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Reducing Pregnancy Risks: The Mastery Lifestyle Intervention
Sponsor: Microgen LLC
Summary
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.
Official title: Reductions in Biopsychosocial Risks for Pregnant Latina Women and Their Infants: The Mastery Lifestyle Intervention (MLI)
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
238
Start Date
2021-08-01
Completion Date
2026-04-13
Last Updated
2025-07-17
Healthy Volunteers
No
Conditions
Interventions
The Mastery Lifestyle Intervention
Combination cognitive behavioral intervention of phase 3 CBT using ACT and PST
Locations (1)
Women's Specialist of PLLC
Webster, Texas, United States