Reducing Pregnancy Risks: The Mastery Lifestyle Intervention

Recruiting now · Not applicable

Conditions studied: Mental Health Wellness 1, Preterm Birth

In brief

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.

Key facts

Study ID

NCT05012072

Run by

Microgen LLC

People needed

238

Starts

2021-08-01

Expected to finish

2026-04-13

Last updated by the study team

2025-07-17

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Women's Specialist of PLLC — Webster, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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