Lifestyle Interventions for Neurological Disorders

(MINDS Trial)

Overseen By Suman Kundu, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vineet Punia MD

Disqualifiers: Chronic illness, Intensive treatment, Pregnancy, Hearing loss, Vision impairment, others

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

Compensation: Varies

Number of Visits: 15

200 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if a mix of healthy activities and education can help people at risk of neurological disorders. Participants will do brain exercises, yoga, music therapy, and follow a healthy diet. The goal is to see if these activities can keep their brains healthier and delay or prevent neurological issues.

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's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Multidisciplinary Lifestyle Interventions (MLI) for neurological disorders?

Research shows that a similar multidisciplinary lifestyle intervention improved physical activity, reduced health risks, and enhanced psychosocial functioning in patients with severe mental illness. This suggests that MLI could also be beneficial for neurological disorders by promoting healthier lifestyles and improving overall health. ^{1 2 3 4 5}

How is the Multidisciplinary Lifestyle Interventions treatment different from other treatments for neurological disorders?

Multidisciplinary Lifestyle Interventions (MLI) are unique because they focus on modifying lifestyle behaviors such as diet, physical activity, and smoking cessation, which can help manage neurological disorders. Unlike standard treatments that may rely on medication, MLI emphasizes behavior change techniques and education to empower patients to make healthier lifestyle choices. ^{6 7 8 9 10}

Research Team

Vineet Punia, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

This trial is for neurologically healthy individuals over 50, or relatives over 20 of MS patients, who are at risk of neurological disorders. They must be part of the Cleveland Clinic Brain Study and show early signs like smell loss, MRI changes, EEG abnormalities, memory issues or multiple brain lesions.

Inclusion Criteria

I am willing to undergo regular and detailed health checks including blood tests and scans.

I am at risk for stroke, epilepsy, movement disorder, or dementia but do not have a neurological disease.

Participants must be enrolled in Cleveland Clinic Brain Study (CCBS)

Exclusion Criteria

I have significant hearing loss.

Participants who are actively engaged in 2 or more of the study interventions

I am not undergoing any intense treatments for a serious illness that would affect my participation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive weekly, instructor-led intervention sessions (virtual group sessions) for 12 weeks

12 weeks

12 virtual group sessions

Self-practice

Participants practice learned interventions on their own for nine months

9 months

Monthly check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

3 visits (in-person) at enrollment, 12 weeks, and 12 months

Treatment Details

Interventions

• Multidisciplinary Lifestyle Interventions

Trial Overview The study tests if lifestyle interventions can slow down or reverse neurological disorder symptoms. Participants will either receive weekly virtual sessions on lifestyle changes for three months followed by self-practice or they'll be observed without intervention.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

Multidisciplinary lifestyle interventions will be provided weekly for 12 weeks after enrollment.

Group II: Control Active Control 1 Intervention

No intervention. Periodic check-ups will be performed during the first 12 weeks, followed by monthly check-ins like the intervention arm.

Who Is Running the Clinical Trial?

Vineet Punia MD

Lead Sponsor

Trials

1

Recruited

200+

Ohio Department of higher education

Collaborator

Trials

1

Recruited

200+

Findings from Research

A multidisciplinary lifestyle enhancement treatment (MULTI) significantly improved physical activity, cardiometabolic risk factors, and psychosocial functioning in inpatients with severe mental illness (SMI) after 18 months, compared to standard treatment (TAU).

The implementation of MULTI faced challenges due to organizational factors, but was supported by positive attitudes from both healthcare professionals and patients, highlighting the importance of engagement in lifestyle changes for improving health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Thinking inside the box: improving the lifestyle of inpatients with severe mental illness]. Deenik, J., Tenback, DE., Tak, ECPM., et al.[2021]

Type 2 diabetes affects a significant portion of the American population, with lifestyle interventions being crucial for both initial treatment and ongoing management.

Effective management of type 2 diabetes includes a combination of healthy eating, physical activity, medication, and patient education to help control glucose, lipid levels, and blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle intervention: nutrition therapy and physical activity. Evert, AB., Riddell, MC.[2014]

Following a confirmed diagnosis, it is important to recommend lifestyle adjustments to improve health outcomes.

In specific clinical situations, medical therapy may also be necessary to effectively manage the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Getting hypertension under control in the youngest of patients. Smith, DK., McMullan, SM., Martin, MJ.[2021]

The CURIAMO project involves a multidisciplinary lifestyle intervention for obesity and Type 2 diabetes, engaging around 1000 adults over a 3-year period, with a focus on achieving significant weight loss and increased physical activity.

