Dietary and Behavioral Changes for Metabolic Syndrome

(SUSTAIN Trial)

Overseen By Joshua Joseph

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Digestive illnesses, Psychiatric illness, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new program called SUSTAIN can assist individuals with metabolic syndrome and related conditions, such as high blood pressure or type 2 diabetes, through dietary and behavioral changes. Participants receive groceries, nutrition counseling, and support via home deliveries. The trial aims to assess adherence to the program and its impact on health improvement. It seeks individuals on Medicaid who can shop online and receive home deliveries. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance health outcomes for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

What prior data suggests that the SUSTAIN intervention is safe?

Studies have shown that lifestyle programs like SUSTAIN, which involve changes in diet and daily habits, are generally safe for people. Research indicates that these programs can help manage health issues related to metabolism by encouraging healthier eating and more physical activity. In a related study, many participants saw significant improvements in their Metabolic Syndrome (MetS) after making lifestyle changes.

These programs typically avoid medications or complicated medical procedures, making them easy for most people to follow. Reports of serious side effects from similar lifestyle programs are absent, making them a safe choice for those seeking to improve health through diet and behavior changes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a comprehensive lifestyle approach to tackle metabolic syndrome, which is often managed with medications like statins, antihypertensives, and metformin. Unlike standard treatments that focus primarily on medication, this trial emphasizes dietary and behavioral changes. Key features include personalized nutrition counseling, social needs screening, and innovative food access solutions like Instacart vouchers and the Mid-Ohio Farmacy Program. These elements aim to address the root causes of metabolic syndrome, potentially offering a holistic and sustainable way to improve health outcomes.

What evidence suggests that the SUSTAIN intervention could be effective for metabolic syndrome?

Research has shown that lifestyle changes, such as improved diet and increased exercise, can help manage metabolic syndrome. One study found that 22% of participants saw their metabolic syndrome resolve after following a structured lifestyle program. Another study demonstrated that planned diet and exercise programs improved various aspects of metabolic syndrome. This trial will compare the SUSTAIN program, which provides dietary support and behavioral counseling, with a control group receiving standard dietary support. These findings suggest that the SUSTAIN program might effectively treat metabolic syndrome by facilitating lasting lifestyle changes. ^{1 5 6 7 8}

Who Is on the Research Team?

Joshua J Joseph, MD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with hypertension, type 2 diabetes, high cholesterol, kidney disease, or metabolic syndrome.

Patient must have access to internet-enabled device

I am willing to use my credit card for backup payments on Instacart.

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Intervention Phase 1

Participants receive Instacart groceries (voucher + delivery fees), access to the Mid-Ohio Farmacy Program, behavioral nutrition counseling, and social needs screening and referrals

8 weeks

Weekly visits (virtual or in-person)

Intervention Phase 2

Participants receive Instacart groceries (delivery fees only), access to the Mid-Ohio Farmacy Program, behavioral nutrition counseling, and social needs screening and referrals

8 weeks

Weekly visits (virtual or in-person)

Intervention Phase 3

Participants receive Instacart access (no financial support), access to the Mid-Ohio Farmacy Program, and social needs screening and referrals

8 weeks

Weekly visits (virtual or in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• SUSTAIN

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 6 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 Group Experimental Treatment 3 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.

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Published Research Related to This Trial

Metabolic syndrome, characterized by a combination of high triglycerides, low HDL cholesterol, high blood pressure, impaired glucose tolerance, and central obesity, is becoming a leading risk factor for heart disease in the U.S., surpassing smoking.

Effective management of metabolic syndrome includes lifestyle interventions such as diet and exercise, with weight loss improving all aspects of the syndrome; specific dietary changes can target individual risk factors, like reducing saturated fats for insulin resistance and sodium for blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic syndrome: time for action. Deen, D.[2017]

A study involving 71 adults with metabolic syndrome found that those receiving in-depth telephone-delivered nutrition education had significantly greater reductions in weight, body fat, and abdominal circumference compared to those who had a single visit with a dietitian.

After 3 months, the prevalence of metabolic syndrome decreased to 45.5% in the telephone counseling group, compared to 69.7% in the single-visit group, highlighting the effectiveness of ongoing dietary support through phone counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of the telephone-delivered nutrition education on dietary intake and biochemical parameters in subjects with metabolic syndrome. Kim, J., Bea, W., Lee, K., et al.[2021]

The metabolic syndrome is rapidly increasing globally, and effective prevention and treatment focus on lifestyle changes such as a healthy diet and regular physical activity, along with medications targeting specific risk factors.

Weight loss is crucial for improving all aspects of the metabolic syndrome and is a primary target for intervention, with successful long-term management relying on strategies like setting realistic goals and providing support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Need for lifestyle intervention: how to begin. Foreyt, JP.[2018]

The metabolic syndrome, which clusters cardiovascular risk factors, significantly raises the risk of diabetes, kidney disease, and cardiovascular disease, as well as premature death, particularly in older adults and Mexican Americans.

