Food ConsumptionNBB2013NCT03327415
Nutri-Bébé 2013 Survey on Food Consumption of Infants and Young Children
An observational study of Food Consumption and Infants, run by Secteur Français des Aliments de l'Enfance at 1 site in France.
Trial summary
The Nutri-Bébé 2013 survey is an observational cross-sectional study aiming to update food consumption, practices and nutrient intakes in children under 3 years of age in metropolitan France. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Food Consumption, Infants, Toddlers
- How many people
- 1,192 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jan 2013to 15 Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- Child, Adult, Older adult
Study population: The present survey is based on a randomly selected sample with socio-demographic characteristics similar to the general population living in mainland France (i.e. excluding Corsica, overseas departments, regions, and communities, and New Caledonia). A quota sampling method was used: sampling wastratified by residential area, size of the urban agglomeration, infant gender, mother's professional activity, occupational and socio-occupational status and adjusted for these different characteristics. This stratification was based on the population characteristics of the 2002 census of the National Institute for Statistics and Economic Research (INSEE, Institut National de la Statistique et des Etudes Economiques).
Who may be able to join
- informed parental consent to participate in the study,
- absence of intercurrent or chronic disease
- birth weight above 2.5 kg
Who cannot join
- Non compliance withe the study protocol
- For outcome 3 analysis (intakes), reported weight inconsistent with the child's age (> or <3 SD)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The French National Survey on Food Consumption of Children Under 3 Years of Age
The Nutri-Bébé 2013 survey is an observational cross-sectional study aiming to update food consumption, practices and nutrient intakes in children under 3 years of age in metropolitan France.
Read the detailed description
Nutri-Bébé 2013 is the 5th edition of a survey conducted every 8 years since 1981 by the SFAE. The Nutri-Bébé 2013 survey is an observational cross-sectional study conducted in children living in France aged 15 days to 35 months by an official polling institute, the TNS Sofres according to the guidelines laid down in the Declaration of Helsinki. TNS Sofres fulfills the following standards and industry requirements (ESOMAR professional code of conduct and standards, ISO 20252:2012 international standard for market, opinion and social research, French data protection act (loi "informatique et libertés "). TNS Sofres ensures to conduct the surveys in accordance with the regulation on personal data protection and that respondents' personal identity is withheld. Moreover TNS Sofres appointed a data protection officer, the "Correspondant Informatique et Libertés", who is the point of contact between the "Commission Nationale de l'Informatique et des Libertés" (CNIL), the French data protection authority) and the company. The company is thus exempted, of the notification process to the CNIL. Given the type of survey conducted, namely a survey of consumption, and the characteristics developed above, the study does not require any opinion of the ethics committee.
The survey includes a section on eating behaviours and a section on food consumption.
After giving their informed consent, parents had to record the food consumption during 3 non-consecutive days (2 week days and one weekend day)framed by two face-to-face interviews,. A second visit occurred seven days later to verify and complete the diary if necessary, and conduct a face-to-face interview with the mother about eating habits over the survey period. Both interviews were recorded using CAPI® software (Computer Assisted Personal Interviews, http://www.soft-concept.com). During this visit, the child was weighed (naked, with a clean diaper or underwear) using a Tefal PREMISS PP1000VO scale with a precision of 100 g.
The child's food consumption diary was completed between the two visits of the TNS Sofres investigator. The person in charge of the child was trained to qualitatively and quantitatively report all liquid and solid foods consumed and all drinks, by specifying the exact name of the product, its potential trademark or whether it was "homemade". The type of water consumed was noted as being either "bottled" or "tap". The type (breakfast, morning snack, lunch, afternoon snack, dinner, nocturnal food intake) and timing of food consumption were collected. If applicable, vitamin, mineral or medicine supplements were noted. During the second visit the investigator reviewed thoroughly the record with the caregiver and checked the way of reporting the quantities as well as the interpretation of the photographic tool kit in order to be as close as possible to reality.
