SUSTAIN: Behavior Change and Nutrition Security for CKMS (SUSTAIN)

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease Other; Stage 2 Cardiovascular-Kidney-Metabolic Syndrome
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intervention Group; Weeks 1-8: The intervention group will receive Instacart groceries (voucher + delivery fees), access to the Mid-Ohio Farmacy Program, behavioral nutrition counseling, and social needs screening and referrals. Weeks 9-16: The intervention group will receive Instacart groceries (delivery fees only), access to Mid-Ohio Farmacy program, behavioral nutrition counseling and social needs screening and referrals. Weeks 17-24: The intervention group will receive Instacart access (no financial support), access to the Mid-Ohio Farmacy Program and social needs screening and referrals.	Other: Dietary changes via Instacart vouchers; Instacart will provide consumers with the dignity of choice to shop at preferred retail stores, which is key for our behavioral change strategy. Delivery and service fees will be waived for patients, so 100% of the vouchers will be applied to groceries (all food products excluding alcohol and tobacco). The investigators will use a custom study store front with an integrated website and email option.; Other: Dietary changes via access to Mid-Ohio Farmacy; Mid-Ohio Farmacy will provide healthy food provisions through a network of food banks with fresh produce and other items.; Other: Behavior changes via access to Health Impact Ohio Hub; Health Impact Ohio Hub is a regional coordination entity that has connections with community care agencies that employ community health workers to assess social needs and make connections to resources to address social needs. The community health workers will conduct an initial needs assessment, and guide the participant through appropriate care pathways to address social needs.; Other: Behavioral nutrition counseling; All dietary recommendations will be individualized and informed by existing guidelines to improve diet quality and cardiovascular health through the Mediterranean Diet.; Other: Cooking classes; Registered dietician nutritionists will also lead cooking demonstrations every 2 weeks, focused on culinary education and building engagement among SUSTAIN participants.; Other: Dietary changes to Delivery fees; Delivery fees will be supported for SUSTAIN participants.
Other: Control Group; Weeks 1-8: The control group will receive Instacart groceries (voucher + delivery fees) and access to the Mid-Ohio Farmacy program. Weeks 9-16: The control group will receive Instacart groceries (delivery fees only) and access to the Mid-Ohio Farmacy program. Weeks 17-24: The control group will receive Instacart access (no financial support) and access to the Mid-Ohio Farmacy program.	Other: Dietary changes via Instacart vouchers; Instacart will provide consumers with the dignity of choice to shop at preferred retail stores, which is key for our behavioral change strategy. Delivery and service fees will be waived for patients, so 100% of the vouchers will be applied to groceries (all food products excluding alcohol and tobacco). The investigators will use a custom study store front with an integrated website and email option.; Other: Dietary changes via access to Mid-Ohio Farmacy; Mid-Ohio Farmacy will provide healthy food provisions through a network of food banks with fresh produce and other items.; Other: Dietary changes to Delivery fees; Delivery fees will be supported for SUSTAIN participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment	Enrollment will be determined by the percent of eligible participants who enroll in the study.	Week 1
Adherence - Mid-Ohio Farmacy	Adherence will be determined based on the number of visits to food pantries divided by the total number of possible visits.	24 weeks
Adherence - Health Impact Ohio	Adherence to the Health Impact Ohio component of the intervention to address social needs will be determined based on the percent of participants that enroll with the community health worker.	24 weeks
Adherence - Behavioral Nutritional Counseling	Adherence to behavioral nutritional counseling will be determined by the number of interactions with behavioral counseling out of the total number of counseling sessions offered.	16 weeks
Retention	The percent of participants that complete the study visits at 12 and 24 weeks.	24 weeks
Engagement	Engagement will be determined by the amount of total dollars spent on Instacart per participant.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutrition Security	Nutrition security will be measured using the Center for Nutrition and Health Impact Nutrition Security Screener. The screener has 4 questions with score ranging from Never = 4, Rarely = 3 Sometimes = 2, Often = 1, Always = 0. The 4 question scores are averaged for a final score. Higher scores indicate a greater degree of Household Nutrition Security.	24 weeks
Dietary Patterns	Mediterranean Eating Pattern for Americans (MEPA) Version III will be used to assess changes in the MEPA. The MEPA screener includes 21 questions on the consumption of foods typical of the Mediterranean diet as well as fast food, convenience foods, and sugar-sweetened beverages. The total MEPA-III score ranges from 0 to 21 (higher scores indicate greater intakes of Mediterranean foods). Change in MEPA Scores at 24-week follow-up will be calculated using between-subject differences, using a linear mixed-effects to evaluate changes from baseline in MEPA score (range 0-21, higher scores are better).	24 weeks
Cardiometabolic Health	American Heart Association Life Essential 8 will be calculated with a range of 0-100 to measure cardiometabolic health. Change in cardiometabolic health at 24-week follow-up will be calculated using between-subject differences, using a linear mixed-effects to evaluate changes from baseline in Life's Essential 8 score (range 0-100, higher scores are better).	24 weeks
Purchasing Behavior	Purchasing behavior will be analyzed by measuring the types of food purchased using receipts from instacart. The instacart receipts will be coded into categories of food consistent with a Mediterranean healthy eating pattern (i.e. fruits, vegetables, nuts, etc.) and changes will be evaluated over the 24 weeks.	24 weeks

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: American Heart Association
• Investigators: Principal Investigator: Joshua Joseph, MD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2024
• Primary Completion (Actual): August 29, 2025
• Study Completion (Actual): August 29, 2025

Study Registration Dates

• First Submitted: March 25, 2024
• First Submitted That Met QC Criteria: September 5, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): December 11, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Cardiometabolic Health; Cardiovascular-Kidney-Metabolic Syndrome; CKMS; Cardiovascular-Kidney-Metabolic Health
• Other Study ID Numbers: 2023H0456

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No