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Coronary Heart DiseaseNCT03292055

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

An observational study of Coronary Heart Disease, run by Chinese University of Hong Kong at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Heart Disease
How many people
235 participants
Where
2 sitesChina
Study dates
13 Jan 2017to 15 Dec 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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)
Show all 12Show fewer
  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Qilu Hospital

    Jinan, Shandong, 250012

  • Jinan Central Hospital

    Jinan, Shandong, 250013

Other trials in China

About this study

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

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.

Keywords
food frequency questionnaire; psychometric properties
Medical subject headings
Coronary Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intake of Food

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

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

  2. 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.

    Measured: January- February, October- November

  3. 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.

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

  4. 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.

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

  5. BMI

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

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

  6. 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

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

  7. 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.

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

  8. 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.

    Measured: October-November

Secondary outcomes (4)

  1. Sociodemographic information

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

    Measured: January-February

  2. General clinical information

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

    Measured: January-February

  3. Clinical Information

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

    Measured: October- November

  4. 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).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2017
  2. Study start13 Jan 2017
  3. Primary completion15 Dec 2017
  4. Study completion15 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
235 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03292055
Sponsor's protocol ID
2016.557
Status last verified
Jan 2018
First submitted
19 Sep 2017
Last updated
25 Jan 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: All questionnaires and other collected data will be stored in a locked file cabinet, and no names or other personal data of participants will be used in publication. Only the PI and her supervisor will have access to these data.

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Heart Disease, run by Chinese University of Hong Kong at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intake of Food (time frame: January-February, April- May, July- August, October- November). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03292055.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2018.

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