Med-South Lifestyle Study: Phase 1
Condition: Healthy Lifestyle
Study type: Interventional

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.
    

Detailed 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 PREDIMED (Mediterranean)
      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 1, the investigators will develop, pilot test, and refine implementation strategies
      that will be used to take the MSLP to scale.

      Participants: Phase I participants include up to 80 participants who will receive the MSLP
      and for whom the study team will collect baseline and follow-up data.

      Procedures (methods): An evidence-based framework for scaling-up health interventions will be
      used to guide Phase I activities. The initial phase involves refining the "scalable unit"
      which includes the lifestyle program (MSLP), implementation strategies for the sites that
      will give the program, and strategies UNC will use to train sites on implementing the
      program. To refine the scalable unit the investigators will apply a descriptive, qualitative
      design to assess the feasibility and acceptability of the MSLP's intervention and
      implementation strategies (i.e., what the investigators will scale-up in Phases 2 and 3). In
      Phase 1, the study team will recruit 2 local health departments and 2 federally qualified
      health centers as participating sites. Each site will form an implementation team of 2-4
      individuals who will go through training on intervention delivery and implementation. Sites
      will be randomized to receive training either through a distance (webinar) or
      in-person/collaborative format. Each site will recruit up to 20 participants (for a total of
      80 across all sites) to receive the intervention.
    

Intervention name(s): Med-South Lifestyle Program
Intervention type(s): Behavioral
Intervention description(s): The Med-South Lifestyle Program is an evidence-based behavior change intervention that translates the PREDIMED (Mediterranean) dietary pattern for a Southeastern US population and includes support for increased physical activity.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention