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Mastery Lifestyle Intervention for Premature Birth (MLI Trial)

Phase 2
Recruiting
Led By Roberta J Ruiz, PhD
Research Sponsored by Microgen LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 to 45 years
Ability to read and speak English or Spanish
Must not have
Major systemic infections such as HIV, hepatitis
<18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after delivery
Awards & highlights

Summary

This trial will test an intervention to see if it can help reduce the risk of preterm birth in pregnant Hispanic women.

Who is the study for?
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.
What is being tested?
The Mastery Lifestyle Intervention (MLI) aims to reduce preterm birth risks through a psychoeducational program over six sessions compared to standard care. The study will measure hormone levels and infant outcomes at delivery among the participants.
What are the potential side effects?
Since MLI is a psychoeducational intervention rather than a drug treatment, side effects may include emotional discomfort due to discussions about personal experiences related to pregnancy but no physical side effects are expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 45 years old.
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I can read and speak English or Spanish.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have major infections like HIV or hepatitis.
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I am under 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessing change over time:14-20 weeks, 20-26 weeks, 32-36 weeks pregnant
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessing change over time:14-20 weeks, 20-26 weeks, 32-36 weeks pregnant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Anxiety
Coping levels
Depression
+1 more
Secondary study objectives
To explore the effect of the MLI, versus a usual care group, on neuroendocrine risk factors (progesterone) on preterm birth from baseline to end-of treatment.
To explore the effect of the MLI, versus a usual care group, on the neuroendocrine risk factor of Estriol.
To explore the effect of the MLI, versus a usual care group, on the neuroendocrine risk factor of preterm birth (Corticotropin Releasing Hormone (CRH).from baseline to end-of treatment.
Other study objectives
To explore the effect of the MLI on infant birthweight
To explore the effect of the MLI on infant gestational age at birth
To explore the effect of the MLI on infants being admitted to the Neonatal Intensive Care Unit

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: MLI Experimental groupExperimental Treatment1 Intervention
6 group sessions over 6 weeks with pregnant Latinas and African Americans starting at 14-20 weeks to 20-26 weeks in their prenatal care setting.
Group II: Control usual prenatal careActive Control1 Intervention
Only data collection but no intervention

Find a Location

Who is running the clinical trial?

Microgen LLCLead Sponsor
Roberta J Ruiz, PhDPrincipal InvestigatorMicrogen Laboratories LLC

Media Library

The Mastery Lifestyle Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05012072 — Phase 2
Premature Birth Research Study Groups: Control usual prenatal care, MLI Experimental group
Premature Birth Clinical Trial 2023: The Mastery Lifestyle Intervention Highlights & Side Effects. Trial Name: NCT05012072 — Phase 2
The Mastery Lifestyle Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05012072 — Phase 2
~64 spots leftby Dec 2025
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