Med-South Lifestyle Program Implementation Study

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

NCT05067816

21-1281

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 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.

Enrollment: 368 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female
• English speaking (Spanish-speaking only in selected sites with bilingual staff)
• 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)

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368 participants in 2 patient groups

Distance Scale-Up Format

Active Comparator group

Description:

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:

Behavioral: Med-South Lifestyle Program

Quality Improvement Collaborative Scale-Up Format

Experimental group

Description:

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.

Treatment:

Behavioral: Med-South Lifestyle Program