Actively Recruiting
Reducing Pregnancy Risks: The Mastery Lifestyle Intervention
Led by Microgen LLC · Updated on 2025-07-17
238
Participants Needed
1
Research Sites
245 weeks
Total Duration
On this page
Sponsors
M
Microgen LLC
Lead Sponsor
U
University of Houston
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Reducing Pregnancy Risks: The Mastery Lifestyle Intervention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Providing informed consent
- Ability to read and speak English
- Pregnant at 14-20 weeks gestation with one fetus, confirmed by ultrasound
- Self-identify as African American or Hispanic
- Age between 18 and 45 years
- Currently living in the U.S. and identifying as just getting along, nearly poor, or poor
- Scoring 10 or higher on the Center for Epidemiological Studies Depression Scale (CES-D) OR 5 or higher on the Generalized Anxiety Disorder-7 scale (GAD-7), OR 14 or higher on the Perceived Stress Scale
- Willingness to follow the Mastery Lifestyle Intervention or usual care regimen
You will not qualify if you...
- Having major systemic infections such as HIV or hepatitis
- Being younger than 18 years or older than 45 years
- Enrollment in another prenatal program such as the Nurse Family Partnership
- Severe cognitive or psychiatric impairment that prevents cooperation with the study
- Inability to read English
AI-Screening
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Trial Site Locations
Total: 1 location
1
Women's Specialist of PLLC
Webster, Texas, United States, 77598
Actively Recruiting
Research Team
R
Roberta J. Ruiz, PhD
CONTACT
K
Kathryn Tart, EdD, MSN, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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