RecruitingNot ApplicableNCT05012072

Reducing Pregnancy Risks: The Mastery Lifestyle Intervention

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


Sponsor

Microgen LLC

Enrollment

238 participants

Start Date

Aug 1, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called The Mastery Lifestyle Intervention for people with mental health wellness 1 and preterm birth. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 18 Years to 45 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALThe 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

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NCT05012072


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