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.
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.
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.
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)
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.
- First posted6 Nov 2018
- Study start29 Nov 2018
- Primary completion6 Nov 2019
- Study completion14 Nov 2019
Why it stopped: Unable to recruit enough participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary IntakeStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruth Chan, Chinese University of Hong Kong
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproducibility and Relative Validity of a Semi-quantitative Food Frequency Questionnaire for Chinese Pregnant Women in Hong Kong
- ClinicalTrials.gov ID
- NCT03732196
- Acronym / sponsor ID
- 2018.440
- Conditions
- Dietary Intake
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Unable to recruit enough participants
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 29 Nov 2018 (actual)
- Primary completion
- 6 Nov 2019 (actual)
- Study completion
- 14 Nov 2019 (actual)
- First posted
- 6 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference in dietary intakes
Time frame: Baseline
Difference in dietary intakes measured using Food Frequency Questionnaire and multiple 24-hour recalls will be examined
1 secondary outcome
Change in dietary intakes
Time frame: Change betwen baseline and one month
Results and safety
The study was stopped early (reason given: Unable to recruit enough participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.