An interventional study of Dietary changes via Instacart vouchers and Dietary changes via access to Mid-Ohio Farmacy in Stage 2 Cardiovascular-Kidney-Metabolic Syndrome and Cardiovascular Disease Other, sponsored by Ohio State University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-11.
Sponsored by Ohio State University · Not applicable, Interventional, and Treatment
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.
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Exclusion Criteria:
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 · 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
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 · Other: Dietary changes via access to Mid-Ohio Farmacy · Other: Dietary changes to Delivery fees
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.
Mid-Ohio Farmacy will provide healthy food provisions through a network of food banks with fresh produce and other items.
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.
All dietary recommendations will be individualized and informed by existing guidelines to improve diet quality and cardiovascular health through the Mediterranean Diet.
Registered dietician nutritionists will also lead cooking demonstrations every 2 weeks, focused on culinary education and building engagement among SUSTAIN participants.
Delivery fees will be supported for SUSTAIN participants.
Enrollment
Enrollment will be determined by the percent of eligible participants who enroll in the study.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 16 weeks
Retention
The percent of participants that complete the study visits at 12 and 24 weeks.
Time frame: 24 weeks
Engagement
Engagement will be determined by the amount of total dollars spent on Instacart per participant.
Time frame: 8 weeks
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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 24 weeks
Plan to share: No
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