Med-South Lifestyle Program Implementation Study
- Conditions
- Healthy Lifestyle
- Interventions
- Behavioral: Med-South Lifestyle Program
- Registration Number
- NCT05067816
- Lead Sponsor
- University of North Carolina, Chapel Hill
- Brief 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 368
- Male or female
- English speaking (Spanish-speaking only in selected sites with bilingual staff)
- Ages 18-80
- Malignancy
- Advanced kidney disease (estimated creatinine clearance < 30 mL/min)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Quality Improvement Collaborative Scale-Up Format Med-South Lifestyle Program 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. Distance Scale-Up Format Med-South Lifestyle Program 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.
- Primary Outcome Measures
Name Time Method Percentage of Eligible Patients Participating 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.
Percentage of Med-South Lifestyle Program Delivered as Intended 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 Outcome Measures
Name Time Method Mean Change in Number of Fruit and Vegetable Servings Per Day 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.Mean Change in Minutes of Physical Activity Per Week 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.
Mean Percent Change in Weight Month 0, Month 10 Mean weight change (in kg) from baseline to follow-up expressed as a percentage of baseline weight
Mean Change in Systolic Blood Pressure at end of 4-Month Med-South Program 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).
Mean Change in Systolic Blood Pressure at end of 6-Month Maintenance Phase 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).
Mean Change in Diastolic Blood Pressure at end of 4-Month Med-South Program 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).
Mean Change in Diastolic Blood Pressure at end of 6-Month Maintenance Phase 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).
Trial Locations
- Locations (1)
UNC Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States