← Back to Search

Behavioural Intervention

Dietary and Behavioral Changes for Metabolic Syndrome (SUSTAIN Trial)

N/A

Recruiting

Led By Joshua Joseph, MD

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must at least 18 years of age or older at the time of signing consent

Patients must be Medicaid enrolled, and/or dual enrolled in Medicaid

Must not have

Have active digestive illnesses (i.e., Celiac disease, irritable bowel syndrome, chronic malabsorption)

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.)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will assess whether the SUSTAIN intervention is effective and engaging for participants compared to typical care over 24 weeks. The study will look at how many people enroll, follow through with the intervention

Who is the study for?

The SUSTAIN trial is for individuals with Stage 2 Chronic Kidney Disease Metabolic Syndrome (CKMS), who are also enrolled in Medicaid. It's designed to help those at risk of cardiovascular disease by improving their nutrition and behavior related to health.

What is being tested?

This study tests a program called SUSTAIN, which includes dietary changes through Mid-Ohio Farmacy access, Instacart vouchers, behavioral counseling, Health Impact Ohio Hub access, cooking classes, and covering delivery fees. It compares this approach to the usual care over six months.

What are the potential side effects?

Since this trial focuses on lifestyle interventions like diet modification and education rather than medication or medical procedures, side effects may include changes in weight or energy levels due to new eating habits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I am enrolled in Medicaid or have dual enrollment in Medicaid.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have an ongoing digestive illness like Celiac or IBS.

Select...

I have a condition that affects my digestion or how I eat.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adherence - Behavioral Nutritional Counseling

Adherence - Health Impact Ohio

Adherence - Mid-Ohio Farmacy

+3 more

Secondary study objectives

Cardiometabolic Health

Dietary Patterns

Nutrition Security

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Intervention GroupExperimental Treatment6 Interventions

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.

Group II: Control GroupExperimental Treatment3 Interventions

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.

0 / 4Eligibility criteria met