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

Coronary Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03292055
• Other study ID #: 2016.557
• Status: Completed
• Phase: N/A
• First received: September 19, 2017
• Last updated: January 23, 2018
• Start date: January 13, 2017
• Est. completion date: December 15, 2017

Study information

• Verified date: January 2018
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 235
• Est. completion date: December 15, 2017
• Est. primary completion date: December 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Locations

Country	Name	City	State
China	Jinan Central Hospital	Jinan	Shandong
China	Qilu Hospital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intake of Food	The newly developed FFQ (CHD-FFQ) will be applied to the participants to collect their dietary intake of food.	January-February, April- May, July- August, October- November
Primary	Cardiac-related physiological blood parameters	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.	January- February, October- November
Primary	Height	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.	January-February, April- May, July- August, October- November
Primary	Weight	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.	January-February, April- May, July- August, October- November
Primary	BMI	weight and height will be combined to report BMI in kg/m^2	January-February, April- May, July- August, October- November
Primary	Waist circumstance	Waist circumstance will be taken at the midpoint between the top of the iliac crest and the lower margin of the palpable rib	January-February, April- May, July- August, October- November
Primary	Blood pressure	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.	January-February, April- May, July- August, October- November
Primary	Intake of Food	As a criterion, the FFQ developed by Chinese CDC will be applied to the participants to collect their dietary intake of food.	October-November
Secondary	Sociodemographic information	Age, gender, marital status, occupation, educational level, living conditions, financial background, and living areas will be collected using a self-developed questionnaire.	January-February
Secondary	General clinical information	Smoking history, family history and clinical data will be collected using a self-developed questionnaire.	January-February
Secondary	Clinical Information	Their clinical information on hospital readmission, surgery or medical procedures, and medication adjustment during the last year will be collected.	October- November
Secondary	Physical activity level	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).	January-February, April- May, July- August, October- November