A recent randomized controlled trial showed that a weight loss and exercise intervention reduced the incidence of metabolic syndrome by 41% in individuals with impaired glucose tolerance, highlighting the importance of lifestyle changes in managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidemiology of the metabolic syndrome. Reynolds, K., He, J.[2022]

Lifestyle interventions, such as dietary changes and increased physical activity, can effectively improve or prevent the progression of components of metabolic syndrome, which are early indicators of serious health issues like diabetes and heart disease.

Implementing community-level strategies to promote these lifestyle changes is crucial for public health, as it can empower at-risk populations and potentially delay or prevent the onset of major cardiometabolic disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Principles and practice of nonpharmacological interventions to reduce cardiometabolic risk. Dagogo-Jack, S., Egbuonu, N., Edeoga, C.[2022]

The metabolic syndrome is a serious health condition linked to obesity that raises the risk of diabetes, heart disease, and stroke, highlighting the need for effective management strategies.

Lifestyle changes, including weight loss, dietary modifications, and increased physical activity, are crucial for reversing the effects of metabolic syndrome and improving overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health promotion in older adults: the role of lifestyle in the metabolic syndrome. Firdaus, M., Mathew, MK., Wright, J.[2017]

Weight reduction through a combination of reduced caloric intake and increased physical activity is crucial for individuals with metabolic syndrome, which is linked to a higher risk of atherosclerotic disease and type 2 diabetes.

Adopting a Mediterranean diet, rich in fruits, vegetables, and healthy fats, has been associated with a 25% reduction in the prevalence of metabolic syndrome, making it a promising lifestyle intervention for reducing cardiovascular risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mediterranean diet and the metabolic syndrome. Esposito, K., Ciotola, M., Giugliano, D.[2017]

The metabolic syndrome is a major risk factor for cardiovascular disease, diagnosed based on criteria like obesity, high blood pressure, and insulin resistance, highlighting the need for effective dietary interventions.

Current dietary strategies for managing metabolic syndrome should focus on reducing energy intake, increasing physical activity, and balancing macronutrients, while emphasizing long-term support and group therapy to address individual risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Metabolic syndrome: diagnosis and dietary intervention]. Eisenlohr, H.[2018]

Lifestyle modifications, including weight loss, aerobic exercise, smoking cessation, and improved diet, are crucial first steps in treating metabolic syndrome, as they can enhance insulin resistance and help prevent type 2 diabetes.

Medications like metformin and thiazolidinediones, which reduce insulin resistance, may also be beneficial for individuals with metabolic syndrome as a preventive strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic syndrome: are we at risk? Paudel, B.[2017]

A 6-month lifestyle intervention involving dietary and physical activity counseling significantly improved BMI and waist circumference in patients with metabolic syndrome, particularly in the 'Increase' and 'Increase - Decrease' groups compared to the 'Minimum Intervention' group.

The 'Increase - Decrease' group also showed significant reductions in blood pressure and glucose levels, with 48% of participants no longer meeting the criteria for metabolic syndrome, highlighting the effectiveness of a comprehensive approach to dietary changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting only the consumption of healthy foods may be an alternative stategy for treating patients with the metabolic syndrome. Fappa, E., Yannakoulia, M., Skoumas, Y., et al.[2017]

Citations

1. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2841069

Lifestyle Intervention for Sustained Remission of Metabolic ... They achieved, on average, 22% MetS remission using lifestyle treatments that continued at various levels of intensity over the duration of the ...

2. withpower.com withpower.com/trial/phase-metabolic-syndrome-7-2024-2112f

Dietary and Behavioral Changes for Metabolic Syndrome What data supports the effectiveness of the treatment SUSTAIN for metabolic syndrome? The research highlights that lifestyle changes, including diet and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6244588/

Long-term outcomes following completion of a structured ... Studies have demonstrated the effectiveness of structured diet and exercise programs to improve the components of metabolic syndrome. The ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04036006

Enhanced Lifestyles for Metabolic Syndrome (ELM) This is a multi-center behavioral randomized trial with the aim of comparing a group-based lifestyle intervention with a self-directed lifestyle intervention.

5. edhub.ama-assn.org edhub.ama-assn.org/jn-learning/audio-player/19016173

Lifestyle Intervention for Sustained Remission of Metabolic ... The authors of the Enhanced Lifestyles for Metabolic Syndrome or ELM trial focused on four simple habits - brisk walking, eating vegetables, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3047997/

Lifestyle modification in the management of the metabolic ... Promising results have been achieved by combining lifestyle modification with pharmacotherapy, using meals replacement, setting higher physical activity goals, ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2772487525001175

Sustainable effects of a hybrid self-care education program ... This study evaluated the long-term effectiveness of a self-care education program combining the teach-back method with a digital application, focusing on ...

8. mdpi.com mdpi.com/2072-6643/17/7/1257

The Impact of Dietary Interventions on Metabolic Outcomes ... Objectives: This systematic review aims to investigate the impact of model dietary patterns on metabolic outcomes in patients with MASLD and evaluate their ...