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


Description

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.

Trial Eligibility

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

Study Info

Organization

Ohio State University


Primary Outcome

Enrollment


Outcome Timeframe Week 1

NCTID NCT06589336

Phases NA

Primary Purpose TREATMENT

Start Date 2024-08-26

Completion Date 2025-12-01

Enrollment Target 100

Interventions

OTHER Dietary changes via Instacart vouchers

OTHER Dietary changes via access to Mid-Ohio Farmacy

OTHER Behavior changes via access to Health Impact Ohio Hub

OTHER Behavioral nutrition counseling

OTHER Cooking classes

OTHER Dietary changes to Delivery fees

Locations Recruiting

The Ohio State University Wexner Medical Center

United States, Ohio, Columbus


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