SUSTAIN: Behavior Change and Nutrition Security for 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.

Conditions

Stage 2 Cardiovascular-Kidney-Metabolic Syndrome, Cardiovascular Disease Other

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Study Overview

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Study Details

Study overview

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.

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

SUSTAIN: Behavior Change and Nutrition Security for CKMS

Condition
Stage 2 Cardiovascular-Kidney-Metabolic Syndrome
Intervention / Treatment

-

Contacts and Locations

Columbus

The Ohio State University Wexner Medical Center, Columbus, Ohio, United States, 43210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ohio State University,

Joshua Joseph, MD, PRINCIPAL_INVESTIGATOR, The Ohio State University Wexner Medical Center

Study Record Dates

2025-12-01