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

NCT03292055 | Completed DMC

• 1 other identifier: 2016.557
• Study Type: observational
• Target: 235
• Locations: 1 country
• Sites: 2

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.

Conditions

Coronary Heart Disease

Keywords

food frequency questionnaire; psychometric properties

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• BMI

  weight and height will be combined to report BMI in kg/m\^2

  January-February, April- May, July- August, October- November

• 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

• 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

• 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 Outcomes (4)

• Sociodemographic information

  January-February

• General clinical information

  January-February

• Clinical Information

  October- November

• Physical activity level

  January-February, April- May, July- August, October- November

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

CHD high-risk patients (corresponding to the inclusion criteria)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (2)

Qilu Hospital

Jinan, Shandong, 250012, China

Location

Jinan Central Hospital

Jinan, Shandong, 250013, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood testing for the blood glucose, lipid profile

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• SekYing CHAIR, PHD

  Chinese University of Hong Kong

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Assistant

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: September 25, 2017
• Study Start: January 13, 2017
• Primary Completion: December 15, 2017
• Study Completion: December 15, 2017
• Last Updated: January 25, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)