- Conditions
- Food Consumption, Infants, Toddlers
- Keywords
- Children, Food practice, Food consumption, Nutrient intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Age groups | Eleven age groups that took into account the previous surveys and the key stages of child development were defined: 15 days to 3 months, 4, 5, 6, 7, 8-9, 10-11, 12- 17, 18-23, 24-29, and 30-35 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age at inclusion
months
Measured: January to april 2013
Weight at inclusion
kg
Measured: January to april 2013
Prevalence of socio-demographic condition, feeding practice, consumption energy contribution,
frequency in %
Measured: January to april 2013
Time of introducing or withdrawing a food
months
Measured: history of feeding before being included in the survey
Mean over 3 days of Food quantities and macronutrient intake (water, protein, lipid, carbohydrate, fiber)
g/d
Measured: January to april 2013
Mean over 3 days of Intakes of Linoleic-, alpha linolenic-acids, DHA, ARA, minerals (sodiu, calcium, phosphorus, magnesium, iron, zinc), Vitamin B1,B2, B3, B6, C, E
mg/d
Measured: January to april 2013
Mean over 3 days of intakes of Vitamin B9, B12, Retinol, Beta-caroten
micro g/d
Measured: January to april 2013
Vitamin A intake
RE(Retinol Equivalent)/d
Measured: January to april 2013
Secondary outcomes (2)
Nutrient intakes per kilogram body weight
unit/kg/d
Measured: January to april 2013
Comparison with 2005 data
p value
Measured: 2013 vs 2005
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start3 Jan 2013
- Primary completion21 Apr 2013
- Study completion15 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Food ConsumptionStudies 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
- 1,192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Secteur Français des Aliments de l'Enfance
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TNS Sofres polling institute, Centre de Recherche pour l'Etude et l'Observation des Conditions de Vie
- Responsible party
- Sponsor
- Investigators
- Gabriel TAVOULARIS, Engineer,MSc, Principal investigator, CREDOCYves EMERY, MSc, Principal investigator, TNS SofresJean-Pierre CHOURAQUI, MD, MSc, Principal investigator, CHUV LausanneMagali BOCQUET, Engineer,MSc, Study director, Secteur Français des Aliments de l'Enfance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03327415
- Sponsor's protocol ID
- Nutri-Bébé SFAE 2013
- Acronym
- NBB2013
- Status last verified
- Oct 2017
- First submitted
- 19 Oct 2017
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: To be shared is the global report of results on each items (food practices, food consumption, nutrients intakes), according to age groups.
Publications
Chouraqui JP, Renella R, Turck D. Assessment of Dietary Iron Intake and Sources in Early Childhood in a Nationally Representative Cross-Sectional Survey. J Acad Nutr Diet. 2024 Jul;124(7):823-832.e1. doi: 10.1016/j.jand.2023.12.009. Epub 2023 Dec 22.
PubMed 38142742Chouraqui JP, Darmaun D, Salmon-Legagneur A, Shamir R. Protein intake pattern in non-breastfed infants and toddlers: A survey in a nationally representative sample of French children. Clin Nutr. 2022 Feb;41(2):269-278. doi: 10.1016/j.clnu.2021.12.006. Epub 2021 Dec 8.
PubMed 34998033
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The French National Survey on Food Consumption of Children Under 3 Years of Age
- ClinicalTrials.gov ID
- NCT03327415
- Acronym / sponsor ID
- NBB2013 / Nutri-Bébé SFAE 2013
- Conditions
- Food Consumption, Infants, Toddlers
- Keywords
- Children, Food practice, Food consumption, Nutrient intake
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,192 participants (actual)
- Lead sponsor
- Secteur Français des Aliments de l'EnfanceIndustry (pharma, biotech, devices)
- Collaborators
- TNS Sofres polling institute, Centre de Recherche pour l'Etude et l'Observation des Conditions de Vie
- Study start
- 3 Jan 2013 (actual)
- Primary completion
- 21 Apr 2013 (actual)
- Study completion
- 15 Feb 2015 (actual)
- First posted
- 31 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Nutri-Bébé 2013 survey is an observational cross-sectional study aiming to update food consumption, practices and nutrient intakes in children under 3 years of age in metropolitan France.
Detailed description
Nutri-Bébé 2013 is the 5th edition of a survey conducted every 8 years since 1981 by the SFAE. The Nutri-Bébé 2013 survey is an observational cross-sectional study conducted in children living in France aged 15 days to 35 months by an official polling institute, the TNS Sofres according to the guidelines laid down in the Declaration of Helsinki. TNS Sofres fulfills the following standards and industry requirements (ESOMAR professional code of conduct and standards, ISO 20252:2012 international standard for market, opinion and social research, French data protection act (loi "informatique et libertés "). TNS Sofres ensures to conduct the surveys in accordance with the regulation on personal data protection and that respondents' personal identity is withheld. Moreover TNS Sofres appointed a data protection officer, the "Correspondant Informatique et Libertés", who is the point of contact between the "Commission Nationale de l'Informatique et des Libertés" (CNIL), the French data protection authority) and the company. The company is thus exempted, of the notification process to the CNIL. Given the type of survey conducted, namely a survey of consumption, and the characteristics developed above, the study does not require any opinion of the ethics committee.
The survey includes a section on eating behaviours and a section on food consumption.
