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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 1
- 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:
- Risk factors for CVD, including LDL cholesterol and blood pressure; and
- 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
- 是
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
研究组 & 干预措施
Vegan Diet
Participants in this group will follow a plant-based vegan diet. The vegan group diet will be based on investigators' pilot work, which instructs participants to favor a diet built around whole grains, fruits, vegetables, and legumes. This group will be supplemented by the Oldways African Heritage and Health program, which includes a food pyramid guide. A Taste of African Heritage (ATAH) six-lesson nutrition and cooking program and an online course for health professionals and cooking instructors (all research and restaurant team members will complete this course.
Interventions include intervention meetings, physical activity, and podcasts/mailings.
干预措施: Dietary Intervention Meetings (Behavioral)
Vegan Diet
Participants in this group will follow a plant-based vegan diet. The vegan group diet will be based on investigators' pilot work, which instructs participants to favor a diet built around whole grains, fruits, vegetables, and legumes. This group will be supplemented by the Oldways African Heritage and Health program, which includes a food pyramid guide. A Taste of African Heritage (ATAH) six-lesson nutrition and cooking program and an online course for health professionals and cooking instructors (all research and restaurant team members will complete this course.
Interventions include intervention meetings, physical activity, and podcasts/mailings.
干预措施: Physical Activity (Behavioral)
Vegan Diet
Participants in this group will follow a plant-based vegan diet. The vegan group diet will be based on investigators' pilot work, which instructs participants to favor a diet built around whole grains, fruits, vegetables, and legumes. This group will be supplemented by the Oldways African Heritage and Health program, which includes a food pyramid guide. A Taste of African Heritage (ATAH) six-lesson nutrition and cooking program and an online course for health professionals and cooking instructors (all research and restaurant team members will complete this course.
Interventions include intervention meetings, physical activity, and podcasts/mailings.
干预措施: Podcasts/Mailings (Behavioral)
Omnivorous (Omni) Diet
Participants in this group will follow a low-fat omni diet. The diet intervention for the omni group will be supplemented by the Oldways African Heritage and Health program, which includes a food pyramid guide, A Taste of African Heritage (ATAH) six-lesson nutrition and cooking program and an online course for health professionals and cooking instructors (all research and restaurant team members will complete this course).
Interventions include intervention meetings, physical activity, and podcasts/mailings.
干预措施: Dietary Intervention Meetings (Behavioral)
Omnivorous (Omni) Diet
Participants in this group will follow a low-fat omni diet. The diet intervention for the omni group will be supplemented by the Oldways African Heritage and Health program, which includes a food pyramid guide, A Taste of African Heritage (ATAH) six-lesson nutrition and cooking program and an online course for health professionals and cooking instructors (all research and restaurant team members will complete this course).
Interventions include intervention meetings, physical activity, and podcasts/mailings.
干预措施: Physical Activity (Behavioral)
Omnivorous (Omni) Diet
Participants in this group will follow a low-fat omni diet. The diet intervention for the omni group will be supplemented by the Oldways African Heritage and Health program, which includes a food pyramid guide, A Taste of African Heritage (ATAH) six-lesson nutrition and cooking program and an online course for health professionals and cooking instructors (all research and restaurant team members will complete this course).
Interventions include intervention meetings, physical activity, and podcasts/mailings.
干预措施: Podcasts/Mailings (Behavioral)
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
Brie Turner-McGrievy
Associate Professor
University of South Carolina