Clinical trial NCT05012072: Reducing Pregnancy Risks: The Mastery Lifestyle Intervention
Official title: Reductions in Biopsychosocial Risks for Pregnant Minority Women and Their Infants: The Mastery Lifestyle Intervention (MLI)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health Wellness 1
Preterm Birth
Keywords: Latina
Pregnancy
Mental Health
Corticotropin Releasing Hormone
Progesterone
Estriol
Gestational age
African American women
Lead sponsor: Microgen LLC
Sponsor class: INDUSTRY
First posted: 2021-08-19
Enrollment: 238
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Usual care group: routine prenatal care by private practice provider Experimental group: Six week group session of the MLI
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Anxiety
timeFrame: Assessing change over time: 14-20 weeks, 21-27 weeks, 32-36 weeks pregnant
measure: Depression
timeFrame: Assessing change over time:14-20 weeks, 21-27 weeks, 32-36 weeks pregnant
measure: Stress
timeFrame: Assessing change over time:14-20 weeks, 21-27 weeks, 32-36 weeks pregnant
measure: Coping levels
timeFrame: Assessing change over time:14-20 weeks, 21-27 weeks, 32-36 weeks pregnant
Secondary outcomes:
measure: 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.
timeFrame: Assessing change over time:14-20 weeks gestation, 21-27 weeks gestation
measure: 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.
timeFrame: Assessing change over time:14-20 weeks gestation, 21-27 weeks gestation
measure: To explore the effect of the MLI, versus a usual care group, on the neuroendocrine risk factor of Estriol.
timeFrame: Assessing change over time:14-20 weeks gestation, 21-27 weeks gestation
Other outcomes:
measure: To explore the effect of the MLI on infant gestational age at birth
timeFrame: After delivery
measure: To explore the effect of the MLI on infant birthweight
timeFrame: After Delivery
measure: To explore the effect of the MLI on infants being admitted to the Neonatal Intensive Care Unit
timeFrame: After Delivery
Locations:
city: Houston
country: United States
facility: Anthony Chavez, MD
state: Texas
Study officials:
affiliation: Microgen Laboratories LLC
name: Roberta J Ruiz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.