Dietary and Behavioral Changes for Metabolic Syndrome

(SUSTAIN Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Joshua J Joseph, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Ohio State University

Disqualifiers: Digestive illnesses, Psychiatric illness, Pregnancy, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment SUSTAIN for metabolic syndrome?

The research highlights that lifestyle changes, including diet and exercise, are effective in improving metabolic syndrome. These changes can reduce weight, improve blood pressure, and lower cholesterol levels, which are key components of metabolic syndrome.

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Is the treatment for metabolic syndrome safe for humans?

Lifestyle changes like diet and exercise, which are part of the treatment for metabolic syndrome, are generally safe and have been shown to improve health by reducing risk factors like high blood pressure and high cholesterol.

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How does the SUSTAIN treatment differ from other treatments for metabolic syndrome?

The SUSTAIN treatment is unique because it focuses on dietary and behavioral changes to address metabolic syndrome, emphasizing lifestyle modifications like diet and exercise, which can significantly improve or even reverse the condition. Unlike some treatments that rely on medication, SUSTAIN targets the root behavioral causes of metabolic syndrome, promoting long-term health improvements through sustainable lifestyle changes.

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Eligibility Criteria

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 18 years old or older.

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

Trial Timeline

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)

Participant Groups

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.

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

The Ohio State University Wexner Medical Center Columbus, OH

Who Is Running the Clinical Trial?

Ohio State University Lead Sponsor

American Heart Association Collaborator

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Metabolic syndrome: diagnosis and dietary intervention]. [2018] The metabolic syndrome is diagnosed according to criteria set by either WHO (obesity, high blood pressure, dyslipidemia, insulin resistance) or more recently by ATP III (National Cholesterol Education Program's Adult Treatment Panel III report). The latter emphasizes abdominal obesity, atherogenic dyslipidemia, high blood pressure and increased fasting glucose. Without presuming a nosologic entity, the metabolic syndrome is emerging as by far the most important precursor of an epidemic of cardiovascular disease, not only in Western countries. This epidemic calls for action at a time when our understanding of dietary intervention for maintaining weight loss remains primitive and cannot withstand critical scrutiny (because of a lack of long term randomised, prospective studies). Dietary therapy in metabolic syndrome therefore has to be aimed where success is most likely, i.e. at a reduction in energy intake and increase in output by physical activity, a prudent balance of carbohydrates, proteins and fats, taking into account secondary changes in lipid profiles and the glycemic load of nutrients. All nutritional advice must be incorporated in long term programs with continuous guidance, preferably in group therapy targeting all individual risk factors.

2. United States pubmed.ncbi.nlm.nih.gov

Need for lifestyle intervention: how to begin. [2018] The metabolic syndrome is the fastest growing disease entity in the world. Prevention and effective treatment emphasize lifestyle intervention, including healthful diet, physical activity, and pharmacologic agents to target specific risk factors. Weight loss improves all aspects of the metabolic syndrome and is a primary intervention target. Effective weight management also helps prevent the development of the metabolic syndrome. Lifestyle change strategies--including setting reasonable goals, raising awareness, confronting barriers to change, managing stress, cognitive restructuring, preventing relapse, and providing support--are the keys to long-term success.

3. United States pubmed.ncbi.nlm.nih.gov

Metabolic syndrome: time for action. [2017] The constellation of dyslipidemia (hypertriglyceridemia and low levels of high-density lipoprotein cholesterol), elevated blood pressure, impaired glucose tolerance, and central obesity is identified now as metabolic syndrome, also called syndrome X. Soon, metabolic syndrome will overtake cigarette smoking as the number one risk factor for heart disease among the U.S. population. The National Cholesterol Education Program-Adult Treatment Panel III has identified metabolic syndrome as an indication for vigorous lifestyle intervention. Effective interventions include diet, exercise, and judicious use of pharmacologic agents to address specific risk factors. Weight loss significantly improves all aspects of metabolic syndrome. Increasing physical activity and decreasing caloric intake by reducing portion sizes will improve metabolic syndrome abnormalities, even in the absence of weight loss. Specific dietary changes that are appropriate for addressing different aspects of the syndrome include reducing saturated fat intake to lower insulin resistance, reducing sodium intake to lower blood pressure, and reducing high-glycemic-index carbohydrate intake to lower triglyceride levels. A diet that includes more fruits, vegetables, whole grains, monounsaturated fats, and low-fat dairy products will benefit most patients with metabolic syndrome. Family physicians can be more effective in helping patients to change their lifestyle behaviors by assessing each patient for the presence of specific risk factors, clearly communicating these risk factors to patients, identifying appropriate interventions to address specific risks, and assisting patients in identifying barriers to behavior change.

