Reducing Pregnancy Risks: The Mastery Lifestyle Intervention

NCT05012072 | Recruiting DMC

• 1 other identifier: 1
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mental Health Wellness 1; Preterm Birth

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Anxiety

  Self Report questionnaire GAD-7

  Assessing change over time: 14-20 weeks, 21-27 weeks, 32-36 weeks pregnant

• Depression

  Self Report questionnaire CES-D

  Assessing change over time:14-20 weeks, 21-27 weeks, 32-36 weeks pregnant

• Stress

  Self Report questionnaire-PSS

  Assessing change over time:14-20 weeks, 21-27 weeks, 32-36 weeks pregnant

• Coping levels

  Self Report questionnaire The Brief Cope

  Assessing change over time:14-20 weeks, 21-27 weeks, 32-36 weeks pregnant

Secondary Outcomes (3)

• 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.

  Assessing change over time:14-20 weeks gestation, 21-27 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.

  Assessing change over time:14-20 weeks gestation, 21-27 weeks gestation

• To explore the effect of the MLI, versus a usual care group, on the neuroendocrine risk factor of Estriol.

  Assessing change over time:14-20 weeks gestation, 21-27 weeks gestation

Other Outcomes (3)

• To explore the effect of the MLI on infant gestational age at birth

  After delivery

• To explore the effect of the MLI on infant birthweight

  After Delivery

• To explore the effect of the MLI on infants being admitted to the Neonatal Intensive Care Unit

  After Delivery

Study Arms (2)

MLI Experimental group

EXPERIMENTAL

6 group sessions over 6 weeks with pregnant Latinas and African Americans starting at 14-20 weeks to 21-27 weeks in their prenatal care setting.

Behavioral: The Mastery Lifestyle Intervention

Control usual prenatal care

NO INTERVENTION

Only data collection but no intervention

Interventions

The Mastery Lifestyle Intervention BEHAVIORAL

Combination cognitive behavioral intervention of phase 3 CBT using ACT and PST

MLI Experimental group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant Female between 14 to 20 weeks at the time of enrollment.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Providing informed consent;
• Ability to read and speak English
• Pregnant at 14-20 weeks gestation with one fetus, intrauterine pregnancy, gestational dating will be reviewed before enrollment via ultrasound administered per standard of care
• Self-identification as African American or Hispanics
• Age 18 to 45 years
• Currently living in the U.S.; Women who identify as just getting along, nearly poor, or poor upon prescreen.
• 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

You may not qualify if:

• After initial review of the electronic health record (EHR):
• Major systemic infections such as HIV, hepatitis
• \<18 years of age or \>45 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
• Only singleton pregnancies are included as the mechanisms of PTB are thought to differ with multiples.
• We do not exclude participants based on language (English or Spanish) spoken. We expect heterogeneity in language spoken and expect that there may be women who use both languages. Our prior study findings indicate that the risk of PTB is greatest among English-speaking and bilingual women, although we believe that all women will receive benefit from the MLI.
• Girls \<18 are excluded as the intervention is designed to improve emotional wellbeing and quality of life in mature adults; girls \<18 may not be cognitively ready for the adult intervention and may need an intervention tailored to their stage of development. Girls under 18 also have a different set of risks than women over 18 years of age.
• We will control the use of progesterone treatment statistically.
• Women who develop gestational diabetes after enrolling in the study will remain in the study.
• At enrollment or during the study, anyone who is prescribed antidepressant or anti-anxiety medications will be eligible for the study. We will make note of it and control it in analysis. If a participant is referred for individual therapy, we will obtain data from the prenatal record and control for that in the analysis

Sponsors & Collaborators

• Microgen LLC: lead
• University of Houston: collaborator

Study Sites (1)

Women's Specialist of PLLC

Webster, Texas, 77598, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 36577949 BACKGROUND

• 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.

  PMID: 31693556 RESULT

Related Links

• PubMed

MeSH Terms

Conditions

Premature Birth; Psychological Well-Being

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Personal Satisfaction; Behavior

Study Officials

• Roberta J Ruiz, PhD

  University of Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberta J. Ruiz, PhD

CONTACT

2813005265; raruiz20@central.uh.edu

Kathryn Tart, EdD, MSN, RN

CONTACT

kmtart@Central.UH.EDU

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The PI will not be allowed to review any data that is not deidentified. The statistician will also not know which participant is in which group by participant names, only by deidentified data. The clinical outcomes assessor will not know the group the participant has been in or their study number, but will know the participant names to be able to put the clinical outcomes in the database.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor

Model Details: Usual care group: routine prenatal care by private practice provider Experimental group: Six week group session of the MLI

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 19, 2021
• Study Start: August 1, 2021
• Primary Completion: March 9, 2026
• Study Completion: April 13, 2026
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)