Mastery Lifestyle Intervention for Premature Birth
(MLI Trial)
Trial Summary
What safety data exists for the Mastery Lifestyle Intervention for premature birth?
The provided research does not contain specific safety data for the Mastery Lifestyle Intervention (MLI) or any similar interventions under different names. The studies focus on various interventions for preterm infants, but none specifically mention MLI or provide safety data related to it.1
Is The Mastery Lifestyle Intervention a promising treatment for premature birth?
What is the purpose of 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.
Research Team
Roberta J Ruiz, PhD
Principal Investigator
Microgen Laboratories LLC
Eligibility Criteria
This trial is for pregnant women aged 18-45, of Mexican heritage or African American, with government insurance. They must be at 14-20 weeks gestation with one fetus and show signs of stress or anxiety. Excluded are those under 18, in certain prenatal programs, with severe cognitive issues, unable to read English/Spanish, or have major infections like HIV.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the Mastery Lifestyle Intervention (MLI) over 6 group sessions
Follow-up
Participants are monitored for changes in anxiety, depression, stress, and coping levels
Post-delivery Follow-up
Health outcomes of infants are assessed after delivery
Treatment Details
Interventions
- The Mastery Lifestyle Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Microgen LLC
Lead Sponsor