Reducing Pregnancy Risks: The Mastery Lifestyle Intervention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorMicrogen LLC
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- The Mastery Lifestyle Intervention
Treatment groups
238 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov