Med-South Lifestyle Study: Phase 1

Not Applicable

Completed

• Conditions: Healthy Lifestyle
• Interventions: Behavioral: Med-South Lifestyle Program

• Registration Number: NCT04421703
• 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 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 Timeline

• Study First Submitted: 2020-05-07
• Study First Submitted QC: 2020-06-04
• Study First Posted: 2020-06-09
• Study Start: 2020-12-01
• Primary Completion: 2021-12-15
• Study Completion: 2021-12-15
• Status Verified: 2023-07
• Last Update Submitted: 2023-11-06
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blended in-person/distance collaborative	Med-South Lifestyle Program	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.
Distance Collaborative	Med-South Lifestyle Program	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Eligible Patients Participating	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.
Percentage of Med-South Lifestyle Program Delivered as Intended	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.

Secondary Outcome Measures

Name	Time	Method
Mean Change in Minutes of Physical Activity Per Week	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.
Mean Change Number of Fruit and Vegetable Servings Per Day	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.
Mean Percent Change in Weight	Baseline, Month 6	Mean weight change (in kg) from baseline to follow-up expressed as a percentage.

Trial Locations

Locations (3)

Rural Health Group; 🇺🇸 Norlina, North Carolina, United States

Person Family Medical Center; 🇺🇸 Roxboro, North Carolina, United States

Granville-Vance Public Health; 🇺🇸 Oxford, North Carolina, United States