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临床试验/NCT05067816
NCT05067816已完成不适用

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

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 368 人开始时间: 2021年10月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
368
试验地点
2
主要终点
Percentage of Eligible Patients Participating

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female
  • English speaking (Spanish-speaking only in selected sites with bilingual staff)
  • Ages 18-80

排除标准

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

结局指标

主要结局

Percentage of Eligible Patients Participating

时间窗: 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

时间窗: 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.

次要结局

  • Mean Change in Number of Fruit and Vegetable Servings Per Day(Month 0, Month 10)
  • Mean Change in Minutes of Physical Activity Per Week(Month 0, Month 10)
  • Mean Percent Change in Weight(Month 0, Month 10)
  • Mean Change in Systolic Blood Pressure at end of 4-Month Med-South Program(Month 0, Month 4)
  • Mean Change in Systolic Blood Pressure at end of 6-Month Maintenance Phase(Month 4, Month 10)
  • Mean Change in Diastolic Blood Pressure at end of 4-Month Med-South Program(Month 0, Month 4)
  • Mean Change in Diastolic Blood Pressure at end of 6-Month Maintenance Phase(Month 4, Month 10)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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