Trial Outcomes & Findings for Validation of a Food Frequency Questionnaire (NCT NCT03138330)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

95 participants

Primary outcome timeframe

up to 1 month

Results posted on

2020-04-14

Participant Flow

Participant milestones

Participant milestones
Measure	FFQ Group Ninety-one parents of Singaporean toddlers completed the sqFFQ and a 2-day weighed food record as the reference method.
Overall Study STARTED	95
Overall Study COMPLETED	91
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Validation of a Food Frequency Questionnaire

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FFQ Group n=91 Participants The study included toddlers of 15-39 months of age of Chinese, Malay, or Indian ethnicity in Singapore.
Age, Categorical <=18 years	91 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	23 months STANDARD_DEVIATION 7 • n=99 Participants
Sex: Female, Male Female	47 Participants n=99 Participants
Sex: Female, Male Male	44 Participants n=99 Participants
Region of Enrollment Singapore	91 participants n=99 Participants

PRIMARY outcome

Timeframe: up to 1 month

Population: 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.

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.

Outcome measures

Outcome measures
Measure	FFQ Group n=91 Participants The study included toddlers of 15-39 months of age of Chinese, Malay, or Indian ethnicity in Singapore.
Validated Food Frequency Questionnaire total Energy	0.39 Pearson correlation
Validated Food Frequency Questionnaire Protein	0.35 Pearson correlation
Validated Food Frequency Questionnaire total fat	0.28 Pearson correlation
Validated Food Frequency Questionnaire total carbohydrates	0.32 Pearson correlation
Validated Food Frequency Questionnaire sugars	0.42 Pearson correlation
Validated Food Frequency Questionnaire fibre	0.56 Pearson correlation
Validated Food Frequency Questionnaire Calcium	0.62 Pearson correlation
Validated Food Frequency Questionnaire Iron	0.28 Pearson correlation

SECONDARY outcome

Timeframe: up to 1 month

Population: 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.

C-reactive protein, salivary IgA, alpha amylase

Outcome measures

Outcome measures
Measure	FFQ Group n=76 Participants The study included toddlers of 15-39 months of age of Chinese, Malay, or Indian ethnicity in Singapore.
Salivary Inflammatory Biomarkers IgA	119314 ug/ml Standard Deviation 157368
Salivary Inflammatory Biomarkers Amylase	79 ug/ml Standard Deviation 60

Adverse Events

FFQ Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Elena Sandalova

Danone Nutricia Research

Phone: 6568309433

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place