Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Houston | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control usual prenatal care | No Intervention | Only data collection but no intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Mastery Lifestyle Intervention | Behavioral | Combination cognitive behavioral intervention of phase 3 CBT using ACT and PST |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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, 21-27 weeks gestation |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
After initial review of the electronic health record (EHR):
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. Current antidepressant use will not be exclusionary and will also be used as an effect modifier. Further rationale for the exclusion criteria is:
Pregnant Female between 14 to 20 weeks at the time of enrollment.
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roberta J. Ruiz, PhD | Contact | 2813005265 | raruiz20@central.uh.edu | |
| Kathryn Tart, EdD, MSN, RN | Contact | 8328428218 | kmtart@Central.UH.EDU |
| Name | Affiliation | Role |
|---|---|---|
| Roberta J Ruiz, PhD | University of Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's Specialist of PLLC | Recruiting | Webster | Texas | 77598 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36577949 | Background | 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. | |
| 31693556 |
| Label | URL |
|---|---|
| PubMed | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Sep 16, 2024 | Jan 15, 2025 | Prot_SAP_ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
Usual care group: routine prenatal care by private practice provider Experimental group: Six week group session of the MLI
Not provided
Not provided
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.
| 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, 21-27 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, 21-27 weeks gestation |
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 |
| Result |
| 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. |
| D000091642 | Urogenital Diseases |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |