Reducing Pregnancy Risks: The Mastery Lifestyle Intervention

NCT ID: NCT05012072

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 238 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2026-04-13

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.

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.

Conditions

Mental Health Wellness 1; Preterm Birth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

MLI Experimental group

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.

Group Type: EXPERIMENTAL

The Mastery Lifestyle Intervention

Intervention Type: BEHAVIORAL

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

Control usual prenatal care

Only data collection but no intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

The Mastery Lifestyle Intervention

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Houston

OTHER

Sponsor Role: collaborator

Microgen LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Roberta Jeanne Ruiz

Research Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roberta J Ruiz, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Houston

Locations

Women's Specialist of PLLC

Webster, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Roberta J. Ruiz, PhD

Role: CONTACT

raruiz20@central.uh.edu

2813005265

Kathryn Tart, EdD, MSN, RN

Role: CONTACT

kmtart@Central.UH.EDU

Facility Contacts

Roberta J Ruiz, PhD

Role: primary

jruiz@microgenlabs.com

281-300-5265

Roberta J Ruiz, PhD

Role: backup

raruiz20@central.uh.edu

2813005265

References

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.

Reference Type: BACKGROUND

PMID: 36577949 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31693556 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Related Links

http://pubmed.ncbi.nlm.nih.gov/31693556/

PubMed

Other Identifiers

1

Identifier Type: -

Identifier Source: org_study_id