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Med-South Lifestyle Program for Healthy Lifestyle

Q: Is it possible for me to join this trial?

The research team is hoping to enrol 380 individuals between 18 and 80 years old, who exhibit healthy lifestyle practices. The applicants must be of either gender within the specified age range.

Q: What are the desired end-results of this experiment?

This 10-month study seeks to measure the proportion of eligible participants that take part. Secondary objectives include determining changes in daily fruit and vegetable servings (measured using a 1-5 scale), mean weight change as a percentage, and systolic blood pressure at end of 4 months measured via the Med-South Program.

Q: Does the enrollment criteria for this experiment extend to those below octogenarian age?

This research protocol necessitates that participants are between 18 to 80 years of age. There are 10 trials for minors and 31 for those over the retirementable age.

Q: Are there any opportunities to enroll in this experiment currently?

The information found on clinicaltrials.gov suggests that this particular trial is no longer accepting new participants. Originally posted on October 26th 2021, the study was last updated on May 13th 2022; however, 45 other trials are still actively recruiting patients at present.

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

Study 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 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

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor

1,508 Previous Clinical Trials

4,190,674 Total Patients Enrolled

Centers for Disease Control and PreventionFED

875 Previous Clinical Trials

22,477,034 Total Patients Enrolled

Carmen Samuel-Hodge, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

1 Previous Clinical Trials

36 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to join this trial?

"The research team is hoping to enrol 380 individuals between 18 and 80 years old, who exhibit healthy lifestyle practices. The applicants must be of either gender within the specified age range."

Answered by AI

What are the desired end-results of this experiment?

"This 10-month study seeks to measure the proportion of eligible participants that take part. Secondary objectives include determining changes in daily fruit and vegetable servings (measured using a 1-5 scale), mean weight change as a percentage, and systolic blood pressure at end of 4 months measured via the Med-South Program."

Answered by AI

Does the enrollment criteria for this experiment extend to those below octogenarian age?

"This research protocol necessitates that participants are between 18 to 80 years of age. There are 10 trials for minors and 31 for those over the retirementable age."

Answered by AI

Are there any opportunities to enroll in this experiment currently?

"The information found on clinicaltrials.gov suggests that this particular trial is no longer accepting new participants. Originally posted on October 26th 2021, the study was last updated on May 13th 2022; however, 45 other trials are still actively recruiting patients at present."

Answered by AI

Recent research and studies

BMC Public HealthJournal

A Community-based Lifestyle and Weight Loss Intervention Promoting a Mediterranean-style Diet Pattern Evaluated in the Stroke Belt of North Carolina: The Heart Healthy Lenoir Project

Keyserling, Thomas C., Carmen D. Samuel-Hodge, Stephanie Jilcott Pitts, Beverly A. Garcia, Larry F. Johnston, Ziya Gizlice, Cassandra L. Miller, et al.. 2016. “A Community-based Lifestyle and Weight Loss Intervention Promoting a Mediterranean-style Diet Pattern Evaluated in the Stroke Belt of North Carolina: The Heart Healthy Lenoir Project”. BMC Public Health. Springer Science and Business Media LLC. doi:10.1186/s12889-016-3370-9.

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Understanding Quality Improvement Collaboratives Through an Implementation Science Lens

Rohweder, Catherine, Mary Wangen, Molly Black, Heather Dolinger, Marti Wolf, Carey O'Reilly, Heather Brandt, and Jennifer Leeman. 2019. “Understanding Quality Improvement Collaboratives Through an Implementation Science Lens”. Preventive Medicine. Elsevier BV. doi:10.1016/j.ypmed.2019.105859.

Implementation ScienceJournal

What Strategies Are Used to Build Practitioners’ Capacity to Implement Community-based Interventions and Are They Effective?: A Systematic Review

Leeman, Jennifer, Larissa Calancie, Marieke A. Hartman, Cam T. Escoffery, Alison K. Herrmann, Lindsay E. Tague, Alexis A. Moore, Katherine M. Wilson, Michelle Schreiner, and Carmen Samuel-Hodge. 2015. “What Strategies Are Used to Build Practitioners’ Capacity to Implement Community-based Interventions and Are They Effective?: A Systematic Review”. Implementation Science. Springer Science and Business Media LLC. doi:10.1186/s13012-015-0272-7.

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