Building on the Dietary Guidelines: 3 Dietary Pattern (DG3D) Study - Testing a Teaching Kitchens and Food is Medicine Approach for Type 2 Diabetes Prevention
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Changes in Healthy Eating Index Score
研究概览
简要总结
The goal of this pilot clinical trial is to examine how receipt of ingredients for a Mediterranean diet (with or without nutrition classes) impacts Type 2 Diabetes Mellitus risk factors among adults in the US South. The main question it aims to answer is:
- Will greater improvements in diet quality (HEI Score) and body weight be seen in the group that receives grocery delivery and nutrition classes (TK+FiM) compared to the group receiving grocery delivery only (FiM only)?
Researchers will evaluate the changes in diet quality and body weight among participants in each group to see which group experiences greater improvements.
Participants will:
- be randomly assigned to either receive weekly grocery deliveries and attend weekly virtual nutrition classes for 4 weeks or receive weekly grocery deliveries only.
- be asked to complete surveys/questionnaires at the baseline and 4-week timepoints in the study.
- be asked to participate in a post-study focus group to talk about their experiences during the intervention.
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)
盲法说明
Assessors will be blinded to participant group.
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
- •18-65 years of age
- •BMI between 25- 49.9 kg/m2
- •Live in a southern state (as classified by the US Census)
- •Be able to complete all survey assessments via computer or phone
- •Have a wi-fi connection at home or other site to access Zoom-delivered interventions
- •Have three or more type 2 diabetes risk factors (NIDDK Risk factors for T2DM)
- •Own a digital body weight scale, have regular access, or be willing to purchase one
排除标准
- •Currently participating in a weight loss program or taking weight loss medications
- •Has lost more than 10 pounds in the past 6 months
- •Diagnosed with major health or psychiatric diseases, drug or alcohol dependency, thyroid conditions, diabetes, or pregnancy
- •Pregnant (or have been pregnant in the last 6 months), anticipating on becoming pregnant in the next 3 months, or currently breastfeeding
- •Diagnosed with an eating disorder as screened by the Eating disorder Screen for Primary care [ESP].
研究组 & 干预措施
FiM only
Active control receiving weekly grocery delivery with no virtual teaching kitchen (TK) Mediterranean diet intervention
干预措施: Food is Medicine Grocery Provision (FiM) (Behavioral)
FiM+TK
Virtual teaching kitchen (TK) Mediterranean diet intervention plus weekly grocery delivery
干预措施: Dietary Intervention Teaching Kitchen (TK) Classes (Behavioral)
FiM+TK
Virtual teaching kitchen (TK) Mediterranean diet intervention plus weekly grocery delivery
干预措施: Food is Medicine Grocery Provision (FiM) (Behavioral)
结局指标
主要结局
Changes in Healthy Eating Index Score
时间窗: 4 weeks
Changes in dietary quality as assessed by the Healthy Eating Index (HEI-2020; scale range 0-100 where a higher score means better dietary quality)
Changes in body weight
时间窗: 4 weeks
Changes in body weight
次要结局
未报告次要终点
研究者
Brie Turner-McGrievy
Professor
University of South Carolina