4. United States pubmed.ncbi.nlm.nih.gov

Health promotion in older adults: the role of lifestyle in the metabolic syndrome. [2017] The metabolic syndrome, also known as dysmetabolic syndrome, Syndrome X, or insulin resistance syndrome, is an amalgam of obesity-related health risks that significantly increases the chance of developing diabetes, coronary artery disease, and stroke. Progress in understanding the metabolic syndrome has confirmed the importance of metabolic imbalances in the development of serious and chronic cardiovascular, neurologic, immunologic, renal, and endocrine diseases. Crucial to planning treatment is the understanding that the metabolic syndrome is largely a disorder caused by behavior, thus its most important therapeutic intervention entails lifestyle change: Significant behavioral change can dramatically modify and even reverse all factors of the metabolic syndrome and its consequences. We examine the pathophysiology of the metabolic syndrome and provide strategies to encourage weight loss and dietary modifications and to promote increased physical activity.

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Effect of the telephone-delivered nutrition education on dietary intake and biochemical parameters in subjects with metabolic syndrome. [2021] As prevalence of metabolic syndrome has rapidly increased over the past decade, lifestyle changes including dietary habits are considered as a therapeutic cornerstone for metabolic syndrome, cardiovascular complications and type 2 diabetes. We evaluated the effectiveness of a telephone-delivered nutrition education to improve metabolic parameters compared with a single-visit with a dietitian in subjects with metabolic syndrome. A total of seventy-one adults who met diagnostic criteria for the metabolic syndrome were randomly assigned to either the single-visit group or the in-depth nutrition education group during a 3-month intervention study period. The in-depth telephone-delivered nutrition education group had an initial visit with a dietitian and additional two telephone counseling during the first 4 weeks of the study periods. Sixty-six subjects completed a 3-month intervention study. The trial examined participant's anthropometric changes and dietary intakes as well as changes in the metabolic syndrome factors. At the end of the trial, the in-depth nutrition education group showed significantly higher reduction in weight, body fat and abdominal circumference compared with the other group (p

6. Germany pubmed.ncbi.nlm.nih.gov

Mediterranean diet and the metabolic syndrome. [2017] The metabolic syndrome (also referred to as syndrome X or the insulin resistance syndrome) has emerged as an important cluster of risk factors for atherosclerotic disease. Patients with the syndrome also are at increased risk for developing type 2 diabetes mellitus. Common features are central (abdominal) obesity, insulin resistance, hypertension, and dyslipidemia. Weight reduction deserves first priority in individuals with abdominal obesity and the metabolic syndrome. Both weight reduction and maintenance of a lower weight are best achieved by a combination of reduced caloric intake and increased physical activity. Dietary patterns close to the Mediterranean diet and rich in fruit and vegetables, and high in monounsaturated fats are negatively associated with features of the metabolic syndrome. Some recent studies dealing specifically with the effect of interventions on the resolution of the metabolic syndrome have demonstrated a 25% net reduction in the prevalence of the syndrome following lifestyle changes mainly based on nutritional recommendations. Similar rates of resolution have been obtained with drugs, such as rosiglitazone and rimonabant. The favourable benefit/hazard ratio makes Mediterranean-style diets particularly promising to reduce the cardiovascular burden associated with the metabolic syndrome.

