Behavior change and nutrition support for patients with cardiovascular-kidney-metabolic syndrome
SUSTAIN: Promoting Sustained Behavior Change and Nutrition Security in Medicaid-Enrolled Individuals With Stage 2 Cardiovascular-Kidney-Metabolic Syndrome (CKMS)
This study is testing whether a program that offers grocery vouchers and nutrition counseling can help people with Stage 2 Cardiovascular-Kidney-Metabolic Syndrome improve their health and stick with the changes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ohio State University Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT06589336 on ClinicalTrials.gov |
What this trial studies
This intervention focuses on improving the health of Medicaid-enrolled participants with Stage 2 Cardiovascular-Kidney-Metabolic Syndrome (CKMS) through a combination of dietary changes and behavioral counseling. Participants will receive support such as Instacart vouchers for grocery shopping, access to local farmacy resources, and nutrition counseling. The study aims to assess the feasibility and engagement of participants over a 24-week period by measuring enrollment, adherence, retention, and overall engagement with the intervention. The hypothesis is that the SUSTAIN intervention will demonstrate high feasibility and engagement compared to enhanced usual care.
Who should consider this trial
Good fit: Ideal candidates for this study are Medicaid-enrolled adults aged 18 and older diagnosed with hypertension, type 2 diabetes, hyperlipidemia, chronic kidney disease, or metabolic syndrome.
Not a fit: Patients with conditions that severely impact digestion, metabolism, or food intake, such as certain digestive illnesses or surgical alterations, may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the health outcomes of patients with CKMS by promoting better dietary habits and lifestyle changes.
How similar studies have performed: Other studies have shown promise in using dietary interventions and behavioral counseling to improve health outcomes in similar populations, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Columbus, Ohio
- The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Joshua Joseph, MD — Ohio State University
- Study coordinator: Erin Frey
- Email: Erin.Frey@osumc.edu
- Phone: 614-293-8973
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.