Food Frequency Questionnaire for Chinese Pregnant Women

Dietary Intake Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03732196
• Other study ID #: 2018.440
• Status: Terminated
• Start date: November 29, 2018
• Est. completion date: November 14, 2019

Study information

• Verified date: June 2020
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 68
• Est. completion date: November 14, 2019
• Est. primary completion date: November 6, 2019
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Dietary Intake

Locations

Country	Name	City	State
China	The Hong Kong Polytechnic University	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in dietary intakes	Difference in dietary intakes measured using Food Frequency Questionnaire and multiple 24-hour recalls will be examined	Baseline
Secondary	Change in dietary intakes	Change in dietary intakes measured using Food Frequency Questionnaire at baseline and one month will be examined	Change betwen baseline and one month