Status:
COMPLETED
SUSTAIN: Behavior Change and Nutrition Security for CKMS
Lead Sponsor:
Ohio State University
Collaborating Sponsors:
American Heart Association
Conditions:
Stage 2 Cardiovascular-Kidney-Metabolic Syndrome
Cardiovascular Disease Other
Eligibility:
All Genders
18+ years
Phase:
NA
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, adher...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 29 2025
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT06589336
Start Date
August 26 2024
End Date
August 29 2025
Last Update
December 11 2025
Active Locations (1)
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1
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210