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Dietary IntakeNCT03732196

Food Frequency Questionnaire for Chinese Pregnant Women

An observational study of Dietary Intake, run by Chinese University of Hong Kong at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The present study aims to evaluate the reproducibility and relative validity of a semi-quantitative food frequency questionnaire (FFQ) to assess food group consumption and nutrient intake for Chinese pregnant women in Hong Kong. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Dietary Intake
How many people
68 participants
Where
1 siteChina
Study dates
29 Nov 2018to 14 Nov 2019
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
  • Women only
  • Adult, Older adult

Study population: A total of 100 apparently healthy pregnant women aged 18 or above and with gestational age of at least 5 weeks willl be recruited from the antenatal clinic of the Prince of Wales Hospital. The research staff will check for eligible subjects, explain study details and invite them to join the study. Written consent will be obtained from all subjects. Various maternal data will be collected using standardized methods and questionnaires, and retrieved from the hospital record.

Who may be able to join

  • Should be Hong Kong Chinese citizen
  • Should reside normally in Hong Kong
  • Age at or above 18 years old
  • With antenatal registry in the study hospital
  • Singleton pregnancy
  • Gestational age of 5 weeks or above
  • Could speak and understand Chinese
  • Willing to follow the study procedures

Who cannot join

  • Currently participating in any clinical trial or trial with dietary intervention
  • Multiple pregnancy
  • With any renal, liver or thyroid dysfunction, any other indication of a major medical or psychological illness, as judged by the investigators as ineligible to participate the study

Trial locations and contacts

1 site in 1 country.

China1 site
  • The Hong Kong Polytechnic University

    Hong Kong

Other trials in China

About this study

Official title: Reproducibility and Relative Validity of a Semi-quantitative Food Frequency Questionnaire for Chinese Pregnant Women in Hong Kong

The present study aims to evaluate the reproducibility and relative validity of a semi-quantitative food frequency questionnaire (FFQ) to assess food group consumption and nutrient intake for Chinese pregnant women in Hong Kong.

A total of 100 apparently healthy pregnant women aged 18 or above and with gestational age of at least 5 weeks willl be recruited from the antenatal clinic of the Prince of Wales Hospital. The research staff will check for eligible subjects, explain study details and invite them to join the study. Written consent will be obtained from all subjects. Various maternal data will be collected using standardized methods and questionnaires, and retrieved from the hospital record.

Each participant will be asked to complete the FFQ twice within 3 to 4 weeks interval (for reproducibility evaluation), and three 24-hour food recalls in between the two administrations of the FFQ as a reference method to validate the FFQ (for validity evaluation). The three 24-hour food recalls will include two weekdays and one weekend day. On the interview day in which the 1st FFQ is administrated (FFQ1), each participant will be explained by trained research staff on how to complete the FFQ by herself with the provision of the food portion booklet. Each participant will be asked to complete the 1st FFQ regarding her intake of various food groups over the past month. The frequency of food group intake will be reported per day, week or month, and portions will be reported based on standard referent portion sizes, as pieces, glasses, cups, spoons, centilitres or grams. Data on use of supplements will be collected by asking subjects to specify the brand, the frequency, and the dosage of supplements used. On the same interview day, participant will also be asked by trained research staff to recall all foods and beverages that have been consumed over the past 24 hours. Food photo albums and eating utensils of standardized portions will be displayed to help recall. The 2nd administration of the FFQ (FFQ2) will be done 3 to 4 weeks after the 1st administration of the FFQ. The FFQ2 and the food portion booklet as well as the additional 24-hour recall forms will be given to the participants by email or post within 3 to 4 weeks after the 1st administration of the FFQ (FFQ1). Between the intervals of two FFQs, the research staff will give phone call to the participant on two separate days to complete two more 24-hour food recalls for validity evaluation purpose. Daily dietary and nutrient intake collected by both FFQs and 24-hour recalls will be entered and calculated using the nutrition analysis software Food Processor Nutrition analysis and Fitness software version 8.0 (ESHA Research, Salem, USA) including local foods selected from food composition tables from China and Hong Kong.

Conditions
Dietary Intake

What is being measured

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

  1. Difference in dietary intakes

    Difference in dietary intakes measured using Food Frequency Questionnaire and multiple 24-hour recalls will be examined

    Measured: Baseline

Secondary outcomes (1)
  1. Change in dietary intakes

    Change in dietary intakes measured using Food Frequency Questionnaire at baseline and one month will be examined

    Measured: Change betwen baseline and one month

Timeline

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

  1. First posted6 Nov 2018
  2. Study start29 Nov 2018
  3. Primary completion6 Nov 2019
  4. Study completion14 Nov 2019

Why it stopped: Unable to recruit enough participants

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
Cross-sectional
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03732196
Sponsor's protocol ID
2018.440
Status last verified
Jun 2020
First submitted
1 Nov 2018
Last updated
22 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Dietary Intake, run by Chinese University of Hong Kong at 1 site 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 8 inclusion and 3 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: stopped early, as of the sponsor's last update on 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 was stopped early (reason given: Unable to recruit enough participants). Results are not available in the source record.

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?

Difference in dietary intakes (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 22 Jun 2020.

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