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临床试验/NCT05057650
NCT05057650已完成不适用

African American Health and Nutrition Intervention: Help Everyone Assess Risk Today: LEnten Nutrition Study (HEART-LENS) "Giving up Unhealthy Food for Lent"

Rush University Medical Center2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年3月3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
50
试验地点
2
主要终点
American College of Cardiology/American Heart Association (ACC/AHA) Atherosclerotic Cardiovascular Disease (ASCVD) Risk Calculator, ranging from 1% to 50% 10-year event risk

研究概览

简要总结

The purpose of this study is to evaluate the impact of community health screening, health education and nutritional intervention on risk factors for cardiovascular disease in a predominantly African American population. The health fair and intervention will take place in a church that typically improves their lifestyle by "giving up for Lent" certain foods or habits. Participation in this nutrition intervention is voluntary and each participant will sign an informed consent along with a waiver. On the waiver, the participant can agree to have all testing performed but can withdraw consent at any time or decide to have only some of the testing.

It was hypothesized that a community-based health screening and nutritional intervention will have a positive impact on the participants by:

  1. Measuring baseline risk factors
  2. Educating them about their individual risk for heart disease
  3. Providing education on healthy lifestyle
  4. Providing a nutritional intervention for 40 days with home- delivered plant-based meals nutrition that has been shown to lower cardiac risk factors
  5. Repeating the risk factor assessment at the end of the intervention, to demonstrate the degree of, if any, reduction in cardiac risk as assessed by the American College of Cardiology/American Heart Association (ACC/AHA) Atherosclerotic Cardiovascular Disease (ASCVD) Risk Calculator
  6. Motivating at-risk subjects to seek continued appropriate medical care and to institute more permanent relevant lifestyle changes (e.g., diet, exercise, medication compliance).

详细描述

Design and Methods:

A prospective study design will be implemented. Approximately 50 participants are expected to volunteer for the intervention. The health screening will consist of measuring stations. After signing an informed consent and a waiver, the participant will complete an intake form, which includes basic patient information and demographics including date of birth, gender, height, and race/ethnicity. Also on the intake form, the participant will list medications currently being taken, risk factors for heart disease (i.e., diabetes, hypertension, hyperlipidemia, and smoking), family history of heart disease, and current medical conditions. After completing the intake form, the participant will have their height, weight, blood pressure, and pulse measured. If the participant uses oxygen regularly or is feeling short of breath, oxygen saturation will be measured using a pulse oximeter. Finally, each participant will have a blood tests for fasting (preferably for 9 hours) blood glucose, hemoglobin A1C, insulin level, lipid profile, high-sensitivity C-reactive protein, small dense LDL cholesterol, lipoprotein a, trimethylamine N-oxide (TMAO) and suPAR at baseline. Each of these parameters will be repeated for comparison at day 40 of Lent (Easter weekend). Blood will be stored for future analysis, since assays for suPAR and TMAO may not be immediately available.

From the information gathered, each participant will be given a baseline American College of Cardiology/American Heart Association (ACC/AHA) Atherosclerotic Cardiovascular Disease (ASCVD) risk score, which is an estimate of the 10-year and lifetime risks of ASCVD (defined as coronary death or nonfatal myocardial infarction, or fatal or nonfatal stroke). After the last visit, health education and counseling will be provided which is tailored to each individual given the findings gathered during the initial screening and the change that occurred. The information gathered will be written down on a form for the participant to keep for his own records. Referrals to primary care physicians, cardiologists, or other healthcare providers will be given as needed after the initial or post-intervention risk assessment. Patients who undergo lipid, blood pressure or glucose lowering therapy between the two assessments will be censured from the appropriate laboratory data analysis.

Subject Selection:

Approximately 50 subjects will be enrolled.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Able to consent to dietary protocol
  • Willing to comply with study requirements and voluntarily agrees to participate in this clinical study after appropriate informed consent is provided.

排除标准

  • Vegetarians
  • Inability to regularly measure blood pressure if taking antihypertensive medications
  • Inability to regularly measure blood sugar if taking antihyperglycemic medications
  • Celiac disease (gluten enteropathy)
  • Treatment for eating disorder
  • Active treatment for malignancy
  • Inability to eat solid food
  • Fruit, nut or vegetable
  • Inclusion Criteria:
  • Able to consent to dietary protocol
  • Willing to comply with study requirements and voluntarily agrees to participate in this clinical study after appropriate informed consent is provided.
  • Exclusion Criteria:
  • Vegetarians
  • Inability to regularly measure blood pressure if taking antihypertensive medications
  • Inability to regularly measure blood sugar if taking antihyperglycemic medications
  • Celiac disease (gluten enteropathy)
  • Treatment for eating disorder
  • Active treatment for malignancy
  • Inability to eat solid food
  • Fruit, nut or vegetable allergy

结局指标

主要结局

American College of Cardiology/American Heart Association (ACC/AHA) Atherosclerotic Cardiovascular Disease (ASCVD) Risk Calculator, ranging from 1% to 50% 10-year event risk

时间窗: 5 weeks

ACC/AHA Guideline for Prevention Tool calculated based on blood pressure, total cholesterol, HDL cholesterol, diabetes, age, gender, ethnicity, and smoking history.

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

Kim Allan Williams

Chief, Cardiology Division, James B. Herrick Professor of Medicine

Rush University Medical Center

研究点 (2)

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