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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.

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Cross-Sectional
Condition Nutrition
Intervention Other: this study is observational, it is not an intervention
Enrollment 95
Recruitment Details  
Pre-assignment Details  
Arm/Group Title FFQ Group
Hide Arm/Group Description Ninety-one parents of Singaporean toddlers completed the sqFFQ and a 2-day weighed food record as the reference method.
Period Title: Overall Study
Started 95
Completed 91
Not Completed 4
Arm/Group Title FFQ Group
Hide Arm/Group Description The study included toddlers of 15-39 months of age of Chinese, Malay, or Indian ethnicity in Singapore.
Overall Number of Baseline Participants 91
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants
<=18 years
91
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 91 participants
23  (7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants
Female
47
  51.6%
Male
44
  48.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Singapore Number Analyzed 91 participants
91
1.Primary Outcome
Title Validated Food Frequency Questionnaire
Hide Description 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.
Time Frame up to 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
Ninety-one parents of Singaporean toddlers who completed the sqFFQ and a 2-day weighed food record. Here pearson correlation between the two methods (FFQ and food diary) is presented.
Arm/Group Title FFQ Group
Hide Arm/Group Description:
The study included toddlers of 15-39 months of age of Chinese, Malay, or Indian ethnicity in Singapore.
Overall Number of Participants Analyzed 91
Measure Type: Number
Unit of Measure: Pearson correlation
total Energy 0.39
Protein 0.35
total fat 0.28
total carbohydrates 0.32
sugars 0.42
fibre 0.56
Calcium 0.62
Iron 0.28
2.Secondary Outcome
Title Salivary Inflammatory Biomarkers
Hide Description C-reactive protein, salivary IgA, alpha amylase
Time Frame up to 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had sufficient saliva sample for analysis. There was not sufficient saliva sample to measure the CRP values, thus CRP values are not reported.
Arm/Group Title FFQ Group
Hide Arm/Group Description:
The study included toddlers of 15-39 months of age of Chinese, Malay, or Indian ethnicity in Singapore.
Overall Number of Participants Analyzed 76
Mean (Standard Deviation)
Unit of Measure: ug/ml
IgA 119314  (157368)
Amylase 79  (60)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title FFQ Group
Hide Arm/Group Description The study included toddlers of 15-39 months of age of Chinese, Malay, or Indian ethnicity in Singapore.
All-Cause Mortality
FFQ Group
Affected / at Risk (%)
Total   0/91 (0.00%) 
Hide Serious Adverse Events
FFQ Group
Affected / at Risk (%)
Total   0/91 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
FFQ Group
Affected / at Risk (%)
Total   0/91 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Elena Sandalova
Organization: Danone Nutricia Research
Phone: 6568309433
EMail: elena.sandalova@danone.com
Layout table for additonal information
Responsible Party: Danone Asia Pacific Holdings Pte, Ltd.
ClinicalTrials.gov Identifier: NCT03138330    
Other Study ID Numbers: SGP. 1.A/A/3, PIEC2015/023.
First Submitted: February 13, 2017
First Posted: May 3, 2017
Results First Submitted: March 5, 2020
Results First Posted: April 2, 2020
Last Update Posted: April 14, 2020