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Validation of a Food Frequency Questionnaire

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ClinicalTrials.gov Identifier: NCT03138330
Recruitment Status : Completed
First Posted : May 3, 2017
Results First Posted : April 2, 2020
Last Update Posted : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
Danone Asia Pacific Holdings Pte, Ltd.

Tracking Information
First Submitted Date February 13, 2017
First Posted Date May 3, 2017
Results First Submitted Date March 5, 2020
Results First Posted Date April 2, 2020
Last Update Posted Date April 14, 2020
Actual Study Start Date December 2015
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 3, 2020)
Validated Food Frequency Questionnaire [ Time Frame: up to 1 month ]
Ninety-one parents completed the sqFFQ and a 2-day weighed food record as the reference method. Intake of energy and nutrients (energy, carbohydrates, fat, protein, fibre, sugars, calcium and iron) were determined for each method and compared using Pearson correlations.
Original Primary Outcome Measures
 (submitted: May 1, 2017)
Validated Food Frequency Questionnaire [ Time Frame: 1 year ]
Food Frequency Questionnaire will be validated for a range of macronutrients and micronutrients: energy, carbohydrates, fat, protein, fibre, sugars, calcium and iron.
Change History
Current Secondary Outcome Measures
 (submitted: April 3, 2020)
Salivary Inflammatory Biomarkers [ Time Frame: up to 1 month ]
C-reactive protein, salivary IgA, alpha amylase
Original Secondary Outcome Measures
 (submitted: May 1, 2017)
  • Salivary Inflammatory Biomarkers [ Time Frame: 1 year ]
    C-reactive protein, salivary IgA, alpha amylase
  • Parental feeding practices/behaviour [ Time Frame: 1 year ]
    28 questions measuring reward for behaviour, reward for eating, persuasive feeding, covert restriction, structured meal setting, structured meal timing
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Validation of a Food Frequency Questionnaire
Official Title Validation of Dietary Patterns and Inflammatory Salivary Biomarkers Among Healthy Toddlers of 15-36 Months Old in Singapore
Brief Summary The purpose of this study is to collect nutritional information from young children aged 15-36 months to validate a newly developed food frequency questionnaire.
Detailed Description

The primary purpose of this study is to validate a semi-quantitative food frequency questionnaire (FFQ) against a reference method (2-day weighed food records) in a sample of young children aged 15-36 months.

In addition to dietary data, the investigators also collected information on parental demographics, toddler health with regards to allergies and intolerance, parental feeding practices, parent and child weight and height and lastly, saliva samples to study inflammatory markers.

Therefore, in addition to the validation of the FFQ- the data will also be used to study associations between dietary patterns, food and nutrient intake and (i) parental feeding practices and (ii) inflammatory biomarkers from saliva

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
saliva
Sampling Method Non-Probability Sample
Study Population children who are aged 15-36 months and of Chinese, Indian or Malay ethnicity
Condition Nutrition
Intervention Other: this study is observational, it is not an intervention
Study Groups/Cohorts Not Provided
Publications * Allan C, Abdul Kader UH, Ang JYY, Muhardi L, Nambiar S. Relative validity of a semi-quantitative food frequency questionnaire for Singaporean toddlers aged 15-36 months. BMC Nutr. 2018 Dec 11;4:42. doi: 10.1186/s40795-018-0252-9. eCollection 2018.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 1, 2017)
95
Original Actual Enrollment Same as current
Actual Study Completion Date December 31, 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. 15-36 months old boys and girls who are healthy
  2. Toddlers who are from either Chinese, Malay or Indian ethnic group

Exclusion Criteria:

  1. Toddlers with any acute or chronic illness, such as chronic inflammatory bowel disease, or illness that negatively affects food intake (e.g. Crohn's disease or ulcerative colitis).
  2. Toddlers with history of antibiotics used in the last 1 week before the study.
  3. Toddlers with history of vaccination in the last 2 weeks before the study
  4. Toddlers with one or both parents of Caucasian origin.
Sex/Gender
Sexes Eligible for Study: All
Ages 15 Months to 36 Months   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03138330
Other Study ID Numbers SGP. 1.A/A/3, PIEC2015/023.
Has Data Monitoring Committee Yes
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
Plan to Share IPD: Undecided
Plan Description: the whole data set (without traceability to the participant) may be available for other researchers for secondary analyses
Responsible Party Danone Asia Pacific Holdings Pte, Ltd.
Study Sponsor Danone Asia Pacific Holdings Pte, Ltd.
Collaborators Not Provided
Investigators
Principal Investigator: Elena Sandalova, PhD Danone Nutricia Early Life Nutrition
Study Chair: Smita Nambiar-Mann, PhD Danone Nutricia Early Life Nutrition
PRS Account Danone Asia Pacific Holdings Pte, Ltd.
Verification Date April 2020