Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05649527
Other study ID # NBB 2022
Secondary ID QD03002020-A0353
Status Completed
Phase
First received
Last updated
Start date March 11, 2022
Est. completion date July 20, 2022

Study information

Verified date December 2022
Source Secteur Français des Aliments de l'Enfance
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The Nutri-Bébé 2022 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.


Description:

Infant's and young children's diet is a determining factor in their growth and development and may impact the occurrence of non-communicable diseases in the medium and long term. In this context, knowledge regarding the feeding practice and nutrients intake in children under 3 years of age is valuable, whether for the entire scientific and medical community or for the public authorities. Aiming to help achieving this objective, the SFAE has carried out a national observational survey every 8 years since 1981. The analysis of these data over time makes it possible to evaluate the intakes of different nutrients, to note possible nutritional insufficiencies or excesses, potentially linked to bad eating habits. On these bases, this repeatable survey can alert health professionals and help refine public health nutrition policy in France. A new edition was launched between March 2022 and July 2022 by an official polling institute, IPSOS. The sample includes more than 1,200 children aged from 0.5 to 35 months, distributed in 11 age-groups of equal importance, and living in metropolitan France (excluding Corsica). This is a cross-sectional observational survey. IPSOS 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 "). IPSOS ensures to conduct the surveys in accordance with the regulation on personal data protection and that respondents' personal identity is withheld. The SFAE has undertaken with the "Commission Nationale de l'Informatique et des Libertés" (CNIL), the French data protection authority) to respect the MR-003 reference methodology and is authorized to set up the processing of data without prior authorization from the CNIL (declaration n° 2220501 of 2020/12/18). Information on the children will be collected directly from the responding parents (primarily responsible for their child's diet). The collection of information will be carried out according to the following successive stages: - recruitment of families according to the quota method, provided they are fluent in French language and can use a computer. - To be included children should be born at term with a birth weight ≥ 2500 g and should have no intercurrent acute or chronic disease. - Face-to-face interview at home by an investigator to collect informed consent of the parents, sociodemographic data, child weight and height as well as information on children's eating habits. - Completion by the parent of an online consumption diary for a period of 3 non-consecutive days (2 weekdays and 1 weekend day, with at least one day of separation between each collection day). - Self-questionnaire to be completed by the responding parent on the child's diet, context and physical activities. The study conducted in 2022 is the sixth edition of the Nutri-Bébé survey.


Recruitment information / eligibility

Status Completed
Enrollment 1224
Est. completion date July 20, 2022
Est. primary completion date July 20, 2022
Accepts healthy volunteers
Gender All
Age group 15 Days to 35 Months
Eligibility Inclusion Criteria: - Child aged 0.5 to 35 months - Child whose responding parent, mainly responsible for his diet, agrees to complete the three stages of the survey (informed consent). - Child whose responding parent accepts the collection of birth weight, and the most recent weight and height in the health booklet. If the weight measurement has not been performed recently, the responding parent agrees to measure the weight of their child during the first interview. In this case, the presence of the child will be necessary. A recent weight corresponds to a measurement in the 15 days preceding inclusion for children aged 0-6 months, in the month preceding inclusion for children aged 6-12 months and in the two months preceding inclusion for those over one year old. - Child whose parents have been informed of the study orally and in writing, and have not objected to the participation of the child before its inclusion and to the collection of information concerning them. - In the case of the spouse of the responding parent, different from the second parent and living in the same household, no opposition to the collection of data concerning him Exclusion Criteria: - Child with a chronic or intercurrent pathology (including food allergies) - Child with a birth weight of less than 2.5 kg - Child whose last weight measurement in the health record is not recent enough AND whose parent refuses to measure his weight - Child having to take at least one meal at school during the 3 days of filling in the consumption diary - Child cared for by the crèche or by a third party and whose person responsible for meals refuses to send all the information (qualitative and quantitative) to the responding parent so that he can complete the consumption diary - Child whose sponsoring parent is under the age of 18, or is placed under guardianship or curatorship, or under legal protection

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France IPSOS Paris

Sponsors (3)

Lead Sponsor Collaborator
Secteur Français des Aliments de l'Enfance Centre de Recherche pour l'Etude et l'Observation des Conditions de Vie, IPSOS

Country where clinical trial is conducted

France, 

References & Publications (6)

Chouraqui 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. — View Citation

Chouraqui JP, Tavoularis G, Emery Y, Francou A, Hebel P, Bocquet M, Hankard R, Turck D. The French national survey on food consumption of children under 3 years of age - Nutri-Bebe 2013: design, methodology, population sampling and feeding practices. Public Health Nutr. 2018 Feb;21(3):502-514. doi: 10.1017/S1368980017002518. Epub 2017 Nov 2. — View Citation

Chouraqui JP, Tavoularis G, Simeoni U, Ferry C, Turck D. Food, water, energy, and macronutrient intake of non-breastfed infants and young children (0-3 years). Eur J Nutr. 2020 Feb;59(1):67-80. doi: 10.1007/s00394-018-1883-y. Epub 2019 Jan 16. — View Citation