7. United States pubmed.ncbi.nlm.nih.gov

Epidemiology of the metabolic syndrome. [2022] The clustering of cardiovascular risk factors, known as the metabolic syndrome, greatly increases the risk of developing diabetes, kidney disease, and cardiovascular disease. Individuals with the metabolic syndrome are also at increased risk for premature death from cardiovascular disease or all-cause mortality. Cross-sectional and longitudinal epidemiologic studies provide prevalence data on the syndrome based on criteria proposed by the World Health Organization and the National Cholesterol Education Program Adult Treatment Panel III. Owing to differences in the criteria, estimates of the prevalence of the syndrome vary according to the criteria used. Generally, the syndrome is more common in older people and in the United States and it is more prevalent among Mexican Americans. Obesity and sedentary lifestyles are major contributing factors to the syndrome and provide opportunities for interventions. Recent data from a randomized controlled trial indicate that a weight loss and exercise intervention reduced the incidence of the metabolic syndrome by 41% among individuals with impaired glucose tolerance. Pharmacologic treatment of the individual components of the metabolic syndrome provides an alternate strategy for managing the syndrome. The rising global epidemics of overweight and obesity will likely lead to increases in the prevalence of the metabolic syndrome posing a serious burden for clinicians and public health officials.

8. Switzerland pubmed.ncbi.nlm.nih.gov

Principles and practice of nonpharmacological interventions to reduce cardiometabolic risk. [2022] The components of the metabolic syndrome, including prediabetes, prehypertension and dyslipidemia, represent prodromal stages of major cardiometabolic disorders. Lifestyle interventions have been shown to ameliorate or prevent the progression of individual components of the metabolic syndrome. The specific interventions utilized in randomized controlled studies often include dietary modification and physical activity. The effects of smoking cessation and the reduction of psychosocial stress on cardiometabolic risk factors need to be studied more. Because of the close concordance between the metabolic syndrome and multiple cardiometabolic diseases, the adoption of an effective lifestyle change upon initial recognition of the metabolic syndrome can be expected to delay or prevent the future development of sequelae such as diabetes, hypertension, and atherosclerotic cardiovascular and cerebrovascular diseases. Such a nonpharmacological approach to primary prevention and disease interruption carries enormous public health significance. Meeting the challenge of an implementation of effective lifestyle change at the community level requires (a) a system for the identification of at-risk populations, (b) an optimization of the knowledge base and practices of health care providers, and (c) a piloting of targeted biobehavioral intervention programs. Once identified, persons and communities at risk for cardiometabolic disorders can be empowered through increased health and nutritional literacy, the promotion of lifestyle interventions, provision of community resources, and pertinent legislative action that rewards preventive behavior. This paper reviews landmark studies that demonstrate the principles of nonpharmacological approaches to the reduction of cardiometabolic risk. We also discuss the physiological and emerging molecular genetic mechanisms that underlie the efficacy of lifestyle interventions.

9. United States pubmed.ncbi.nlm.nih.gov

Promoting only the consumption of healthy foods may be an alternative stategy for treating patients with the metabolic syndrome. [2017] To evaluate the effectiveness of two lifestyle, interventional approaches on metabolic abnormalities and eating habits of patients with metabolic syndrome.

10. Nepal pubmed.ncbi.nlm.nih.gov

Metabolic syndrome: are we at risk? [2017] The metabolic syndrome also called syndrome X, is a constellation of interrelated risk factors of metabolic origin--metabolic risk factors--that appear to share insulin resistance as a possible pathogenetic factor that directly promote the development of atherosclerotic cardiovascular diseases and increase the risk for developing type 2 diabetes mellitus. The recommended first step for treatment of metabolic syndrome is lifestyle modifications such as weight loss, aerobic exercise, smoking cessation, and improved diet which independently improve insulin resistance and slow progression to type 2 diabetes mellitus. Even though success achieved through lifestyle modification is limited, the significance of it cannot be overemphasized. Specific dietary changes that are appropriate for addressing different aspects of the syndrome include reducing saturated fat intake to lower insulin resistance, reducing sodium intake to lower blood pressure, and reducing high-glycemic-index carbohydrate intake to lower triglyceride levels. Furthermore, drugs able to reduce insulin resistance, such as metformin and thiazolidinediones, already in the therapeutic armamentarium of type 2 diabetes, could be used in subjects with the metabolic syndrome as a preventive measure.