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Food Frequency Questionnaire (FFQ) for Coronary Heart Disease (CHD) Patients

The Chinese University of Hong Kong logo

The Chinese University of Hong Kong

Status

Completed

Conditions

Coronary Heart Disease

Study type

Observational

Funder types

Other

Identifiers

NCT03292055
2016.557

Details and patient eligibility

About

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.

Enrollment

235 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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