Med-South Lifestyle Study: Phase 1

University of North Carolina (UNC) logo

University of North Carolina (UNC)

Status

Completed

Conditions

Healthy Lifestyle

Treatments

Behavioral: Med-South Lifestyle Program

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT04421703
19-2079

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Male or female
  • English speaking
  • Ages 18-80

Exclusion criteria

  • Malignancy
  • Advanced kidney disease (estimated creatinine clearance < 30 mL/min)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

36 participants in 2 patient groups

Distance Collaborative
Experimental group
Description:
For sites randomized to the distance arm, training will be delivered via web conference, and technical assistance and assessment and feedback will be delivered by phone.
Treatment:
Behavioral: Med-South Lifestyle Program
Blended in-person/distance collaborative
Experimental group
Description:
For the QI collaborative arm, training will be delivered in two in-person collaborative meetings; and the remainder of the strategies will be delivered via web-conferencing.
Treatment:
Behavioral: Med-South Lifestyle Program

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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