Reducing Pregnancy Risks: The Mastery Lifestyle Intervention (MLI)

Reductions in Biopsychosocial Risks for Pregnant Latinas and Their Infants: The Mastery Lifestyle Intervention

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 221 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.

Study Overview

• Status: Recruiting
• Conditions: Preterm Birth; Mental Health Wellness 1
• Intervention / Treatment: Behavioral: The Mastery Lifestyle Intervention

Detailed Description

To address the gaps related to interventions for Hispanic Mexican American and African American pregnant women, the investigators have developed and successfully pilot tested the Mastery Lifestyle Intervention (MLI): a culturally-relevant, manualized psychosocial group intervention that integrates two evidence-based behavioral therapies - Acceptance and Commitment Therapy (ACT) and Problem-Solving Therapy (PST). The MLI is a 6-week program designed to be integrated into regular prenatal care to facilitate more comprehensive care delivered by a nurse practitioner (NP) or certified nurse midwife (CNM). We propose the following hypotheses for a randomized controlled trial: Hypothesis 1a: Participants in the 6-week MLI will have decreased depressive symptoms, anxiety, stress, disengaged coping, and increased active coping compared to UC at end-of-treatment and after 6 weeks. Hypothesis 1b: The effects of MLI versus UC on depression, anxiety, stress, acculturative stress, and coping will be mediated via psychological flexibility and moderated by acculturation. Hypothesis 2a: Compared to UC, MLI participants will have significantly lower mean levels of CRH over time from baseline to end-of-treatment. Hypothesis 2b: Compared to UC, MLI participants will have significantly higher progesterone levels and lower estriol levels (higher progesterone/estriol ratios) over time from baseline to end-of-treatment. Hypothesis 3: As compared to UC, infants from mothers in the MLI group will have longer gestational age, greater birth weight, and fewer NICU admissions.

• Study Type: Interventional
• Enrollment (Estimated): 221
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Roberta J. Ruiz, PhD; Phone Number: 2813005265; Email: jruiz@microgenlabs.com
• Study Contact Backup: Name: Raymond P Stowe, PhD; Phone Number: 2814154073; Email: rpstowe@microgenlabs.com

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77054
      • Recruiting
      • Anthony Chavez, MD
      • Contact: Roberta J Ruiz, PhD; Phone Number: 281-300-5265; Email: jruiz@microgenlabs.com
      • Contact: Raymond P Stowe, PhD; Phone Number: 12814154073; Email: rpstowe@microgenlabs.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion 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.

Exclusion Criteria:

After initial review of the electronic health record (EHR):

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MLI Experimental group; 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.	Behavioral: The Mastery Lifestyle Intervention; Combination cognitive behavioral intervention of phase 3 CBT using ACT and PST
No Intervention: Control usual prenatal care; Only data collection but no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	Self Report questionnaire GAD-7	Assessing change over time: 14-20 weeks, 20-26 weeks, 32-36 weeks pregnant
Depression	Self Report questionnaire CES-D	Assessing change over time:14-20 weeks, 20-26 weeks, 32-36 weeks pregnant
Stress	Self Report questionnaire-PSS	Assessing change over time:14-20 weeks, 20-26 weeks, 32-36 weeks pregnant
Coping levels	Self Report questionnaire The Brief Cope	Assessing change over time:14-20 weeks, 20-26 weeks, 32-36 weeks pregnant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Corticotropin Releasing Hormone is part of the maternal fetal responses to stress, anxiety, and depressive symptoms.	Assessing change over time:14-20 weeks gestation, 20-26 weeks gestation
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.	Progesterone is part of the maternal fetal responses to stress, anxiety, and depressive symptoms.	Assessing change over time:14-20 weeks gestation, 20-26 weeks gestation
To explore the effect of the MLI, versus a usual care group, on the neuroendocrine risk factor of Estriol.	Estriol is part of the maternal fetal response to stress, anxiety, and depressive symptoms.	Assessing change over time:14-20 weeks gestation, 20-26 weeks gestation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To explore the effect of the MLI on infant gestational age at birth	Health outcomes of the infants after usual care or after treatment with the intervention to further determine efficacy.	After delivery
To explore the effect of the MLI on infant birthweight	Health outcomes of the infants after usual care or after treatment with the intervention to further determine efficacy.	After Delivery
To explore the effect of the MLI on infants being admitted to the Neonatal Intensive Care Unit	Health outcomes of the infants after usual care or after treatment with the intervention to further determine efficacy.	After Delivery

Collaborators and Investigators

• Sponsor: Microgen LLC
• Investigators: Principal Investigator: Roberta J Ruiz, PhD, Microgen Laboratories LLC

Publications and helpful links

General Publications

• Ruiz RJ, Grimes K, Spurlock E, Stotts A, Northrup TF, Villarreal Y, Suchting R, Cernuch M, Rivera L, Stowe RP, Pickler RH. The mastery lifestyle intervention to reduce biopsychosocial risks for pregnant Latinas and African Americans and their infants: protocol for a randomized controlled trial. BMC Pregnancy Childbirth. 2022 Dec 28;22(1):979. doi: 10.1186/s12884-022-05284-9.
• Ruiz RJ, Newman M, Records K, Wommack JC, Stowe RP, Pasillas RM. Pilot Study of the Mastery Lifestyle Intervention. Nurs Res. 2019 Nov/Dec;68(6):494-500. doi: 10.1097/NNR.0000000000000384.

Helpful Links

• PubMed

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Estimated): December 20, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: July 27, 2021
• First Submitted That Met QC Criteria: August 11, 2021
• First Posted (Actual): August 19, 2021

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Mental Health; Pregnancy; Progesterone; Latina; Gestational age; African American women; Corticotropin Releasing Hormone; Estriol
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No