SUSTAIN: Behavior Change and Nutrition Security for CKMS

NCT06589336 | Completed

• 1 other identifier: 2023H0456
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

CKMS; Cardiometabolic Health; Cardiovascular-Kidney-Metabolic Health; Cardiovascular-Kidney-Metabolic Syndrome

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• Nutrition Security

  24 weeks

• Dietary Patterns

  24 weeks

• Cardiometabolic Health

  24 weeks

• Purchasing Behavior

  24 weeks

Study Arms (2)

Intervention Group

OTHER

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

Control Group

OTHER

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

Interventions

Dietary changes via Instacart vouchers OTHER

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.

Control Group; Intervention Group

Dietary changes via access to Mid-Ohio Farmacy OTHER

Mid-Ohio Farmacy will provide healthy food provisions through a network of food banks with fresh produce and other items.

Control Group; Intervention Group

Behavior changes via access to Health Impact Ohio Hub OTHER

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.

Intervention Group

Behavioral nutrition counseling OTHER

All dietary recommendations will be individualized and informed by existing guidelines to improve diet quality and cardiovascular health through the Mediterranean Diet.

Intervention Group

Cooking classes OTHER

Registered dietician nutritionists will also lead cooking demonstrations every 2 weeks, focused on culinary education and building engagement among SUSTAIN participants.

Intervention Group

Dietary changes to Delivery fees OTHER

Delivery fees will be supported for SUSTAIN participants.

Control Group; Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead
• American Heart Association: collaborator

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• Walker DM, Spees C, Brock G, Williams A, Smith J, Shrodes J, Gilmore D, Headings A, Baker C, Price T, Roberts MW, Frey E, Tatro J, McGlade L, Derry H, Johnson K, Joseph JJ. Promoting sustained behavior change and nutrition security in medicaid-enrolled individuals with stage 2 cardiovascular kidney metabolic syndrome (CKMS): Protocol of the SUSTAIN study. Contemp Clin Trials. 2026 Mar 10:108285. doi: 10.1016/j.cct.2026.108285. Online ahead of print.

  PMID: 41819445 DERIVED

Study Officials

• Joshua Joseph, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: September 19, 2024
• Study Start: August 26, 2024
• Primary Completion: August 29, 2025
• Study Completion: August 29, 2025
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)