Accepted for/Published in: JMIR Research Protocols
Date Submitted: Mar 20, 2024
Date Accepted: Jun 18, 2024
Protective Assets Reinforced with Integrated care and TechnologY (PARITY): Protocol for a Randomized Control Feasibility Trial
ABSTRACT
Background:
Black women are significantly more likely to experience severe maternal morbidity and are three times as likely to die from pregnancy-related causes compared to white women. Utilizing a strengths-based wellness approach within an integrated supportive care program provided by a community doula could provide pragmatic solutions for Black maternal disparities. The Protective Assets Reinforced through Integrated care and TechnolgY (PARITY) program consists of a wellness technology platform, including informational links to wellness content and reinforcing motivational text messages, as well as community-based doula support delivered both in-person and through the technology platform to improve Black maternal wellness.
Objective:
The objectives of this pilot randomized control trial (RCT) and mixed methods evaluation are 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) to investigate changes to wellness behavioral outcomes (nutrition, physical activity, sleep, and healthcare adherence) and empowered strengths (self-efficacy, social support, motivation, resilience, problem-solving, and self-regulation) in the intervention group as compared to a control group.
Methods:
A two-arm randomized control trial and mixed methods evaluation will be used. A total of 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 four 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), 36th week of pregnancy, birth, and 6-12 weeks postpartum.
Results:
This pilot RCT was funded by the National Institute of Nursing Research (NINR). 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 feasibility and preliminary efficacy of the PARITY intervention which will be used for a larger trial using a 12-month PARITY program intervention. Clinical Trial: NCT05802615
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