SUSTAIN: Behavior Change and Nutrition Security for CKMS

NCT ID: NCT06589336

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-26
• Study Completion Date: 2025-08-29

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Group

Weeks 1-8: The intervention group will receive Instacart groceries (voucher + delivery fees), access to the Mid-Ohio Farmacy Program, behavioral nutrition counseling, and social needs screening and referrals.

Weeks 9-16: The intervention group will receive Instacart groceries (delivery fees only), access to Mid-Ohio Farmacy program, behavioral nutrition counseling and social needs screening and referrals.

Weeks 17-24: The intervention group will receive Instacart access (no financial support), access to the Mid-Ohio Farmacy Program and social needs screening and referrals.

Group Type: OTHER

Cooking classes

Intervention Type: OTHER

Registered dietician nutritionists will also lead cooking demonstrations every 2 weeks, focused on culinary education and building engagement among SUSTAIN participants.

Dietary changes to Delivery fees

Intervention Type: OTHER

Delivery fees will be supported for SUSTAIN participants.

Dietary changes via Instacart vouchers

Intervention Type: OTHER

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.

Dietary changes via access to Mid-Ohio Farmacy

Intervention Type: OTHER

Mid-Ohio Farmacy will provide healthy food provisions through a network of food banks with fresh produce and other items.

Behavior changes via access to Health Impact Ohio Hub

Intervention Type: OTHER

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.

Behavioral nutrition counseling

Intervention Type: OTHER

All dietary recommendations will be individualized and informed by existing guidelines to improve diet quality and cardiovascular health through the Mediterranean Diet.

Control Group

Weeks 1-8: The control group will receive Instacart groceries (voucher + delivery fees) and access to the Mid-Ohio Farmacy program.

Weeks 9-16: The control group will receive Instacart groceries (delivery fees only) and access to the Mid-Ohio Farmacy program.

Weeks 17-24: The control group will receive Instacart access (no financial support) and access to the Mid-Ohio Farmacy program.

Group Type: OTHER

Dietary changes to Delivery fees

Intervention Type: OTHER

Delivery fees will be supported for SUSTAIN participants.

Dietary changes via Instacart vouchers

Intervention Type: OTHER

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.

Dietary changes via access to Mid-Ohio Farmacy

Intervention Type: OTHER

Mid-Ohio Farmacy will provide healthy food provisions through a network of food banks with fresh produce and other items.

Interventions

Cooking classes

Registered dietician nutritionists will also lead cooking demonstrations every 2 weeks, focused on culinary education and building engagement among SUSTAIN participants.

Intervention Type: OTHER

Dietary changes to Delivery fees

Delivery fees will be supported for SUSTAIN participants.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients must be Medicaid enrolled, and/or dual enrolled in Medicaid
• Patients must be diagnosed with at least one of the following diseases: hypertension, type 2 diabetes mellitus, hyperlipidemia, chronic kidney disease and/or metabolic syndrome
• Patients must at least 18 years of age or older at the time of signing consent
• Patient must have access to internet-enabled device
• Patient has no objections to online grocery shopping, home food deliveries, or nutrition counseling
• Patient lives in setting able to receive Instacart deliveries (e.g., non-institutionalized)
• Patient is willing to use a credit card for Instacart back-up payments

Exclusion Criteria

• Have any condition that impacts digestion, metabolism, or food intake (e.g., surgical loss of esophagus, stomach, or colon, pancreatic dysfunction, bariatric surgery, brain surgery that alters cognition, etc.)
• Have active digestive illnesses (i.e., Celiac disease, irritable bowel syndrome, chronic malabsorption)
• Any comorbidity such as psychiatric or general illness that may put the subject at risk as determined by investigator
• Any other factor which, in the investigator's opinion, is likely to compromise the subject's ability to participate in the study
• Recent (e.g., 6 months) participation in other behavioral nutrition trials
• Are currently pregnant or are planning to become pregnant during the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Heart Association

OTHER

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Joshua Joseph, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joshua Joseph, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Countries

United States

Other Identifiers

2023H0456

Identifier Type: -

Identifier Source: org_study_id