeks gestation. The investigators will also test the biological response of the intervention by measuring Corticotropin Releasing Hormone, progesterone, estriol, and test for cotinine. The investigators will also determine any effect on infant outcomes at delivery.

Conditions

Mental Health Wellness 1, Preterm Birth

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Study Overview

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Study Details

Study overview

This randomized controlled trial will test an intervention called the Mastery Lifestyle Intervention (the MLI) that was developed from data of 1000+pregnant Hispanic women related to risks of preterm birth. The investigators will deliver a psychoeducational intervention that is manualized over 6 group sessions. The investigators will also have a usual care group that receives standard prenatal care. The investigators plan to enroll 238 pregnant women and start the study with them at 14-20 weeks gestation. The investigators will also test the biological response of the intervention by measuring Corticotropin Releasing Hormone, progesterone, estriol, and test for cotinine. The investigators will also determine any effect on infant outcomes at delivery.

Reductions in Biopsychosocial Risks for Pregnant Minority Women and Their Infants: The Mastery Lifestyle Intervention (MLI)

Reducing Pregnancy Risks: The Mastery Lifestyle Intervention

Condition
Mental Health Wellness 1
Intervention / Treatment

-

Contacts and Locations

Houston

Anthony Chavez, MD, Houston, Texas, United States, 77054

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Providing informed consent;
  • * Ability to read and speak English or Spanish
  • * Pregnant at 14-20 weeks gestation with one fetus, gestational dating will be reviewed before enrollment via ultrasound administered per standard of care
  • * Intrauterine pregnancy
  • * Self-identification as Latina of Mexican heritage or African American
  • * Age 18 to 45 years
  • * Born in Mexico or U.S. born and currently living in the U.S.
  • * Medicaid or other government supported insurance
  • * 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
  • * 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.
  • * Major systemic infections such as HIV, hepatitis
  • * \<18 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 or Spanish

Ages Eligible for Study

18 Years to 45 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Microgen LLC,

Roberta J Ruiz, PhD, PRINCIPAL_INVESTIGATOR, Microgen Laboratories LLC

Study Record Dates

2026-04-13