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Reducing Pregnancy Risks: The Mastery Lifestyle Intervention

NCT05012072 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 238

Last updated 2025-07-17

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

The Mastery Lifestyle Intervention

Combination cognitive behavioral intervention of phase 3 CBT using ACT and PST

Sponsors & Collaborators

  • University of Houston

    collaborator OTHER

  • Microgen LLC

    lead INDUSTRY

Principal Investigators

  • Roberta J Ruiz, PhD · University of Houston

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-01
Primary Completion
2026-03-09
Completion
2026-04-13

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05012072 on ClinicalTrials.gov