NutritionNCT03138330

Validation of a Food Frequency Questionnaire

An observational study of Nutrition, run by Danone Asia Pacific Holdings Pte, Ltd..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 15 to 36 monthsHealthy volunteers can take part
Conditions the study is for: Nutrition
What is being tested?: this study is observational, it is not an intervention
How many people: 95 participants
Where: No sites listed yet
Study dates: Dec 2015to 31 Dec 2016
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 15 to 36 months
All sexes
Healthy volunteers accepted
Child

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

Who may be able to join

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

Who cannot join

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.

About this study

Official title: 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.

Read the 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

Conditions: Nutrition
Being tested: this study is observational, it is not an intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

this study is observational, it is not an interventionOther

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: up to 1 month

Secondary outcomes (1)

Salivary Inflammatory Biomarkers
C-reactive protein, salivary IgA, alpha amylase
Measured: up to 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 201531 Dec 2016

First posted3 May 2017
Study startDec 2015
Primary completionNov 2016
Study completion31 Dec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for NutritionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 95 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03138330
Sponsor's protocol ID: SGP. 1.A/A/3, PIEC2015/023.
Status last verified: Apr 2020
First submitted: 13 Feb 2017
Last updated: 14 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: the whole data set (without traceability to the participant) may be available for other researchers for secondary analyses

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.
PubMed 32153903

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Validation of Dietary Patterns and Inflammatory Salivary Biomarkers Among Healthy Toddlers of 15-36 Months Old in Singapore
ClinicalTrials.gov ID: NCT03138330
Acronym / sponsor ID: SGP. 1.A/A/3, PIEC2015/023.
Conditions: Nutrition
Study type: Observational
Recruitment status: Completed
Enrolment: 95 participants (actual)
Lead sponsor: Danone Asia Pacific Holdings Pte, Ltd.Industry (pharma, biotech, devices)
Study start: Dec 2015 (actual)
Primary completion: Nov 2016 (actual)
Study completion: 31 Dec 2016 (actual)
First posted: 3 May 2017 (actual)
Results: Posted 2 Apr 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Cohort
Time perspective: Cross-sectional

Who may qualify

Ages: 15 to 36 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child
Study population: children who are aged 15-36 months and of Chinese, Indian or Malay ethnicity

Key inclusion criteria (2 listed)

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

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
this study is observational, it is not an intervention	Other	–

Primary outcome

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.

1 secondary outcome

Salivary Inflammatory Biomarkers
Time frame: up to 1 month

Results and safety

Results posted to the registry on 2 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FFQ Group	95	91

Primary outcome: Validated Food Frequency Questionnaire

Time frame: up to 1 month. Number. Unit: Pearson correlation

Measure	FFQ Group n = 91
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

Population analysed: 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.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FFQ Group	0 of 91 (0%)	0 of 91 (0%)	0 of 91

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32153903Allan 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.
Individual participant dataSharing planned: Undecided. the whole data set (without traceability to the participant) may be available for other researchers for secondary analyses

Related trials for Nutrition

Active, not recruiting
Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial
Bariatric Surgery Candidate, Obesity
RecruitingPhase 3
Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
Heart Failure With Preserved Ejection Fraction, Heart Failure With Mildly Reduced Ejection Fraction
Not yet recruiting
Evaluation of the Axomove Therapy Medical Device to Facilitate Adapted Physical Activity for Patients With Obesity
Obese Adults
Not yet recruiting
Efficacy, Safety, and Treatment Satisfaction of Once-Weekly Tirzepatide in Obese Type 2 Diabetic Patients
Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Not yet recruiting
Preserving Muscle Mass During Incretin-Induced Weight Loss
Obesity (BMI > 35)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Elena Sandalova, PhD principal investigator

Danone Nutricia Early Life Nutrition

Smita Nambiar-Mann, PhD study chair

Danone Nutricia Early Life Nutrition

Questions about this trial

What is this clinical trial studying?

An observational study of Nutrition, run by Danone Asia Pacific Holdings Pte, Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Validated Food Frequency Questionnaire (time frame: up to 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03138330, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020.