AI-enhanced personalized dietitian coaching and produce prescription to improve cardiovascular-kidney-metabolic (CKM) health: iTHRIVE - Modified Project Summary/Abstract Section Cardiovascular-kidney-metabolic (CKM) syndrome affects adults with limited access to care, healthy food, and personalized nutrition support. Innovative approaches to sustainably improve food access and CKM health among underserved populations eligible for Medicaid are urgently needed. The iTHRIVE program introduces a novel AI-enhanced personalized dietary intervention approach, combining AI-powered virtual dietitian assistant, personalized produce prescriptions, registered dietitian coaching, and digital platform engagement. Using a Hybrid Type 1 effectiveness-implementation design, this study will test whether iTHRIVE improves systolic blood pressure (primary outcome) at 6 months, compared to enhanced usual care among 200 adults eligible for Medicaid with Stage 2 CKM syndrome (hypertriglyceridemia OR hypertension OR type 2 diabetes) AND uncontrolled blood pressure at two primary care practices: Johns Hopkins Community Physicians in Baltimore, Maryland and Beth Israel Deaconess Medical Center outpatient clinic in Boston, Massachusetts. Participants, recruited from primary care practices, will be randomized to: (1) iTHRIVE (AI-enhanced personalized nutrition recommendations, virtual dietitian assistant, produce prescriptions, registered dietitian coaching, and digital platform engagement), or (2) enhanced usual care (general dietary advice and standard nutrition education). The study aims to: 1) Assess the efficacy of iTHRIVE in reducing systolic BP at 6 months (Primary Aim, Clinical Effectiveness); 2) Evaluate the impact of iTHRIVE on dietary quality at 6 months (Secondary Aim, Behavioral Effectiveness); and 3) Identify mechanisms through which AI-enhanced iTHRIVE improves dietary behaviors and implementation outcomes using CFIR and PRISM frameworks (Implementation Aim). This study addresses critical gaps in implementing effective AI-enhanced lifestyle interventions among adults with CKM syndrome in primary care settings. Informed by co-design sessions with 36 adults with CKM syndrome, iTHRIVE, an AI-enhanced approach that integrates personalized nutrition support with primary care delivery, aims to create a scalable model for improving CKM health outcomes. If successful, our rigorous evaluation strategy will inform scale-up and primary care-community integration of this AI-enhanced Food-as-Medicine intervention for CKM management. Our dissemination and sustainability strategy will involve sharing findings with key partners, including clinicians, health systems, and community organizations, to inform adoption and practice changes that improve dietary quality and CKM health outcomes.