Chouraqui JP, Tavoularis G, Turck D, Ferry C, Feillet F. Mineral and vitamin intake of infants and young children: the Nutri-Bebe 2013 survey. Eur J Nutr. 2020 Sep;59(6):2463-2480. doi: 10.1007/s00394-019-02093-3. Epub 2019 Sep 25. — View Citation

Chouraqui JP, Thornton SN, Seconda L, Kavouras SA. Total water intake and its contributors in infants and young children. Br J Nutr. 2021 Sep 9:1-11. doi: 10.1017/S0007114521003469. Online ahead of print. Erratum In: Br J Nutr. 2022 Jan 28;127(2):318-319. — View Citation

Chouraqui JP, Turck D, Tavoularis G, Ferry C, Dupont C. The Role of Young Child Formula in Ensuring a Balanced Diet in Young Children (1-3 Years Old). Nutrients. 2019 Sep 13;11(9):2213. doi: 10.3390/nu11092213. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Previous feeding Frequency in % of type of formula previously used March to July 2022
Other Screen exposure frequency in % of exposure to screens at different times of consumption March to July 2022
Other Screen exposure minutes/day spent in front of a screen March to July 2022
Other Physical activity minutes/day March to July 2022
Primary Age at inclusion months March to July 2022
Primary Weight kg March to July 2022
Primary Height cm March to July 2022
Primary Prevalence of children breastfed frequency in % March to July 2022
Primary Prevalence of children formula-fed frequency in % March to July 2022
Primary introduced complementary food specific baby food and adult type food frequency in % March to July 2022
Primary Age at introduced complementary food months March to July 2022
Primary Mean over 3 days of Food quantities g/day March to July 2022
Primary Mean over 3 days of macronutrient intake (protein, lipid, carbohydrate, fiber) g/d March to July 2022
Primary Mean over 3 days of Intakes of Linoleic-, alpha linolenic-acids, DHA, ARA, minerals (sodium, calcium, phosphorus, magnesium, iron, zinc), Vitamin B1,B2, B3, B6, C, E mg/d March to July 2022
Primary Mean over 3 days of intakes of Vitamin B9, B12, Retinol, Beta-caroten µg/d March to July 2022
Primary Vitamin A intake RE(Retinol Equivalent)/d March to July 2022
Secondary Influence of parents professional activity data on practice p value Scale : professions and socio-professional categories (PCS) minimum: inactive maximum: high socio-professional categories (executives and higher intellectual professions) March to July 2022
Secondary Influence of economic status on practice p value Household income scale Minimum : <1700€/months Maximum : >5400€/months March to July 2022
Secondary Influence of level of education on practice p value 3 level scale minimum: Primary or secondary education maximum: Higher education March to July 2022
Secondary Duration of previous breastfeeding months March to July 2022
See also
  Status Clinical Trial Phase
Completed NCT04502979 - Learning to Love Mealtime Together N/A
Completed NCT03334266 - Preventing Early Childhood Obesity, Part 2: Family Spirit Nurture, Prenatal - 18 Months N/A
Completed NCT03651258 - Facilitate the Transition From Passive Feeding to Active Feeding in Preterm Infants Through Early Play
Completed NCT05992753 - Mothers' Breast Milk Expression Experiences, Infant Feeding Attitudes and Perceived Social Support Levels
Completed NCT03332108 - Novel Approach To Improving Lactation Support With Mobile Health Technology N/A
Completed NCT03941392 - Nutritional Study in Spanish Pediatric Population
Completed NCT03949543 - The Timing of Main Meal Consumption Effect on Gut Microbiota and Host N/A
Not yet recruiting NCT05059574 - Breast Crawling,Breastfeeding Success and Mothers' Attitudes to Feeding Their Babies N/A
Completed NCT03242863 - Effect of Varying Proportions of Low and High Energy Dense Foods Over 5 Days in Preschool Children N/A
Completed NCT02996422 - Appalachians Together Restoring the Eating Environment: Improving Healthy Diet in Rural Appalachian Kentucky N/A
Completed NCT03127579 - Family Meal Duration and Children's Eating Behavior N/A
Enrolling by invitation NCT03755999 - A Cue-based Developmental Approach Toward the Preterm Infants During Feeding Transition Period N/A
Recruiting NCT03439618 - Comparison of Time-restricted Feeding and Continuous Feeding in Critically Ill Patients N/A
Completed NCT03488680 - Effectiveness of Behavior Change Communication in Improving Feeding Practices, Nutritional and Health Status of Infants N/A
Recruiting NCT04960969 - The Effects of Time-Restricted Eating Model N/A
Completed NCT02930642 - Food Insecurity, Obesity, and Impulsive Food Choice N/A
Completed NCT03926065 - Variations in Palatability and Portion Size of Vegetables on Meal Intake of Preschool Children N/A
Completed NCT03886428 - The Influence of Satiation Measures on the Portion Size Effect N/A
Completed NCT03025815 - Effects of the Oral Stimulation Program in Extreme Preterm Infants N/A
Completed NCT02347527 - Neuronal and Behavioral Effects of Implicit Priming in Obese Individuals N/A