Validation of a Food Frequency Questionnaire

April 3, 2020 updated by: Danone Asia Pacific Holdings Pte, Ltd.

Validation of Dietary Patterns and Inflammatory Salivary Biomarkers Among Healthy Toddlers of 15-36 Months Old in Singapore

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

95

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 3 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

children who are aged 15-36 months and of Chinese, Indian or Malay ethnicity

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Salivary Inflammatory Biomarkers
Time Frame: up to 1 month
C-reactive protein, salivary IgA, alpha amylase
up to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danone Asia Pacific Holdings Pte, Ltd.

Investigators

  • Principal Investigator: Elena Sandalova, PhD, Danone Nutricia Early Life Nutrition
  • Study Chair: Smita Nambiar-Mann, PhD, Danone Nutricia Early Life Nutrition

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

December 31, 2016

Study Registration Dates

First Submitted

February 13, 2017

First Submitted That Met QC Criteria

May 1, 2017

First Posted (Actual)

May 3, 2017

Study Record Updates

Last Update Posted (Actual)

April 14, 2020

Last Update Submitted That Met QC Criteria

April 3, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • SGP. 1.A/A/3, PIEC2015/023.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

the whole data set (without traceability to the participant) may be available for other researchers for secondary analyses

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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