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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after delivery
Awards & highlights
MLI Trial 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.Check my eligibility
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.See study design
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.
MLI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 45 years old.
Select...
I can read and speak English or Spanish.
MLI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessing change over time:14-20 weeks, 20-26 weeks, 32-36 weeks pregnant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessing change over time:14-20 weeks, 20-26 weeks, 32-36 weeks pregnant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Anxiety
Coping levels
Depression
+1 moreSecondary outcome measures
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 outcome measures
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
MLI 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have major infections like HIV or hepatitis.I am under 18 years old.I am willing to follow the prescribed treatment plan.Women who have high levels of depression, anxiety, or stress based on questionnaires administered by the clinical staff.I am between 18 and 45 years old.You identify yourself as a person of Mexican or African American heritage.I can read and speak English or Spanish.
Research Study Groups:
This trial has the following groups:- Group 1: Control usual prenatal care
- Group 2: MLI Experimental group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are younger participants below the age of forty eligible for this experiment?
"This research project is seeking out individuals who are of 18 years or more, but not yet 45."
Answered by AI
Would I qualify for participation in this trial?
"Applicants to this medical experiment must have experienced premature births, and lie between the age range of 18-45. At present, 221 participants are being admitted into this trial."
Answered by AI
How many participants are currently involved in this research endeavor?
"Affirmative. Clinicaltrials.gov contains proof that this medical study, first advertised on July 23rd 2021, is still searching for participants. It requires 221 people from 1 location to join the trial."
Answered by AI
Are more participants being accepted for this clinical experiment?
"Affirmative. According to clinicaltrials.gov, this medical research initiative is at present recruiting participants which was originally posted on July 23rd 2021 and last updated April 6th 2022. 221 patients must be enlisted from a single location."
Answered by AI
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