Reducing Pregnancy Risks: The Mastery Lifestyle Intervention

Launched by MICROGEN LLC · Aug 11, 2021

Keywords

ClinConnect Summary

This clinical trial, called the Mastery Lifestyle Intervention (MLI), is studying how a special program can help pregnant women reduce the risks of giving birth prematurely. The researchers will work with 221 pregnant women who are between 14 to 20 weeks along in their pregnancy. These women will either participate in the MLI, which includes six group sessions focused on mental health and wellness, or they will receive standard prenatal care. The study aims to see how this program affects not only the women's mental health but also their hormone levels and their babies' health at delivery.

To be eligible for this trial, women need to be between 18 and 45 years old, be pregnant with one baby, and identify as Latina of Mexican heritage or African American. They also need to be able to read and speak either English or Spanish and show signs of stress or anxiety through simple questionnaires. Participants can expect to either join the MLI sessions or continue with regular prenatal care, and the researchers will monitor their health and their babies' health throughout the study. This trial is important because it could provide valuable information on how lifestyle changes can improve outcomes for pregnant women and their babies.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• 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
• Women who develop GDM after enrollment in the study will remain in the study. Development of hypertension or preeclampsia, pyelonephritis, or GDM will be considered an effect modifier in analysis of infant outcomes. Current antidepressant use will not be exclusionary and will also be used as an effect modifier. Further rationale for the exclusion criteria is:
• • 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