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Med-South Lifestyle Program for Healthy Living

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 will test how well a lifestyle intervention can be translated into public health and clinical practice to reduce chronic disease risk in underserved populations.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Eligible Patients Participating
Percentage of Med-South Lifestyle Program Delivered as Intended
Secondary outcome measures
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

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
878 Previous Clinical Trials
22,476,672 Total Patients Enrolled
University of North Carolina, Chapel HillLead Sponsor
1,526 Previous Clinical Trials
4,196,869 Total Patients Enrolled
CARMEN SAMUEL-HODGE, PhDPrincipal InvestigatorUNC at Chapel Hill
~21 spots leftby Sep 2024