Skip to main content
OpenTrials
Completed

NCT Number: NCT05067816

Med-South Lifestyle Program Implementation Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Lifestyle

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNC Chapel Hill

Chapel Hill, North Carolina, 27514, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Med-South Lifestyle Program

Behavioral

The Med-South Lifestyle Program (MSLP) 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. To promote healthy dietary intake and increased physical activity, the intervention incorporates theory-based behavioral approaches targeting self-efficacy, self-regulation, and internal motivation. The MSLP is delivered in 4 monthly counseling sessions with 3 interim phone follow-up contacts. A maintenance phase lasting 6 months follows the 4-month MSLP and includes 2 phone contacts about 2 months apart. Participants are counseled individually, with 2 in-person counseling visits (at the 1st and 4th counseling visit) and 5 total phone contacts. Each participant is provided with program materials in a participant manual, a cookbook, and a local resource manual identifying community resources to support making targeted behavior changes.

Other names: Med-South Program

Primary outcomes

  1. Percentage of Eligible Patients Participating

    Time frame: Month 10

    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.

  2. Percentage of Med-South Lifestyle Program Delivered as Intended

    Time frame: Month 10

    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.

Secondary outcomes

  1. Mean Change in Number of Fruit and Vegetable Servings Per Day

    Time frame: Month 0, Month 10

    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.

  2. Mean Change in Minutes of Physical Activity Per Week

    Time frame: Month 0, Month 10

    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.

  3. Mean Percent Change in Weight

    Time frame: Month 0, Month 10

    Mean weight change (in kg) from baseline to follow-up expressed as a percentage of baseline weight

  4. Mean Change in Systolic Blood Pressure at end of 4-Month Med-South Program

    Time frame: Month 0, Month 4

    Mean difference in systolic blood pressure measured at session 1 and at the end of the Med-south Program (session 4).

  5. Mean Change in Systolic Blood Pressure at end of 6-Month Maintenance Phase

    Time frame: Month 4, Month 10

    Mean difference in systolic blood pressure measured at session 4 of the Med-South Program and at the end of the maintenance phase (month 10).

  6. Mean Change in Diastolic Blood Pressure at end of 4-Month Med-South Program

    Time frame: Month 0, Month 4

    Mean difference in diastolic blood pressure measured at session 1 and at the end of the Med-South Program (session 4).

  7. Mean Change in Diastolic Blood Pressure at end of 6-Month Maintenance Phase

    Time frame: Month 4, Month 10

    Mean difference in diastolic blood pressure measured at session 4 of the Med-South Program and at the end of the maintenance phase (month 10).

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

Scaling up the Med-South Lifestyle Program to Reduce Chronic Disease in Partnership With Rural Communities: Phase 2

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Oct 5, 2021
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.