Clinical trial NCT06589336: SUSTAIN: Behavior Change and Nutrition Security for CKMS
Official title: SUSTAIN: Promoting Sustained Behavior Change and Nutrition Security in Medicaid-Enrolled Individuals With Stage 2 Cardiovascular-Kidney-Metabolic Syndrome (CKMS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stage 2 Cardiovascular-Kidney-Metabolic Syndrome
Cardiovascular Disease Other
Keywords: CKMS
Cardiometabolic Health
Cardiovascular-Kidney-Metabolic Health
Cardiovascular-Kidney-Metabolic Syndrome
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2024-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Enrollment
timeFrame: Week 1
measure: Adherence - Mid-Ohio Farmacy
timeFrame: 24 weeks
measure: Adherence - Health Impact Ohio
timeFrame: 24 weeks
measure: Adherence - Behavioral Nutritional Counseling
timeFrame: 16 weeks
measure: Retention
timeFrame: 24 weeks
measure: Engagement
timeFrame: 8 weeks
Secondary outcomes:
measure: Nutrition Security
timeFrame: 24 weeks
measure: Dietary Patterns
timeFrame: 24 weeks
measure: Cardiometabolic Health
timeFrame: 24 weeks
measure: Purchasing Behavior
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Joshua Joseph, MD
role: PRINCIPAL_INVESTIGATOR
References: