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NCT Number: NCT03292055

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

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.

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Key information

Conditions

Coronary Heart Disease Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jinan Central Hospital, Jinan, Shandong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Intake of Food

    Time frame: January-February, April- May, July- August, October- November

    The newly developed FFQ (CHD-FFQ) will be applied to the participants to collect their dietary intake of food.

  2. Cardiac-related physiological blood parameters

    Time frame: 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.

  3. Height

    Time frame: 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.

  4. Weight

    Time frame: 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.

  5. BMI

    Time frame: January-February, April- May, July- August, October- November

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

  6. Waist circumstance

    Time frame: 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

  7. Blood pressure

    Time frame: 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.

  8. Intake of Food

    Time frame: October-November

    As a criterion, the FFQ developed by Chinese CDC will be applied to the participants to collect their dietary intake of food.

Secondary outcomes

  1. Sociodemographic information

    Time frame: January-February

    Age, gender, marital status, occupation, educational level, living conditions, financial background, and living areas will be collected using a self-developed questionnaire.

  2. General clinical information

    Time frame: January-February

    Smoking history, family history and clinical data will be collected using a self-developed questionnaire.

  3. Clinical Information

    Time frame: October- November

    Their clinical information on hospital readmission, surgery or medical procedures, and medication adjustment during the last year will be collected.

  4. Physical activity level

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 25, 2017
Registry last updated
Jan 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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