RESUMEN
BACKGROUND: Black women are significantly more likely to experience severe maternal morbidity and are 3 times as likely to die from pregnancy-related causes compared to White women. Using a strengths-based wellness approach within an integrated supportive care program provided by a community doula could offer pragmatic solutions for Black maternal disparities. The Protective Assets Reinforced with Integrated Care and Technology (PARITY) program consists of a wellness technology platform, including informational links to wellness content and reinforcing motivational SMS text messages, as well as community-based doula support delivered both in person and through the technology platform to improve Black maternal wellness. OBJECTIVE: This pilot randomized controlled trial (RCT) and mixed methods evaluation aims to (1) determine the feasibility and acceptability of the PARITY intervention; (2) investigate the preliminary efficacy of the PARITY intervention on clinical outcomes (maternal blood pressure, gestational weight gain, and cesarean birth); and (3) investigate changes to wellness behavioral outcomes (nutrition, physical activity, sleep, and health care adherence) and empowered strengths (self-efficacy, social support, motivation, resilience, problem-solving, and self-regulation) in the intervention group compared to a control group. METHODS: A 2-arm RCT and mixed methods evaluation will be conducted. Overall, 60 Black pregnant individuals will be randomized in a ratio of 1:1 to either the intervention or informational control group. Participants in the intervention group will receive access to the technology platform over a 12-week period that ends before birth. Intervention participants will be assigned a doula interventionist, who will meet with them 4 times during the intervention. All participants (intervention and control) will receive a referral for a birth doula at no cost, printed materials about having a healthy pregnancy, and community resources. Feasibility and acceptability will be assessed at the end of the program. Measures will be obtained at baseline (20-28 weeks), the 36th week of pregnancy, birth, and 6-12 weeks post partum. Summary statistics and distribution plots will be used to describe measured variables at each time point. A generalized linear mixed model with a shared random component will be used to analyze the effects of PARITY on clinical, wellness behavioral, and empowered strength outcomes, including baseline nutrition, physical activity, and sleep measures as covariates. For significant effects, post hoc contrasts will be adjusted using the Holm method to maintain comparison-wise error at or <.05. Missing data will be addressed using a pattern-mixture model. RESULTS: The National Institute of Nursing Research funded this pilot RCT. Recruitment, enrollment, and data collection are ongoing, and the estimated study completion date is October 2024. CONCLUSIONS: The expected results of this study will provide the feasibility and preliminary efficacy of the PARITY intervention, to be used in a larger trial with a 12-month PARITY program intervention. TRIAL REGISTRATION: ClinicalTrials.gov NCT05802615; https://clinicaltrials.gov/study/NCT05802615. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/58580.
Asunto(s)
Promoción de la Salud , Humanos , Femenino , Embarazo , Adulto , Proyectos Piloto , Promoción de la Salud/métodos , Negro o Afroamericano , Prestación Integrada de Atención de SaludRESUMEN
OBJECTIVES: Research on Black maternal populations often focuses on deficits that can reinforce biases against Black individuals and communities. The research landscape must shift towards a strengths-based approach focused on the protective assets of Black individuals and communities to counteract bias. This study engaged the local Black community using a strengths-based approach to discuss the assets of Black maternal populations and to inform the design of a future clinical trial focused on reducing Black maternal health disparities. DESIGN: Guided by the Theory of Maternal Adaptive Capacity, we conducted three purposive focus group sessions with Black adult community members. The focus groups were semi-structured to cover specific topics, including the strengths of theâ¯localâ¯community,â¯strengths specific to pregnant community members,â¯how the strengths of community members can support pregnant individuals,â¯and how the strengths of pregnant community members can facilitate a healthy pregnancy. The focus group interviews were transcribed verbatim and analyzed using thematic content analysis. RESULTS: Three focus group sessions were conducted with sixteen female individuals identifying as Black or African American. Central themes include (1) the power of pregnancy and motherhood in Black women, (2) challenging negative perceptions and media representation of Black mothers, (3) recognizing history and reclaiming cultural traditions surrounding birth, and (4) community as the foundation of Black motherhood. CONCLUSION: Black community members identified powerful themes on Black maternal health through a strengths-based lens. These focus groups fostered relationships with the Black community, elucidated possible solutions to improve Black women's health and wellness, and offered direction on our research design and intervention.