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

Top Things to Know

Food access alone is unlikely to drive sustained health benefit without behavior change support.

Tapering financial incentives may support sustainability in FIM model.

Integrating social needs coordination strengthens the FIM impact pathway.

Summary of Conclusion/Findings

This paper presents the protocol for the SUSTAIN Study, a 24‑week pilot randomized controlled trial designed to evaluate the feasibility, engagement, and preliminary efficacy of a multicomponent Food Is Medicine intervention among Medicaid‑enrolled adults with Stage 2 cardiovascular‑kidney‑metabolic syndrome (CKMS). The study tests an intentionally phased and tapered intervention, combining short‑term grocery subsidies and home delivery, produce prescriptions, dietitian‑led behavioral nutrition counseling and culinary education, and community health worker–led social needs coordination. A major strength of the design is its use of a control group, validated dietary and nutrition security measures, objective biomarkers (e.g., dermal carotenoids), and mixed‑methods evaluation, addressing common limitations of prior FIM studies. Another notable feature is the gradual withdrawal of financial supports to examine whether early intensive assistance can lead to sustained behavior change once subsidies end. As a pilot, the study is not powered for definitive clinical outcomes, but rather to generate effect size estimates, assess implementation barriers, and refine intervention components. Overall, the protocol reflects a move from proof‑of‑concept toward implementation‑relevant evidence to inform scalable, Medicaid‑focused FIM models.