What side effects are associated with this type of intervention?

Common treatments for a healthy lifestyle, such as those in the Med-South Lifestyle Program, generally include dietary changes and increased physical activity. Dietary changes can lead to gastrointestinal discomfort, including bloating, gas, and changes in bowel habits, particularly with increased fiber intake. Physical activity may result in muscle soreness, fatigue, and potential injury if not performed correctly. Behavioral modifications, like stress management techniques, typically have minimal side effects but may cause temporary emotional discomfort during the adjustment period.

What prior FDA approvals exist?

The FDA has not specifically approved lifestyle programs like the Med-South Lifestyle Program, which focuses on diet and physical activity to reduce chronic disease risk. However, the FDA has approved various medications and interventions aimed at supporting weight loss and managing chronic conditions such as diabetes and hypertension, which can complement lifestyle changes. For example, drugs like orlistat and liraglutide have been approved for weight management, while medications such as metformin are used to manage blood glucose levels in diabetes. These pharmacological treatments can be part of a comprehensive approach that includes lifestyle modifications to improve overall health.

What other types of research exist?

<ol> <li>Plant-Based Nutrition Program: This program includes weekly nutrition education, peer mentoring, and support, and has shown improvements in plasma cholesterol levels, hemoglobin A1C, blood pressure, body weight, and reduced healthcare utilization.</li> <li></li> </ol> Mediterranean Diet (MedDiet) Interventions: Studies have shown high adherence and significant health benefits, including reduced mortality and improved outcomes in chronic disease management. 3. Behavioral Weight Loss Programs: These programs often include dietary therapy, physical activity, and behavioral counseling, and have demonstrated effectiveness in weight loss and maintenance, as well as improvements in metabolic health markers.

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Med-South Lifestyle Program for Healthy Living

Q: What is the mechanism of action of this treatment?

The Med-South Lifestyle Program focuses on dietary changes and increased physical activity to reduce chronic disease risk. The primary mechanisms of action include improving metabolic health through balanced nutrition, which can lower blood pressure, reduce cholesterol levels, and improve blood sugar control. Physical activity enhances cardiovascular health, aids in weight management, and improves insulin sensitivity. These lifestyle changes are crucial for patients as they not only help in managing weight but also significantly reduce the risk of chronic diseases such as diabetes, hypertension, and cardiovascular diseases, thereby promoting overall health and longevity.

N/A

Waitlist Available

Led By CARMEN SAMUEL-HODGE, PhD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 4, month 10

Awards & highlights

Summary

This trial aims to find the best way to use the Med-South Lifestyle Program, which promotes healthy eating and exercise, to help minority, rural, and underserved communities in North Carolina reduce their risk of chronic diseases.

Who is the study for?

This trial is for men and women aged 18-80 who speak English, aiming to adopt a healthier lifestyle. It's especially focused on minority, rural, and underserved groups. People with cancer or advanced kidney disease (creatinine clearance <30 mL/min) cannot participate.

What is being tested?

The study is testing the Med-South Lifestyle Program to see how it can be best applied in public health and clinical settings to reduce chronic disease risk among diverse populations.

What are the potential side effects?

Since this program promotes a healthy lifestyle rather than medication, typical drug side effects are not expected. Participants may experience changes related to diet and exercise adjustments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 4, month 10

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 4, month 10

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 4, month 10 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percentage of Eligible Patients Participating

Percentage of Med-South Lifestyle Program Delivered as Intended

Secondary study objectives

Mean Change in Diastolic Blood Pressure at end of 4-Month Med-South Program

Mean Change in Diastolic Blood Pressure at end of 6-Month Maintenance Phase

Mean Change in Minutes of Physical Activity Per Week

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Quality Improvement Collaborative Scale-Up FormatExperimental Treatment1 Intervention

10 sites with up to 150 program participants will be randomly assigned to a quality improvement collaborative scale-up format where implementation teams will work collaboratively during training and implementation. All implementation training will occur using a virtual web-based format. Implementation teams will receive 8 hours of web-conferences, 2 hours of online training, and 4 hours of technical assistance.

Group II: Distance Scale-Up FormatActive Control1 Intervention

10 sites with up to 150 program participants will be randomly assigned to a distance scale-up format where each site implementation team will receive technical assistance individually. All implementation training will occur using a virtual web-based format. Implementation teams will receive 8 hours of web-conferences, 2 hours of online training, and 4 hours of technical assistance.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Med-South Lifestyle Program

2020

N/A

~40

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Med-South Lifestyle Program focuses on dietary changes and increased physical activity to reduce chronic disease risk. The primary mechanisms of action include improving metabolic health through balanced nutrition, which can lower blood pressure, reduce cholesterol levels, and improve blood sugar control. Physical activity enhances cardiovascular health, aids in weight management, and improves insulin sensitivity. These lifestyle changes are crucial for patients as they not only help in managing weight but also significantly reduce the risk of chronic diseases such as diabetes, hypertension, and cardiovascular diseases, thereby promoting overall health and longevity.

Mediterranean diet and other lifestyle factors in relation to 20-year all-cause mortality: a cohort study in an Italian population.Diet and prostate cancer: mechanisms of action and implications for chemoprevention.Health professionals' advice to Iowa adults with hypertension using the 2002 Behavioral Risk Factor Surveillance System.

Find a Location

Who is running the clinical trial?

Centers for Disease Control and PreventionFED

882 Previous Clinical Trials

22,474,617 Total Patients Enrolled

University of North Carolina, Chapel HillLead Sponsor

1,543 Previous Clinical Trials

4,248,674 Total Patients Enrolled

CARMEN SAMUEL-HODGE, PhDPrincipal InvestigatorUNC at Chapel Hill

~0 spots leftby Sep 2024

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