Evaluation of the Psychometric Properties of a Food Frequency Questionnaire Developed for Patients With Coronary Heart Disease in Northern China

Chinese University of Hong Kong2 个研究点分布在 1 个国家目标入组 235 人开始时间: 2017年1月13日最近更新: 2018年1月25日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Chinese University of Hong Kong
入组人数: 235
试验地点: 2
主要终点: Intake of Food

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study aims to evaluate the psychometric properties of a newly developed FFQ specified for northern Chinese CHD and their high risk patients (CHD-FFQ). The psychometric properties include test-retest reliability, content validity, convergent validity, discriminant validity, concurrent validity and predictive validity. Particularly, this study will measure the physiological indicators, including plasma lipid profile (i.e. TG, TC, HDL-C, LDL-C), BG, BP and BMI twice at baseline and the end. The level of these physiological indicators will be compared with the fat intake measured by the CHD-FFQ, i.e. the baseline intake to test its convergent validity. It is also expected to predict the diet-related progression of CHD risks among high-risk individuals, i.e. patients with two or more CHD risk factors as following: raised fasting blood glucose (BG) level, increased blood pressure (BP), increased triglycerides (TG), decreased HDL-Cholesterol (HDL-C), increased LDL-Cholesterol (LDL-C), smoking and central obesity (International Diabetes Federation, 2015). In addition, this study will provide the FFQ's concurrent validity in assessing the intake of energy and nutrients against the CDC-FFQ. Moreover, whether the FFQ could detect the known differences in energy intake between men and women will be established for its discriminant validity.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

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

入选标准

•18 years or older;
•Have no CHD at enrollment;
•At high risk of CHD with at least two of the following risk factors:
•current smoking: current smokers are defined as individuals who smoked regularly during the last 12 months
•central obesity: for Chinese, central obesity is defined as waist circumstance above 90cm for male and 80cm for female, or with BMI above 30kg/m²
•raised BP (systolic BP [SBP] ≥ 130 mmHg or diastolic BP [DBP] ≥85 mmHg or under antihypertensive treatment)
•raised fasting BG (FBG) (100mg/dL [5.6mmol/L]) or under treatment with insulin or oral hypoglycemic agents
•elevated TG (150mg/dL [1.7mmol/L])
•elevated TC (≥ 240 mg/dL [5.18 mmol/L])
•raised LDL-C (≥ 160 mg/dL [4.15 mmol/L])
•decreased HDL-C (<40 mg/dL [1.03 mmol/L] for males, and <50 mg/dL [1.29 mmol/L] for females)
•undergoing hyperlipidemia treatment

排除标准

•Impaired bilateral hearing
•Impaired mental status (according to their medical record)

结局指标

主要结局

Intake of Food

时间窗: October-November

As a criterion, the FFQ developed by Chinese CDC will be applied to the participants to collect their dietary intake of food.

Cardiac-related physiological blood parameters

时间窗: January- February, October- November

In the beginning and the end of the study, the medical records of the participants will be refered to get the blood glucose, total cholesterol, triglycerides, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol in the past three months, in the department and the community centers.

Height