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OpenTrials
Completed

NCT Number: NCT06589336

SUSTAIN: Behavior Change and Nutrition Security for 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.

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Key information

Conditions

Stage 2 Cardiovascular-Kidney-Metabolic Syndrome Cardiovascular Disease Other

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

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.

Cooking classes

Other

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 fees

Other

Delivery fees will be supported for SUSTAIN participants.

Primary outcomes

  1. Enrollment

    Time frame: Week 1

    Enrollment will be determined by the percent of eligible participants who enroll in the study.

  2. 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.

  3. 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.

  4. 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.

  5. Retention

    Time frame: 24 weeks

    The percent of participants that complete the study visits at 12 and 24 weeks.

  6. Engagement

    Time frame: 8 weeks

    Engagement will be determined by the amount of total dollars spent on Instacart per participant.

Secondary outcomes

  1. Nutrition Security

    Time frame: 24 weeks

    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.

  2. Dietary Patterns

    Time frame: 24 weeks

    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).

  3. Cardiometabolic Health

    Time frame: 24 weeks

    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).

  4. Purchasing Behavior

    Time frame: 24 weeks

    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.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • American Heart Association

Registry information

Official study title

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

Acronym: SUSTAIN

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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