NCT03138330

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 13, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 3, 2017

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

April 2, 2020

Completed
Last Updated

April 14, 2020

Status Verified

April 1, 2020

Enrollment Period

11 months

First QC Date

February 13, 2017

Results QC Date

March 5, 2020

Last Update Submit

April 3, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Validated Food Frequency Questionnaire

    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 Outcomes (1)

  • Salivary Inflammatory Biomarkers

    up to 1 month

Interventions

Eligibility Criteria

Age15 Months - 36 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • months old boys and girls who are healthy
  • Toddlers who are from either Chinese, Malay or Indian ethnic group

You may not qualify if:

  • 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).
  • Toddlers with history of antibiotics used in the last 1 week before the study.
  • Toddlers with history of vaccination in the last 2 weeks before the study
  • Toddlers with one or both parents of Caucasian origin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

saliva

Results Point of Contact

Title
Dr Elena Sandalova
Organization
Danone Nutricia Research

Study Officials

  • Elena Sandalova, PhD

    Danone Nutricia Early Life Nutrition

    PRINCIPAL INVESTIGATOR
  • Smita Nambiar-Mann, PhD

    Danone Nutricia Early Life Nutrition

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2017

First Posted

May 3, 2017

Study Start

December 1, 2015

Primary Completion

November 1, 2016

Study Completion

December 31, 2016

Last Updated

April 14, 2020

Results First Posted

April 2, 2020

Record last verified: 2020-04