After giving their informed consent, parents had to record the food consumption during 3 non-consecutive days (2 week days and one weekend day)framed by two face-to-face interviews,. A second visit occurred seven days later to verify and complete the diary if necessary, and conduct a face-to-face interview with the mother about eating habits over the survey period. Both interviews were recorded using CAPI® software (Computer Assisted Personal Interviews, http://www.soft-concept.com). During this visit, the child was weighed (naked, with a clean diaper or underwear) using a Tefal PREMISS PP1000VO scale with a precision of 100 g.
The child's food consumption diary was completed between the two visits of the TNS Sofres investigator. The person in charge of the child was trained to qualitatively and quantitatively report all liquid and solid foods consumed and all drinks, by specifying the exact name of the product, its potential trademark or whether it was "homemade". The type of water consumed was noted as being either "bottled" or "tap". The type (breakfast, morning snack, lunch, afternoon snack, dinner, nocturnal food intake) and timing of food consumption were collected. If applicable, vitamin, mineral or medicine supplements were noted. During the second visit the investigator reviewed thoroughly the record with the caregiver and checked the way of reporting the quantities as well as the interpretation of the photographic tool kit in order to be as close as possible to reality.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Age groups | – | –Eleven age groups that took into account the previous surveys and the key stages of child development were defined: 15 days to 3 months, 4, 5, 6, 7, 8-9, 10-11, 12- 17, 18-23, 24-29, and 30-35 months. |
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- The present survey is based on a randomly selected sample with socio-demographic characteristics similar to the general population living in mainland France (i.e. excluding Corsica, overseas departments, regions, and communities, and New Caledonia). A quota sampling method was used: sampling wastratified by residential area, size of the urban agglomeration, infant gender, mother's professional activity, occupational and socio-occupational status and adjusted for these different characteristics. This stratification was based on the population characteristics of the 2002 census of the National Institute for Statistics and Economic Research (INSEE, Institut National de la Statistique et des Etudes Economiques).
Key inclusion criteria (3 listed)
- informed parental consent to participate in the study,
- absence of intercurrent or chronic disease
- birth weight above 2.5 kg
Key exclusion criteria (2 listed)
- Non compliance withe the study protocol
- For outcome 3 analysis (intakes), reported weight inconsistent with the child's age (> or <3 SD)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Age at inclusion
Time frame: January to april 2013
months
Weight at inclusion
Time frame: January to april 2013
kg
Prevalence of socio-demographic condition, feeding practice, consumption energy contribution,
Time frame: January to april 2013
frequency in %
Time of introducing or withdrawing a food
Time frame: history of feeding before being included in the survey
months
Mean over 3 days of Food quantities and macronutrient intake (water, protein, lipid, carbohydrate, fiber)
Time frame: January to april 2013
g/d
Mean over 3 days of Intakes of Linoleic-, alpha linolenic-acids, DHA, ARA, minerals (sodiu, calcium, phosphorus, magnesium, iron, zinc), Vitamin B1,B2, B3, B6, C, E
Time frame: January to april 2013
mg/d
Mean over 3 days of intakes of Vitamin B9, B12, Retinol, Beta-caroten
Time frame: January to april 2013
micro g/d
Vitamin A intake
Time frame: January to april 2013
RE(Retinol Equivalent)/d
2 secondary outcomes
Nutrient intakes per kilogram body weight
Time frame: January to april 2013
Comparison with 2005 data
Time frame: 2013 vs 2005
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2017.
- Derived from this study: PubMed 38142742Chouraqui JP, Renella R, Turck D. Assessment of Dietary Iron Intake and Sources in Early Childhood in a Nationally Representative Cross-Sectional Survey. J Acad Nutr Diet. 2024 Jul;124(7):823-832.e1. doi: 10.1016/j.jand.2023.12.009. Epub 2023 Dec 22.
- Derived from this study: PubMed 34998033Chouraqui JP, Darmaun D, Salmon-Legagneur A, Shamir R. Protein intake pattern in non-breastfed infants and toddlers: A survey in a nationally representative sample of French children. Clin Nutr. 2022 Feb;41(2):269-278. doi: 10.1016/j.clnu.2021.12.006. Epub 2021 Dec 8.
- Individual participant dataSharing planned: No. To be shared is the global report of results on each items (food practices, food consumption, nutrients intakes), according to age groups.
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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.
Gabriel TAVOULARIS, Engineer,MSc principal investigator
CREDOC
Yves EMERY, MSc principal investigator
TNS Sofres
Jean-Pierre CHOURAQUI, MD, MSc principal investigator
CHUV Lausanne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Consumption and Infants, run by Secteur Français des Aliments de l'Enfance at 1 site in France.
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 3 inclusion and 2 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 31 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Age at inclusion (time frame: January to april 2013). The study lists 8 primary outcomes in all. 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 NCT03327415, which also lists 2 linked publications.
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 31 Oct 2017.