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

Preterm Birth Mental Health Wellness 1

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

Inclusion Criteria8

Providing informed consent;
Ability to read and speak English
Pregnant at 14-20 weeks gestation with one fetus, intrauterine pregnancy, gestational dating will be reviewed before enrollment via ultrasound administered per standard of care
Self-identification as African American or Hispanics
Age 18 to 45 years
Currently living in the U.S.; Women who identify as just getting along, nearly poor, or poor upon prescreen.
Women who score 10 or greater on the Center for Epidemiological Studies Depression Scale (CES-D) OR 5 or greater on the Generalized Anxiety Disorder-7 scale (GAD-7), or 14 or > on the Perceived Stress Scale as administered by clinical staff of the participating provider
Willingness to adhere to the MLI regimen or usual care regimen

Exclusion Criteria12

After initial review of the electronic health record (EHR):
Major systemic infections such as HIV, hepatitis
<18 years of age or >45 years of age
Enrollment in a prenatal program such as the Nurse Family Partnership
Severe cognitive or psychiatric impairment per judgment of providers, that precludes cooperation with study protocol
Inability to read English
Only singleton pregnancies are included as the mechanisms of PTB are thought to differ with multiples.
We do not exclude participants based on language (English or Spanish) spoken. We expect heterogeneity in language spoken and expect that there may be women who use both languages. Our prior study findings indicate that the risk of PTB is greatest among English-speaking and bilingual women, although we believe that all women will receive benefit from the MLI.
Girls <18 are excluded as the intervention is designed to improve emotional wellbeing and quality of life in mature adults; girls <18 may not be cognitively ready for the adult intervention and may need an intervention tailored to their stage of development. Girls under 18 also have a different set of risks than women over 18 years of age.
We will control the use of progesterone treatment statistically.
Women who develop gestational diabetes after enrolling in the study will remain in the study.
At enrollment or during the study, anyone who is prescribed antidepressant or anti-anxiety medications will be eligible for the study. We will make note of it and control it in analysis. If a participant is referred for individual therapy, we will obtain data from the prenatal record and control for that in the analysis