NCT06589336

SUSTAIN: Behavior Change and Nutrition Security for CKMS

SUSTAIN: Promoting Sustained Behavior Change and Nutrition Security in Medicaid-Enrolled Individuals With Stage 2 Cardiovascular-Kidney-Metabolic Syndrome (CKMS)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To 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). Methods: Leveraging rigorous quantitative and qualitative evaluation, the study team will identify mechanisms driving intervention feasibility and engagement. Hypothesis: SUSTAIN will be feasible with a high degree of engagement among Medicaid-enrolled participants with Stage 2 CKMS in comparison to enhanced usual care.

Conditions

• Stage 2 Cardiovascular-Kidney-Metabolic Syndrome
• Cardiovascular Disease Other

Interventions

Type	Name	Description
OTHER	Dietary changes via Instacart vouchers	Instacart will provide consumers with the dignity of choice to shop at preferred retail stores, which is key for our behavioral change strategy. Delivery and service fees will be waived for patients, so 100% of the vouchers will be applied to groceries (all food products excluding alcohol and tobacco). The investigators will use a custom study store front with an integrated website and email option.
OTHER	Dietary changes via access to Mid-Ohio Farmacy	Mid-Ohio Farmacy will provide healthy food provisions through a network of food banks with fresh produce and other items.
OTHER	Behavior changes via access to Health Impact Ohio Hub	Health Impact Ohio Hub is a regional coordination entity that has connections with community care agencies that employ community health workers to assess social needs and make connections to resources to address social needs. The community health workers will conduct an initial needs assessment, and guide the participant through appropriate care pathways to address social needs.
OTHER	Behavioral nutrition counseling	All dietary recommendations will be individualized and informed by existing guidelines to improve diet quality and cardiovascular health through the Mediterranean Diet.
OTHER	Cooking classes	Registered dietician nutritionists will also lead cooking demonstrations every 2 weeks, focused on culinary education and building engagement among SUSTAIN participants.
OTHER	Dietary changes to Delivery fees	Delivery fees will be supported for SUSTAIN participants.

Timeline

• Start date: 2024-08-26
• Primary completion: 2025-08-29
• Completion: 2025-08-29
• First posted: 2024-09-19
• Last updated: 2025-12-11

Locations

1 site across 1 country: United States