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Reductions in biopsychosocial risks for pregnant Latinas and their infants: the Mastery Lifestyle Intervention

Award Number: R01HD101535
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/14/2025
PERIOD OF PERFORMANCE END DATE: 02/28/2026

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Reductions in biopsychosocial risks for pregnant Latinas and their infants: the Mastery Lifestyle Intervention - Project Summary/Abstract Pregnant Mexican-American women (the largest subgroup of Hispanic women), hereafter referred to as Latinas, are at increasing risk for psychological distress which leads to adverse birth outcomes such as preterm birth (PTB, gestational age < 37 weeks) and low birthweight (LBW, <2500 grams). Our prior research, using a psychoneuroimmunology (PNI) framework, has identified psychological risk factors (depressive symptoms, anxiety, stress, coping) and neuroendocrine risk factors (high Corticotropin Releasing Hormone [CRH], lower progesterone, higher estriol) at 22-24 weeks gestation as strong predictors of PTB in Latina women. New interventions targeting these risk factors need to be identified and rigorously tested. To address the gaps related to interventions for Latinas, we 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 aims for a randomized controlled trial: Primary Aim 1: Determine the efficacy of the MLI in pregnant Latina women to decrease depressive symptoms, anxiety, perceived and acculturative stress, and to improve coping, versus usual care (UC), from baseline (14-20 weeks gestation) to end-of-treatment (20-26 weeks gestation) and at a 6 week follow-up (26-32 weeks gestation), with acculturation and psychological flexibility as mediators. Exploratory Aim 2: Explore the effect of the MLI on neuroendocrine risk factors of PTB (CRH, progesterone, and estriol) versus UC from baseline to end-of treatment. Exploratory Aim 3: Explore the effect of the MLI on infant birth outcomes (gestational age, birthweight, NICU admission). Analyses for each hypothesis will rely on generalized linear mixed modeling (GLMM) with random effects for participant and time as necessary to account for correlated observations. Longitudinal analyses will model each outcome as a function of treatment group, time, and the interaction between treatment group and time. We will also use SEM to analyze for mediators. We expect the MLI will provide a greatly needed, novel, feasible, and effective nonpharmacological program added to the toolbox of treatments assisting providers to improve health during pregnancy. Embedded into prenatal care, it targets psychological distress among pregnant Latina women, an underserved population. It may substantially reduce the risks for poor birth outcomes, thus reducing devastating and long-term effects for both mother and infant.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $1,009,482 )
2025	2025	MICROGEN LLC	903 TEXAS AVE	LA MARQUE	TX	77568	GALVESTON	USA	Child Health and Human Development Extramural Research	003	5	7/18/2025	NON-COMPETING CONTINUATION	-$122,402
2025	2025	UNIVERSITY OF HOUSTON SYSTEM	4300 MARTIN LUTHER KING BLVD	HOUSTON	TX	77204	HARRIS	USA	Child Health and Human Development Extramural Research	005	6	7/30/2025	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$504,741
2025	2025	MICROGEN LLC	903 TEXAS AVE	LA MARQUE	TX	77568	GALVESTON	USA	Child Health and Human Development Extramural Research	002	5	7/16/2025	NON-COMPETING CONTINUATION	-$480,621
2025	2025	MICROGEN LLC	903 TEXAS AVE	LA MARQUE	TX	77568	GALVESTON	USA	Child Health and Human Development Extramural Research	000	5	2/12/2025	NON-COMPETING CONTINUATION	$542,722
2025	2025	UNIVERSITY OF HOUSTON SYSTEM	4300 MARTIN LUTHER KING BLVD	HOUSTON	TX	77204	HARRIS	USA	Child Health and Human Development Extramural Research	004	6	7/30/2025	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$504,741
2025	2025	MICROGEN LLC	903 TEXAS AVE	LA MARQUE	TX	77568	GALVESTON	USA	Child Health and Human Development Extramural Research	001	5	4/11/2025	NON-COMPETING CONTINUATION	$60,301
														Subtotal = $1,009,482

Issue Date FY: 2024 ( Subtotal = $614,344 )
2024	2024	MICROGEN LLC	903 TEXAS AVE	LA MARQUE	TX	77568	GALVESTON	USA	Child Health and Human Development Extramural Research	001	4	5/2/2024	NON-COMPETING CONTINUATION	$55,850
2024	2024	MICROGEN LLC	903 TEXAS AVE	LA MARQUE	TX	77568	GALVESTON	USA	Child Health and Human Development Extramural Research	000	4	2/23/2024	NON-COMPETING CONTINUATION	$558,494
														Subtotal = $614,344

Issue Date FY: 2023 ( Subtotal = $627,249 )
2023	2023	MICROGEN LLC	903 TEXAS AVE	LA MARQUE	TX	77568	GALVESTON	USA	Child Health and Human Development Extramural Research	000	3	2/24/2023	NON-COMPETING CONTINUATION	$627,249
														Subtotal = $627,249

Issue Date FY: 2022 ( Subtotal = $625,951 )
2022	2022	MICROGEN, LLC	903 TEXAS AVE	LA MARQUE	TX	77568	GALVESTON	USA	Child Health and Human Development Extramural Research	000	2	2/25/2022	NON-COMPETING CONTINUATION	$563,356
2022	2022	MICROGEN LLC	903 TEXAS AVE	LA MARQUE	TX	77568	GALVESTON	USA	Child Health and Human Development Extramural Research	001	2	4/30/2022	NON-COMPETING CONTINUATION	$62,595
														Subtotal = $625,951

Issue Date FY: 2021 ( Subtotal = $643,393 )
2021	2021	MICROGEN, LLC	903 TEXAS AVE	LA MARQUE	TX	77568	GALVESTON	USA	Child Health and Human Development Extramural Research	001	1	5/28/2021	NEW	$2,767
2021	2021	MICROGEN, LLC	903 TEXAS AVE	LA MARQUE	TX	77568	GALVESTON	USA	Child Health and Human Development Extramural Research	000	1	4/7/2021	NEW	$640,626
														Subtotal = $643,393

Grand Total All Awards = $3,520,419

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Reductions in biopsychosocial risks for pregnant Latinas and their infants: the Mastery Lifestyle Intervention

Award Number: R01HD101535

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 07/14/2025

PERIOD OF PERFORMANCE END DATE: 02/28/2026

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