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

Completed

• Conditions: Coronary Heart Disease

• Registration Number: NCT03292055
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-13
• Study First Submitted: 2017-09-19
• Study First Submitted QC: 2017-09-22
• Study First Posted: 2017-09-25
• Primary Completion: 2017-12-15
• Study Completion: 2017-12-15
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-23
• Last Update Posted: 2018-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 235

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intake of Food	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	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	January-February, April- May, July- August, October- November	Participant's height will be measured to the nearest 0.5 cm, with a right-angle triangle resting on the scalp and against the wall, having the back square against the wall tape and eyes looking straight ahead. The height will be measured without wearing shoes.
BMI	January-February, April- May, July- August, October- November	weight and height will be combined to report BMI in kg/m\^2
Weight	January-February, April- May, July- August, October- November	A calibrated scale with the resolution of 0.1 kg will be used to measure the weight of the participants, who will be asked to wear light clothes during measurement. The weight will be measured without shoes.
Waist circumstance	January-February, April- May, July- August, October- November	Waist circumstance will be taken at the midpoint between the top of the iliac crest and the lower margin of the palpable rib
Blood pressure	January-February, April- May, July- August, October- November	To take the blood pressure, the participant will be asked to be seated for at least 15 minutes with his/her legs uncrossed (WHO, 2008). Two BP measurements will be taken and between the two readings, the participant will have three minutes' rest.

Secondary Outcome Measures

Name	Time	Method
Sociodemographic information	January-February	Age, gender, marital status, occupation, educational level, living conditions, financial background, and living areas will be collected using a self-developed questionnaire.
General clinical information	January-February	Smoking history, family history and clinical data will be collected using a self-developed questionnaire.
Clinical Information	October- November	Their clinical information on hospital readmission, surgery or medical procedures, and medication adjustment during the last year will be collected.
Physical activity level	January-February, April- May, July- August, October- November	The physical activity level of the participants will be measured using the Chinese version of the short version of International Physical Activity Questionnaire (short- Chinese IPAQ).

Trial Locations

Locations (2)

Qilu Hospital; 🇨🇳 Jinan, Shandong, China

Jinan Central Hospital; 🇨🇳 Jinan, Shandong, China