The Impact of a Fruit and Vegetable Provision Program on Cardiovascular Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Intake of fruits and vegetables measured by changes in Healthy Eating Index (HEI)
研究概览
简要总结
Participants in the intervention group of this study will receive weekly home deliveries of fruit & vegetables for 3 months. The primary objective of this study is to determine if increased access to fruits and vegetables leads to sustained dietary changes, measured through changes in the Healthy Eating Index (HEI). Secondary objectives are to determine whether increased fruit and vegetable access (increased HEI) ultimately leads to improved cardiovascular (CV) health indicators (e.g., body mass index, waist circumference, blood pressure, and levels of blood lipids and hemoglobin A1c).
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 19 years and older
- •Established patient at OHSU Center for Preventive Cardiology
- •Not requiring changes to medication regimen for the 6-month study duration
- •Must be eligible to register with produce delivery company (reside in Portland-metro area; have access to a computer with internet service; able to read English)
排除标准
- •Triglycerides > 500 mg/dL
- •Heavy alcohol use (> 3 drinks/day)
- •Uncontrolled hypertension (BP > 140/90)
- •LDL-C > 160 mg/dL
- •Uncontrolled diabetes mellitus (HbA1c > 8%)
- •Failure to provide informed consent
- •Current pregnancy
- •Healthy Eating Index (HEI) score of ≥ 80
结局指标
主要结局
Intake of fruits and vegetables measured by changes in Healthy Eating Index (HEI)
时间窗: 6 months
The HEI uses a scoring system to evaluate a set of foods. The scores range from 0 to 100. An ideal overall HEI score of 100 reflects that the set of foods aligns with key dietary recommendations from the Dietary Guidelines for Americans.
次要结局
- Changes in triglycerides(6 months)
- Changes in weight measured by body mass index(6 months)
- Changes in LDL-cholesterol(6 months)
- Changes in blood pressure(6 months)
- Changes in total cholesterol(6 months)
- Changes in HDL-cholesterol(6 months)
- Changes in waist circumference(6 months)
- Changes in blood glucose(6 months)
研究者
Tracy Severson
dietitian
Oregon Health and Science University