SUSTAIN: Behavior Change and Nutrition Security for CKMS

The Ohio State University

Status: Completed

Conditions: Cardiovascular Disease Other; Stage 2 Cardiovascular-Kidney-Metabolic Syndrome

Treatments: Other: Behavior changes via access to Health Impact Ohio Hub; Other: Dietary changes via Instacart vouchers; Other: Behavioral nutrition counseling; Other: Dietary changes via access to Mid-Ohio Farmacy; Other: Dietary changes to Delivery fees; Other: Cooking classes

Study type: Interventional

Funder types: Other

Identifiers

NCT06589336

2023H0456

Details and patient eligibility

About

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.

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

Intervention Group

Other group

Description:

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.

Treatment:

Other: Cooking classes

Other: Dietary changes to Delivery fees

Other: Dietary changes via access to Mid-Ohio Farmacy

Other: Behavioral nutrition counseling

Other: Dietary changes via Instacart vouchers

Other: Behavior changes via access to Health Impact Ohio Hub

Control Group

Other group

Description:

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.

Treatment:

Other: Dietary changes to Delivery fees

Other: Dietary changes via access to Mid-Ohio Farmacy

Other: Dietary changes via Instacart vouchers