SUSTAIN: Behavior Change and Nutrition Security for CKMS

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

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.

Sponsors & Collaborators

• American Heart Association

  collaborator OTHER

• Ohio State University

  lead OTHER

Principal Investigators

• Joshua Joseph, MD · Ohio State University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-26

Primary Completion

2025-08-29

Completion

2025-08-29

Countries

• United States

Study Locations