Abstract P1037: Promoting Sustained Behavior Change and Nutrition Security in Medicaid-Enrolled Individuals with Stage 2 Cardiovascular Kidney Metabolic Syndrome (CKMS): protocol and early recruitment success of the SUSTAIN study

Abstract

Introduction: Medicaid-enrolled populations are disproportionately impacted by suboptimal nutrition leading to lower Life’s Essential 8 (LE8) cardiovascular health (CVH) scores and greater prevalence of Stage 2 cardiovascular-kidney-metabolic syndrome (CKMS) as defined by the American Heart Association (AHA). With support from the AHA Health Care by Food TM Initiative and leveraging existing academic-community-government-industry partnerships, our team is assessing the feasibility, engagement, and preliminary efficacy of SUSTAIN , a novel Food is Medicine (FIM) intervention in Medicaid-enrolled individuals with Stage 2 CKMS. Hypothesis: Our overall hypothesis is that a comprehensive FIM intervention including culturally appropriate and home-delivered groceries, intensive and tailored behavioral nutrition counseling, and social care coordination will improve nutrition security and CVH compared to individuals receiving home-delivered groceries only. Methods: Informed by the socioecological model and human-centered design, SUSTAIN is a 24-week randomized controlled trial (RCT) of Medicaid-enrolled individuals (n=100) with Stage 2 CKMS to: Aim 1 : Determine the feasibility and engagement of participants in the SUSTAIN intervention compared to enhanced usual care over 24 weeks through mixed-methods measurement of participant enrollment, adherence, retention, and engagement (counseling, screenings, referrals, and uptake); Aim 2 : Determine the preliminary efficacy of the SUSTAIN intervention compared to enhanced usual care in improving behavior change as measured by nutrition security, LE8 measures, biometrics, and purchasing behaviors over 24 weeks to determine effect estimates to robustly power a future RCT. Results: Initial recruitment efforts have enrolled 46 individuals; 148 failed to meet eligibility criteria. Primary reasons for ineligibility were other diagnoses (e.g., heart failure) (n=107) and non-English speaking (n=31). A minority of participants were ineligible due to unwillingness to use mobile phone-based technology (n=2) or lack of backup form of payment for grocery vendor (n=3). Conclusions: Innovative FIM solutions are urgently needed. SUSTAIN will explicate the feasibility, engagement, and preliminary efficacy of SUSTAIN, leading to a scalable FIM nutrition-security-based model to improve CVH in Stage 2 CKMS. SUSTAIN has the potential to drive a paradigm shift in healthcare, fostering healthier, nutrition-secure and resilient communities.