Contemporary Clinical Trials · Mar 10, 2026

Promoting sustained behavior change and nutrition security in medicaid-enrolled individuals with stage 2 cardiovascular kidney metabolic syndrome (CKMS): Protocol of the SUSTAIN study

By Walker DM, Spees C, Brock G et al.

BACKGROUND: Medicaid-enrolled populations are disproportionately impacted by suboptimal dietary intake leading to a high prevalence of Stage 2 cardiovascular-kidney-metabolic syndrome (CKMS), and lower Life's Essential 8 (LE8) cardiovascular health (CVH) measures. METHODS: A pilot randomized controlled trial to test the feasibility, engagement, and preliminary efficacy of a novel Food-is-Medicine (FIM) intervention in Medicaid-enrolled adults with Stage 2 CKMS. SETTING: Participants were recruited from an academic medical center in an urban environment in the Midwest. DESIGN: Parallel group design. INTERVENTIONS: SUSTAIN tests a phased-approach over 24 weeks: Weeks 1-8: Instacart food vouchers (known as Fresh Funds) and home delivery, behavioral nutrition counseling and culinary education, community health worker (CHW)-led social needs coordination, and produce prescription via Mid-Ohio Farmacy (MOF) access; Weeks 9-16: study supported Instacart platform access without the vouchers (Fresh Funds), while other components remain the same; Weeks 17-24: option to continue Instacart without study support, counseling and culinary education cease, and MOF and CHW continue. Control participants receive the same intervention without counseling and culinary education or the CHW. OUTCOMES: Primary and secondary outcomes include study enrollment, adherence to intervention components (i.e., total Instacart spending, counseling sessions, number of food pantry visits, linkage with CHW), retention across study visits, acceptability (i.e, satisfaction), practicality (i.e., participant costs), adaptations to the intervention, and efficacy (i.e., dietary patterns, nutrition security, American Heart Association's Life's Essential 8). DISCUSSION: Scalable FIM approaches to improve CVH in individuals with Stage 2 CKMS are needed to inform inclusive and impactful interventions to address nutrition security. CLINICALTRIALS: gov: NCT06589336.

doi.org/10.1016/j.cct.2026.108285 PubMed 41819445 Interventions