Clinical trial NCT03292055: Food Frequency Questionnaire (FFQ) for Coronary Heart Disease (CHD) Patients
Official title: Evaluation of the Psychometric Properties of a Food Frequency Questionnaire Developed for Patients With Coronary Heart Disease in Northern China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Heart Disease
Keywords: food frequency questionnaire; psychometric properties
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: CHD high-risk patients (corresponding to the inclusion criteria)

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Intake of Food
timeFrame: January-February, April- May, July- August, October- November
measure: Cardiac-related physiological blood parameters
timeFrame: January- February, October- November
measure: Height
timeFrame: January-February, April- May, July- August, October- November
measure: Weight
timeFrame: January-February, April- May, July- August, October- November
measure: BMI
timeFrame: January-February, April- May, July- August, October- November
measure: Waist circumstance
timeFrame: January-February, April- May, July- August, October- November
measure: Blood pressure
timeFrame: January-February, April- May, July- August, October- November
measure: Intake of Food
timeFrame: October-November
Secondary outcomes:
measure: Sociodemographic information
timeFrame: January-February
measure: General clinical information
timeFrame: January-February
measure: Clinical Information
timeFrame: October- November
measure: Physical activity level
timeFrame: January-February, April- May, July- August, October- November
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital
state: Shandong
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
Study officials:
affiliation: Chinese University of Hong Kong
name: SekYing CHAIR, PHD
role: STUDY_DIRECTOR
References: