Med-South Lifestyle Study: Phase 1

November 6, 2023 updated by: University of North Carolina, Chapel Hill

Scaling up the Med-South Lifestyle Program to Reduce Chronic Disease in Partnership With Rural Communities: Phase 1

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Norlina, North Carolina, United States, 27563
        • Rural Health Group
      • Oxford, North Carolina, United States, 27565
        • Granville-Vance Public Health
      • Roxboro, North Carolina, United States, 27573
        • Person Family Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Distance Collaborative
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.
Behavioral: Med-South Lifestyle Program
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.
Experimental: Blended in-person/distance collaborative
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.
Behavioral: Med-South Lifestyle Program
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Eligible Patients Participating
Time Frame: Month 6
Percentage of each setting's eligible patients who participate in the Med-South Lifestyle Program and the representativeness of participants (age, gender, race/ethnicity) as compared to overall population of eligible patients.
Month 6
Percentage of Med-South Lifestyle Program Delivered as Intended
Time Frame: Month 6
To determine delivery fidelity, the study team will measure the degree to which the intervention is delivered as intended as assessed by direct observations and audio file reviews documented by checklist.
Month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change Number of Fruit and Vegetable Servings Per Day
Time Frame: Baseline, Month 6

The mean difference in fruit and vegetable servings per day (baseline servings/day - follow-up servings/day) as measured by the Block Fruit-Vegetable-Fiber Screener.

The Block Fruit-Vegetable-Fiber Screener is a 10-item scale with responses ranging from: (1) Less than 1/week to (5) 2+ a day. Higher scores reflect a better outcome.
Baseline, Month 6
Mean Change in Minutes of Physical Activity Per Week
Time Frame: Baseline, Month 6
Mean difference in minutes of physical activity per week (baseline activity in minutes/week - follow-up activity in minutes/week) as measured by the validated modified RESIDE questionnaire. The RESIDE questionnaire is a 21-item self-administered instrument in which participants recall the frequency, duration, and destination of their walking (for transport and recreation) within and outside of their neighborhood, and cycling activity in a usual week. Higher scores indicate more minutes of activity.
Baseline, Month 6
Mean Percent Change in Weight
Time Frame: Baseline, Month 6
Mean weight change (in kg) from baseline to follow-up expressed as a percentage.
Baseline, Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Carmen Samuel-Hodge, PhD, UNC Chapel Hill
  • Principal Investigator: Jennifer Leeman, DrPH, UNC Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

December 15, 2021

Study Completion (Actual)

December 15, 2021

Study Registration Dates

First Submitted

May 7, 2020

First Submitted That Met QC Criteria

June 4, 2020

First Posted (Actual)

June 9, 2020

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 6, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 19-2079

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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