The intervention aims for at least 70% of participants to lose 7% of their body weight and increase their physical activity by 10 MET/h-1·week-1 after one year, indicating a strong potential for long-term health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An innovative model for changing the lifestyles of persons with obesity and/or Type 2 diabetes mellitus. De Feo, P., Fatone, C., Burani, P., et al.[2021]

The MULTI_sh lifestyle intervention did not lead to significant health improvements for people with severe mental illness living in sheltered housing, as shown in a study involving 74 participants over 12 months.

Implementation of MULTI_sh faced challenges due to organizational factors like staff shortages and complexity, indicating that successful lifestyle interventions require better support and strategies at the organizational level.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the implementation of a multidisciplinary lifestyle intervention for people with severe mental illness in sheltered housing: effectiveness-implementation hybrid randomised controlled trial. Smit, MMC., Waal, E., Tenback, DE., et al.[2022]

This review aims to identify and analyze various dietary education programs for adults with neurological diseases, which affect up to 1 billion people, including conditions like Alzheimer's and Parkinson's disease.

The review will evaluate program characteristics such as duration, session length, and behavior change techniques, providing insights into effective dietary interventions recommended by the World Health Organization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary education programs for adults with neurological diseases: a scoping review protocol. Russell, RD., Black, LJ., Begley, A.[2022]

Plant-based, low-fat, high-fiber diets rich in antioxidants may help reduce the impact of common neurological disorders like Alzheimer's and Parkinson's disease by addressing underlying issues such as oxidative stress and neuroinflammation.

The ketogenic diet is particularly effective for treating refractory epilepsy, highlighting how specific dietary interventions can target the metabolic disruptions associated with various neurological conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Insights in Neurological Diseases. Ramírez-Salazar, SA., Herren, C., McCartney, J., et al.[2021]

A scoping review of 2555 articles identified only 13 nutrition education programs for adults with neurological diseases, indicating a significant gap in available resources for conditions like dementia, multiple sclerosis, and stroke.

Most programs lacked adherence to best practice principles in nutrition education, such as structured delivery and evaluation methods, highlighting the need for more effective and evidence-based programs to support dietary adherence in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition Education Programs for Adults with Neurological Diseases Are Lacking: A Scoping Review. Russell, RD., Black, LJ., Begley, A.[2022]

Recurrent strokes account for 23% of nearly 800,000 annual strokes, leading to higher risks of disability and mortality, highlighting the critical need for effective secondary stroke prevention strategies.

Modifiable risk factors such as diet, physical activity, smoking cessation, and alcohol consumption can significantly reduce stroke risk, and while lifestyle changes can be challenging for stroke survivors, targeted interventions and support can facilitate these modifications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle Modification for Secondary Stroke Prevention. Bailey, RR.[2023]

A 24-week lifestyle intervention, including exercise training and dietary changes, significantly improved physical activity and reduced salt intake in patients with noncardioembolic mild ischemic stroke, leading to better vascular risk factors like lower blood pressure and higher HDL cholesterol levels.

After nearly 3 years of follow-up, the lifestyle intervention group had significantly fewer new vascular events compared to the control group, indicating that lifestyle changes can effectively reduce the risk of future strokes and other vascular issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secondary prevention of new vascular events with lifestyle intervention in patients with noncardioembolic mild ischemic stroke: a single-center randomized controlled trial. Kono, Y., Yamada, S., Yamaguchi, J., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

[Thinking inside the box: improving the lifestyle of inpatients with severe mental illness]. [2021]

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

Lifestyle intervention: nutrition therapy and physical activity. [2014]

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

Getting hypertension under control in the youngest of patients. [2021]

4. Italy pubmed.ncbi.nlm.nih.gov

An innovative model for changing the lifestyles of persons with obesity and/or Type 2 diabetes mellitus. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Evaluating the implementation of a multidisciplinary lifestyle intervention for people with severe mental illness in sheltered housing: effectiveness-implementation hybrid randomised controlled trial. [2022]

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

Dietary education programs for adults with neurological diseases: a scoping review protocol. [2022]

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

Dietary Insights in Neurological Diseases. [2021]

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

Nutrition Education Programs for Adults with Neurological Diseases Are Lacking: A Scoping Review. [2022]

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

Lifestyle Modification for Secondary Stroke Prevention. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Secondary prevention of new vascular events with lifestyle intervention in patients with noncardioembolic mild ischemic stroke: a single-center randomized controlled trial. [2022]