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Clinical Trial Summary

The purpose of this study is to determine the processes by which a previously proven lifestyle intervention (the Med-South Lifestyle Program) can most effectively and efficiently be translated into public health and clinical practice to positively impact chronic disease risk reduction among mostly minority, rural, and medically underserved populations.


Clinical Trial Description

Purpose: Although lifestyle behavior change interventions are widely recommended to improve health, they are not being implemented sufficiently or equitably on a national scale, particularly in rural communities. The research team has developed and tested multiple lifestyle interventions, which have culminated in the Med-South Lifestyle Program (MSLP), an evidence-based behavior change intervention that translates the Prevention with Mediterranean Diet (PREDIMED) dietary pattern for a Southeastern US population and includes support for increased physical activity. In this research, the investigators propose to identify the most effective and efficient way to scale-up the MSLP for use in public health and clinical practices settings so that it reaches minority, rural, and medically underserved populations. In Phase 2, the investigators will apply an effectiveness-implementation hybrid design to compare two formats for scaling up MSLP on implementation outcomes (primary aim) and confirm the MSLP's impact on behavioral and clinical outcomes (secondary aim). Participants: Phase II participants include: staff at 20 rural North Carolina sites (10 health departments and 10 federally qualified health centers) and participants from each site (15 each, 300 total) Procedures (methods): Test the effects of scaling up MSLP using two different formats. Using an effectiveness-implementation hybrid Type 3 design, the investigators will randomize 20 sites (10 health departments and 10 Federally Qualified Health Centers (FQHCs)) to 1 of 2 formats for delivering scale up strategies: distance (webinar and phone) vs. a blended in-person/distance collaborative format. Each site will collect data on 15 patients (n=300). Aim 1: Site level: compare the relative effects of the 2 scale-up formats on implementation outcomes (reach, acceptability, feasibility, fidelity, and cost). Aim 2: Participant-level: assess changes in behavioral and clinical outcomes: (1) self-reported diet and physical activity and (2) weight from baseline to follow-up (4 and 10 months). Compare outcomes across the 2 scale-up delivery formats. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05067816
Study type Interventional
Source University of North Carolina, Chapel Hill
Contact Kiira M Lyons, MA
Phone 919-843-9563
Email [email protected]
Status Recruiting
Phase N/A
Start date October 15, 2021
Completion date May 31, 2023

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