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Food Frequency Questionnaire for Chinese Pregnant Women

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ClinicalTrials.gov Identifier: NCT03732196
Recruitment Status : Terminated (Unable to recruit enough participants)
First Posted : November 6, 2018
Last Update Posted : June 22, 2020
Sponsor:
Information provided by (Responsible Party):
Ruth Chan, Chinese University of Hong Kong

Tracking Information
First Submitted Date November 1, 2018
First Posted Date November 6, 2018
Last Update Posted Date June 22, 2020
Actual Study Start Date November 29, 2018
Actual Primary Completion Date November 6, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 5, 2018)
Difference in dietary intakes [ Time Frame: Baseline ]
Difference in dietary intakes measured using Food Frequency Questionnaire and multiple 24-hour recalls will be examined
Original Primary Outcome Measures
 (submitted: November 4, 2018)
Daily intake of various food groups and nutrients from diet by the food frequency questionnaire [ Time Frame: Change between baseline and one month ]
Daily intake of various food groups and nutrients from diet by the food frequency questionnaire
Change History
Current Secondary Outcome Measures
 (submitted: November 5, 2018)
Change in dietary intakes [ Time Frame: Change betwen baseline and one month ]
Change in dietary intakes measured using Food Frequency Questionnaire at baseline and one month will be examined
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Food Frequency Questionnaire for Chinese Pregnant Women
Official Title Reproducibility and Relative Validity of a Semi-quantitative Food Frequency Questionnaire for Chinese Pregnant Women in Hong Kong
Brief 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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
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.
Condition Dietary Intake
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: June 18, 2020)
68
Original Estimated Enrollment
 (submitted: November 4, 2018)
100
Actual Study Completion Date November 14, 2019
Actual Primary Completion Date November 6, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03732196
Other Study ID Numbers 2018.440
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Ruth Chan, Chinese University of Hong Kong
Study Sponsor Chinese University of Hong Kong
Collaborators Not Provided
Investigators Not Provided
PRS Account Chinese University of Hong Kong
Verification Date June 2020