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临床试验/NCT03354377
NCT03354377已完成不适用

A Nutrition-Based Approach to Reduce Heart Disease Risk Among Overweight African Americans: Use of Soul Food Plant-Based or Omnivorous Diets to Address Cardiovascular Disease

University of South Carolina2 个研究点 分布在 1 个国家目标入组 159 人开始时间: 2018年5月7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
159
试验地点
2
主要终点
Cardiovascular Disease Prevention based on dietary approach.

研究概览

简要总结

This study addresses two challenges seen among African American (AA) participants during previous weight loss and dietary interventions aimed at reducing cardiovascular disease (CVD) risk: poor weight loss results and high attrition rates. Investigators will target both of these challenges by using a randomized design to compare a plant-based dietary intervention (vegan diet) vs. an omnivorous (omni) diet and by focusing on culturally-tailored food choices for AA adults living in the South. Therefore, the objective of the study is to conduct a culturally-tailored, randomized trial examining how a vegan diet affects CVD risk factors and weight as compared with an omni diet. The study will randomize overweight AA adults (n=130) to follow one of two different diets (vegan or omni) for 24 months. Investigators will accomplish objectives and test hypotheses by following two specific primary aims:

Primary Aims: Using a randomized design, determine the impact at 12 months of two different, culturally tailored diets (n=65 omni and n=65 vegan) on changes in:

  1. Risk factors for CVD, including LDL cholesterol and blood pressure; and
  2. Body weight.

Secondary Aim 3. Examine long-term changes in CVD risk factors and body weight at 24 months.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Self-identify as African American
  • Be between the ages of 18-65 years
  • Body Mass Index between 25- 49.9 kg/m2
  • Live in the Columbia, SC/Midlands area
  • Be able to attend all monitoring and weekly class visits
  • Be willing to be randomized to either diet

排除标准

  • Currently following a vegan diet
  • Diagnosed with diabetes that is controlled by medication
  • Currently pregnant or breastfeeding (or plan to become pregnant in the next 24 months)
  • Under the age of 18 years old
  • Over the age of 65 years old
  • Currently participating in a weight loss program
  • Has lost more than 10 pounds in the past 6 months
  • Diagnosed with stroke or heart attack

结局指标

主要结局

Cardiovascular Disease Prevention based on dietary approach.

时间窗: Two years

Which dietary approach (vegan or omni) best targets both cardiovascular disease prevention and weight loss among overweight African Americans.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Brie Turner-McGrievy

Associate Professor

University of South Carolina

研究点 (2)

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