The Mastery Lifestyle Intervention for Premature Births

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Anthony Chavez, MD, Houston, TX
Premature Births+2 More
The Mastery Lifestyle Intervention - Behavioral
Eligibility
18 - 65
Female
Eligible conditions
Select

Study Summary

This study is evaluating whether a psychoeducational intervention can reduce the risk of preterm birth.

See full description

Eligible Conditions

  • Premature Births
  • Mental Health Wellness 1

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether The Mastery Lifestyle Intervention will improve 4 primary outcomes, 3 secondary outcomes, and 3 other outcomes in patients with Premature Births. Measurement will happen over the course of Assessing change over time: 14-20 weeks, 20-26 weeks, 32-36 weeks pregnant.

After Delivery
To explore the effect of the MLI on infant birthweight
To explore the effect of the MLI on infants being admitted to the Neonatal Intensive Care Unit
After delivery
To explore the effect of the MLI on infant gestational age at birth
Week 36
Anxiety
Week 26
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.
Week 36
Coping levels
Depression
Stress

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control usual prenatal care
1 of 2
MLI Experimental group
1 of 2
Active Control
Experimental Treatment

This trial requires 221 total participants across 2 different treatment groups

This trial involves 2 different treatments. The Mastery Lifestyle Intervention is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

MLI Experimental group
Behavioral
6 group sessions over 6 weeks with pregnant Latinas starting at 14-20 weeks to 20-26 weeks in their prenatal care setting.
Control usual prenatal careOnly data collection but no intervention

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: after delivery
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly after delivery for reporting.

Who is running the study

Principal Investigator
R. J. R.
Roberta Jeanne Ruiz, Principal Health Care Scientist
Microgen LLC

Closest Location

Anthony Chavez, MD - Houston, TX

Eligibility Criteria

This trial is for female patients between 18 and 65 years old. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
, OR 2 or greater on the Patient Health Questionnaire-8 (PHQ-8) during their current pregnancy OR have a history of major depression or anxiety disorder, are considered at-risk for prenatal depression show original
Providing informed consent;
The ability to speak or read English and Spanish is a requirement for this job. show original
Pregnant at 14-20 weeks gestation with one fetus, gestational dating will be reviewed before enrollment via ultrasound administered per standard of care
is a pregnancy that is located in the uterus show original
I identify as a Latina woman of Mexican heritage show original
Age 18 to 45 years
A person born in either Mexico or the United States and who is currently living in the United States. show original
programs Governments support insurance programs that help people pay for health care show original
Willingness to adhere to the MLI regimen or usual care regimen

Patient Q&A Section

How many people get premature birth a year in the United States?

"The number of Americans with a single birth prematurely has declined markedly during the past 30 years; however, it still is at a high level. The percentage of the population with a single birth that is prematurely has tripled. A major public health problem exists, and prevention measures are urgently needed and should be given top priority." - Anonymous Online Contributor

Unverified Answer

What are the signs of premature birth?

"In order to reduce adverse maternal and neonatal outcomes associated with premature birth, we need to identify strategies and interventions that target preterm fetal growth." - Anonymous Online Contributor

Unverified Answer

Can premature birth be cured?

"Premature birth can be prevented in the first 33 weeks of gestation by improving nutrition and improving the general status of the mother. This can reduce the incidence and death from prematurity." - Anonymous Online Contributor

Unverified Answer

What causes premature birth?

"Premature birth can be attributed to multiple possible causes. The most common reasons listed were smoking, age (greater than 39 years) or multiple pregnancies (more than 2). However the most important causes of premature birth are genetics, health of the pregnancy (disease, exposure to harmful substances and lack of adequate prenatal care) and socio-economic deprivation. However, these factors explain only half the variation. The other causes of premature birth are in need of further study." - Anonymous Online Contributor

Unverified Answer

What is premature birth?

"Premature birth (before 35 weeks of gestation) is a major health concern. There are many reasons for premature birth including fetal abnormalities. Abnormal growth of the head (macrosomia/microcephaly) and breathing problems are the most commonly identifiable neonatal manifestations. Neonates of this kind are at increased risk of sudden infant death syndrome, which is associated with developmental delay, respiratory infections, and sudden unexpected death. This condition is more common in those born to women under the age of 30.\n" - Anonymous Online Contributor

Unverified Answer

What are common treatments for premature birth?

"A neonatal intensive care unit may be suggested for babies with gestational age between 22 and 27 weeks; premature babies, in whom the mother is under twenty-five years of age and is of low socioeconomic standing, may benefit more from non-invasive treatments such as maternal or fetal massage." - Anonymous Online Contributor

Unverified Answer

How serious can premature birth be?

"Premature birth is a serious condition that occurs in 0.45-1.5 per 1000 births. As soon as a child is found to be premature, a team can take steps to help the child survive their early first weeks of life. Such steps might include medical, nursing, social and family, and other forms of care. There is no exact rate at which prematurity progresses from the first day of a pregnancy to the time of premature birth. Nevertheless, there are certain indications of the health problems that can result from premature birth." - Anonymous Online Contributor

Unverified Answer

What does the mastery lifestyle intervention usually treat?

"Findings from a recent study suggests that the common practice of providing clients with an 'intention to change' is not effective in reducing their unhealthy health behaviors. More comprehensive approaches are needed when aiming to change clients' behavior." - Anonymous Online Contributor

Unverified Answer

Does the mastery lifestyle intervention improve quality of life for those with premature birth?

"For those who do not demonstrate improvement from their baseline PROM at 3 months, an MLI is not likely to effectively improve HRQOL. However, for those who do demonstrate a significant improvement from 3 months to the termination of the MLI, the improvement in HRQOL persists post-MLI." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets premature birth?

"When comparing two studies with a different cut-off age from 30 weeks onward, we found a significant difference in mean gestational age at birth: 14.3 weeks for a Chinese study vs. 17.5 weeks for this study." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in the mastery lifestyle intervention for therapeutic use?

"[Focuses principally on a recent meta-analysis of clinical and pre-clinical studies published during 2006 to 2014.] The meta-analysis of clinical trial studies (published during 2006 to 2013) shows positive results of mastery lifestyle intervention on decreasing depressive symptoms, and on improving the cognitive, psychosocial adjustment, motivation to cope, and health-related quality of life. The meta-analysis of pre-clinical studies (published during 2004 to 2014) shows positive results of mastery lifestyle intervention on improving long-term memory. Results from a recent paper may contribute further to developing therapeutic modalities for patients with chronic non-cognitive depression." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating premature birth?

"There were many new treatments being studied and researched. There was a strong need and need for further research, to determine the best treatments to offer women and their families. Until further research tells us what is the most effective treatment, we should continue offering all treatments available. When we learn what may work best and in which circumstances, we should then work with patients to decide for themselves what treatment is best for them in their individual situation." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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