NEW Soul D&I: Expanding the Reach of the Nutritious Eating With Soul (NEW Soul) Program
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Changes in body weight
研究概览
简要总结
The investigators will conduct a full dissemination and implementation study using a type 2 hybrid effectiveness-implementation design. The investigators will conduct this study in the community and work with two vegan soul food restaurants. The investigators propose to examine the effectiveness and implementation of community-delivered, 3-month NEW Soul program among participants (N=228).
Using a randomized design, the investigators will assess effectiveness of two delivery approaches: (1) In-person, live weekly classes with restaurant vouchers (intervention) or (2) restaurant voucher-only (active control).
The investigators will also conduct a cost-effectiveness analysis of delivering the online intervention plus voucher vs. voucher-only with the outcome of cost/change in weight, healthy eating index, and quality adjusted life year.
Lastly, the investigators will examine the implementation of the NEW Soul study with participants and intervention staff.
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
- •Able to travel to restaurant for classes
- •Be able to attend all monitoring and weekly class visits
- •Be willing to be randomized to either group
排除标准
- •Currently following a plant-based 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
- •Potential eating disorder
研究组 & 干预措施
Intervention
The intervention condition participants will be instructed to follow a plant-based diet. The intervention participants will receive weekly group classes for 3 months at a local restaurant and will receive guidance on how to choose foods to meet their nutrient needs that fit within the vegan diet. The intervention participants will receive a voucher each week for a free plant-based meal at the restaurant.
干预措施: Plant-based diet (Behavioral)
Control
Participants in the active control condition will receive meal vouchers to the restaurant. The active control condition participants will not receive any instruction to follow a particular diet or support. Participants in this condition will receive all intervention material and attend a class at the end of the study to learn about the intervention diet.
干预措施: Voucher only (Other)
结局指标
主要结局
Changes in body weight
时间窗: 3-months
Changes in body weight in kilograms
Changes in diet quality
时间窗: 3-months
Changes in dietary quality as assessed by the Healthy Eating Index
次要结局
- Implementation(3-months)
- Cost-effectiveness(3-months)
研究者
Brie Turner-McGrievy
Associate Professor
University of South Carolina