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RECRUITING
NCT05012072
NA

Reducing Pregnancy Risks: The Mastery Lifestyle Intervention

Sponsor: Microgen LLC

View on ClinicalTrials.gov

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

Interventions

BEHAVIORAL

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