RECRUITING

Reducing Pregnancy Risks: The Mastery Lifestyle Intervention

Conditions

Mental Health Wellness 1 Preterm Birth Latina Pregnancy Mental Health Corticotropin Releasing Hormone Progesterone Estriol Gestational age African American women

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Reductions in Biopsychosocial Risks for Pregnant Minority Women and Their Infants: The Mastery Lifestyle Intervention (MLI)

Quick Facts

Study Start:2021-08-01

Study Completion:2026-04-13

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05012072

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Providing informed consent; * Ability to read and speak English or Spanish * Pregnant at 14-20 weeks gestation with one fetus, gestational dating will be reviewed before enrollment via ultrasound administered per standard of care * Intrauterine pregnancy * Self-identification as Latina of Mexican heritage or African American * Age 18 to 45 years * Born in Mexico or U.S. born and currently living in the U.S. * Medicaid or other government supported insurance * Women who score 10 or greater on the Center for Epidemiological Studies Depression Scale (CES-D) OR 5 or greater on the Generalized Anxiety Disorder-7 scale (GAD-7), or 14 or \> on the Perceived Stress Scale as administered by clinical staff of the participating provider * Willingness to adhere to the MLI regimen or usual care regimen * Women who develop GDM after enrollment in the study will remain in the study. °Development of hypertension or preeclampsia, pyelonephritis, or GDM will be considered an effect modifier in analysis of infant outcomes.	* Major systemic infections such as HIV, hepatitis * \<18 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 * Inability to read English or Spanish

Inclusion Criteria

Exclusion Criteria

* Providing informed consent;
* Ability to read and speak English or Spanish
* Pregnant at 14-20 weeks gestation with one fetus, gestational dating will be reviewed before enrollment via ultrasound administered per standard of care
* Intrauterine pregnancy
* Self-identification as Latina of Mexican heritage or African American
* Age 18 to 45 years
* Born in Mexico or U.S. born and currently living in the U.S.
* Medicaid or other government supported insurance
* Women who score 10 or greater on the Center for Epidemiological Studies Depression Scale (CES-D) OR 5 or greater on the Generalized Anxiety Disorder-7 scale (GAD-7), or 14 or \> on the Perceived Stress Scale as administered by clinical staff of the participating provider
* Willingness to adhere to the MLI regimen or usual care regimen
* Women who develop GDM after enrollment in the study will remain in the study. °Development of hypertension or preeclampsia, pyelonephritis, or GDM will be considered an effect modifier in analysis of infant outcomes.

* Major systemic infections such as HIV, hepatitis
* \<18 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
* Inability to read English or Spanish

Contacts and Locations

Study Contact

Roberta J. Ruiz, PhD

CONTACT

2813005265

jruiz@microgenlabs.com

Raymond P Stowe, PhD

CONTACT

2814154073

rpstowe@microgenlabs.com

Principal Investigator

Roberta J Ruiz, PhD

PRINCIPAL_INVESTIGATOR

Microgen Laboratories LLC

Study Locations (Sites)

Anthony Chavez, MD

Houston, Texas, 77054

United States

Collaborators and Investigators

Sponsor: Microgen LLC

Roberta J Ruiz, PhD, PRINCIPAL_INVESTIGATOR, Microgen Laboratories LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-01

Study Completion Date2026-04-13

Study Record Updates

Study Start Date2021-08-01

Study Completion Date2026-04-13

Terms related to this study

Keywords Provided by Researchers

Latina
Pregnancy
Mental Health
Corticotropin Releasing Hormone
Progesterone
Estriol
Gestational age
African American women

Additional Relevant MeSH Terms

Mental Health Wellness 1
Preterm Birth