SUSTAIN: Behavior Change and Nutrition Security for CKMS

Not Applicable

Recruiting

• Conditions: Stage 2 Cardiovascular-Kidney-Metabolic Syndrome; Cardiovascular Disease Other

• Registration Number: NCT06589336
• Lead Sponsor: Ohio State University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-25
• Study Start: 2024-08-26
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-05
• Last Update Submitted: 2024-09-09
• Study First Posted: 2024-09-10
• Last Update Posted: 2024-09-16
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Enrollment	Week 1	Enrollment will be determined by the percent of eligible participants who enroll in the study.
Adherence - Mid-Ohio Farmacy	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	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	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	24 weeks	The percent of participants that complete the study visits at 12 and 24 weeks.
Engagement	8 weeks	Engagement will be determined by the amount of total dollars spent on Instacart per participant.

Secondary Outcome Measures

Name	Time	Method
Nutrition Security	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.
Dietary Patterns	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).
Cardiometabolic Health	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).
Purchasing Behavior	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.

Trial Locations

Locations (1)

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States