Stage 2 Cardiovascular-Kidney-Metabolic SyndromeSUSTAINNCT06589336
SUSTAIN: Behavior Change and Nutrition Security for CKMS
A study testing Dietary changes via Instacart vouchers, Dietary changes via access to Mid-Ohio Farmacy and Behavior changes via access to Health Impact Ohio Hub in people with Stage 2 Cardiovascular-Kidney-Metabolic Syndrome and Cardiovascular Disease Other, run by Ohio State University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage 2 Cardiovascular-Kidney-Metabolic Syndrome, Cardiovascular Disease Other
- What is being tested?
- Dietary changes via Instacart vouchers, Dietary changes via access to Mid-Ohio Farmacy and Behavior changes via access to Health Impact Ohio Hub
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2024to 29 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
Official title: 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.
- Being tested
- Dietary changes via Instacart vouchers, Dietary changes via access to Mid-Ohio Farmacy, Behavior changes via access to Health Impact Ohio Hub, Behavioral nutrition counseling, Cooking classes
- Keywords
- CKMS, Cardiometabolic Health, Cardiovascular-Kidney-Metabolic Health, Cardiovascular-Kidney-Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary changes via Instacart vouchersOther
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.
Dietary changes via access to Mid-Ohio FarmacyOther
Mid-Ohio Farmacy will provide healthy food provisions through a network of food banks with fresh produce and other items.
Behavior changes via access to Health Impact Ohio HubOther
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.
Behavioral nutrition counselingOther
All dietary recommendations will be individualized and informed by existing guidelines to improve diet quality and cardiovascular health through the Mediterranean Diet.
Cooking classesOther
Registered dietician nutritionists will also lead cooking demonstrations every 2 weeks, focused on culinary education and building engagement among SUSTAIN participants.
Dietary changes to Delivery feesOther
Delivery fees will be supported for SUSTAIN participants.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Dietary changes via Instacart vouchers; Other: Dietary changes via access to Mid-Ohio Farmacy; Other: Dietary changes to Delivery fees |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment
Enrollment will be determined by the percent of eligible participants who enroll in the study.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 16 weeks
Retention
The percent of participants that complete the study visits at 12 and 24 weeks.
Measured: 24 weeks
Engagement
Engagement will be determined by the amount of total dollars spent on Instacart per participant.
Measured: 8 weeks
Secondary outcomes (4)
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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start26 Aug 2024
- Primary completion29 Aug 2025
- Study completion29 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stage 2 Cardiovascular-Kidney-Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Joshua Joseph, MD, Ohio State University
- Investigators
- Joshua Joseph, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589336
- Sponsor's protocol ID
- 2023H0456
- Acronym
- SUSTAIN
- Status last verified
- Dec 2025
- First submitted
- 25 Mar 2024
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 May;164:108285. doi: 10.1016/j.cct.2026.108285. Epub 2026 Mar 10.
PubMed 41819445
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SUSTAIN: Promoting Sustained Behavior Change and Nutrition Security in Medicaid-Enrolled Individuals With Stage 2 Cardiovascular-Kidney-Metabolic Syndrome (CKMS)
- ClinicalTrials.gov ID
- NCT06589336
- Acronym / sponsor ID
- SUSTAIN / 2023H0456
- Keywords
- CKMS, Cardiometabolic Health, Cardiovascular-Kidney-Metabolic Health, Cardiovascular-Kidney-Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 26 Aug 2024 (actual)
- Primary completion
- 29 Aug 2025 (actual)
- Study completion
- 29 Aug 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Other | 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 feesWeeks 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. |
| Control Group | Other | Other: Dietary changes via Instacart vouchers, Other: Dietary changes via access to Mid-Ohio Farmacy, Other: Dietary changes to Delivery feesWeeks 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary changes via Instacart vouchersInstacart 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 | Control Group, Intervention Group |
| Dietary changes via access to Mid-Ohio FarmacyMid-Ohio Farmacy will provide healthy food provisions through a network of food banks with fresh produce and other items. | Other | Control Group, Intervention Group |
| Behavior changes via access to Health Impact Ohio HubHealth 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 | Intervention Group |
| Behavioral nutrition counselingAll dietary recommendations will be individualized and informed by existing guidelines to improve diet quality and cardiovascular health through the Mediterranean Diet. | Other | Intervention Group |
| Cooking classesRegistered dietician nutritionists will also lead cooking demonstrations every 2 weeks, focused on culinary education and building engagement among SUSTAIN participants. | Other | Intervention Group |
| Dietary changes to Delivery feesDelivery fees will be supported for SUSTAIN participants. | Other | Control Group, Intervention Group |
Primary outcome
Enrollment
Time frame: Week 1
Enrollment will be determined by the percent of eligible participants who enroll in the study.
Adherence - Mid-Ohio Farmacy
Time frame: 24 weeks
Adherence will be determined based on the number of visits to food pantries divided by the total number of possible visits.
Adherence - Health Impact Ohio
Time frame: 24 weeks
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.
Adherence - Behavioral Nutritional Counseling
Time frame: 16 weeks
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.
Retention
Time frame: 24 weeks
The percent of participants that complete the study visits at 12 and 24 weeks.
Engagement
Time frame: 8 weeks
Engagement will be determined by the amount of total dollars spent on Instacart per participant.
4 secondary outcomes
Nutrition Security
Time frame: 24 weeks
Dietary Patterns
Time frame: 24 weeks
Cardiometabolic Health
Time frame: 24 weeks
Purchasing Behavior
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Derived from this study: PubMed 41819445Walker 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 May;164:108285. doi: 10.1016/j.cct.2026.108285. Epub 2026 Mar 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua Joseph, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary changes via Instacart vouchers, Dietary changes via access to Mid-Ohio Farmacy and Behavior changes via access to Health Impact Ohio Hub in people with Stage 2 Cardiovascular-Kidney-Metabolic Syndrome and Cardiovascular Disease Other, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment (time frame: Week 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06589336, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.