Polish Infants and Toddler Nutritional Study

NCT06417151 | Enrolling By Invitation

• 2 other identifiers: 40/2024RG 1/2023
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

A cross-sectional study representative of the Polish population of children aged 5 months to 6 years conducted in the cross-sectional study model, the main objective of which is to assess the nutritional value of the diet of children aged from 5 months to 6 years with regard to the basic macronutrients: protein (P), fat (F), carbohydrates (C). The study will include: dietary interviews, which will include the Food Frequency Questionnaire questionnaire (FFQ) and a 3-day food diary, as well as anthropometric measurements. The study will involve 1,000 children who will be selected by a random draw based on government database. The survey will be conducted by trained field interviewers - training will be provided by a dietician and an anthropologist. The study also included validation of the FFQ questionnaire.

Conditions

Diet Habit; Dietary Habits; Diet, Healthy; Children; Child; Nutritional Deficiency; Nutritional Status; Macronutrients; Consumption; Dietary Assessment; Cross-sectional Study

Keywords

diet; habit; nutritional; children; cross-sectional study; macronutrients; child; dietary assessment; consumption

Outcome Measures

Primary Outcomes (1)

• Macronutrient intake

  Nutritional value of the diet in terms of macronutrients: protein, fat, carbohydrates

  three-day consumption

Secondary Outcomes (3)

• Other nutrients intake

  three-day consumption

• Population risk of nutritional deficiencies

  the last 14 days of the FFQ

• Nutritional status

  At the time of the dietary interview

Other Outcomes (5)

• Dietary regime

  the last 14 days of the FFQ

• Frequency of food consumption

  the last 14 days of the FFQ

• Dietary Patterns

  the last 14 days of the FFQ

Study Arms (1)

Healthy children between the ages of 5 months and 6 years of Polish nationality

Eligibility Criteria

• Age: 5 Months - 72 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

It will be children randomly selected from different socio-economic backgrounds. The sample will be drawn on the basis of PESEL numbers. The children surveyed will come from the whole area of Poland with territorial representativeness. The respondents in the survey will be parents or legal guardians of the drawn children. The division into age groups is based on the key stages of a child\'s development, i.e. up to 1 year of age (n=300), 1-3 years of age (n=400), after 3 years of age and up to 6 years of age (n=300).

You may qualify if:

• healthy children aged 5 months to 72 months born at term
• polish nationality

You may not qualify if:

• Presence of chronic diseases affecting nutritional status (metabolic diseases - e.g. diabetes, phenylketonuria, cystic fibrosis; diseases of the digestive system - e.g. coeliac disease, Crohn\'s disease; kidney disease, liver disease or other disorders affecting the absorption of nutrients)
• Use of elimination diets for medical reasons (e.g. food allergy)
• Developmental disorders that may affect nutrition (e.g. genetic diseases, prematurity)
• Acute infectious disease or other illness requiring hospital treatment within 3 months prior to the start of the study
• Condition after a prolonged hospital stay (\>10 days) within 6 months prior to the study
• Surgical procedures performed in the last 3 months that could affect nutritional status

Sponsors & Collaborators

• Fundacja Nutricia: lead
• Institute of Mother and Child, Warsaw, Poland: collaborator

Study Sites (1)

Mothers and Child Institute

Warsaw, Masovian Voivodeship, 01-211, Poland

Location

Related Publications (15)

• Weker H, Brudnicka E, Baranska M, Rowicka G, Strucinska M, Wiech M, Dylag H, Klemarczyk W, Socha P, Mazur J. Dietary Patterns of Children Aged 1-3 Years in Poland in Two Population Studies. Ann Nutr Metab. 2019;75(1):66-76. doi: 10.1159/000501422. Epub 2019 Jul 2.

  PMID: 31266006 BACKGROUND

• Weker H, Baranska M, Riahi A, Strucinska M, Wiech M, Rowicka G, Dylag H, Klemarczyk W, Bzikowska A, Socha P. Nutrition of infants and young children in Poland - Pitnuts 2016. Dev Period Med. 2017;21(1):13-28. doi: 10.34763/devperiodmed.20172101.1328.

  PMID: 28551688 BACKGROUND

• Schroeder N, Rushovich B, Bartlett E, Sharma S, Gittelsohn J, Caballero B. Early Obesity Prevention: A Randomized Trial of a Practice-Based Intervention in 0-24-Month Infants. J Obes. 2015;2015:795859. doi: 10.1155/2015/795859. Epub 2015 May 11.

  PMID: 26078877 BACKGROUND

• McCarthy EK, Ni Chaoimh C, Hourihane JO, Kenny LC, Irvine AD, Murray DM, Kiely M. Iron intakes and status of 2-year-old children in the Cork BASELINE Birth Cohort Study. Matern Child Nutr. 2017 Jul;13(3):e12320. doi: 10.1111/mcn.12320. Epub 2016 Aug 9.

  PMID: 27501864 BACKGROUND

• Lioret S, Betoko A, Forhan A, Charles MA, Heude B, de Lauzon-Guillain B; EDEN Mother-Child Cohort Study Group. Dietary patterns track from infancy to preschool age: cross-sectional and longitudinal perspectives. J Nutr. 2015 Apr;145(4):775-82. doi: 10.3945/jn.114.201988. Epub 2015 Jan 28.

  PMID: 25833780 BACKGROUND

• Hojsak I, Bronsky J, Campoy C, Domellof M, Embleton N, Fidler Mis N, Hulst J, Indrio F, Lapillonne A, Molgaard C, Vora R, Fewtrell M; ESPGHAN Committee on Nutrition. Young Child Formula: A Position Paper by the ESPGHAN Committee on Nutrition. J Pediatr Gastroenterol Nutr. 2018 Jan;66(1):177-185. doi: 10.1097/MPG.0000000000001821.

  PMID: 29095351 BACKGROUND

• Hamner HC, Perrine CG, Scanlon KS. Usual Intake of Key Minerals among Children in the Second Year of Life, NHANES 2003-2012. Nutrients. 2016 Jul 30;8(8):468. doi: 10.3390/nu8080468.

  PMID: 27483313 BACKGROUND

• Finn K, Callen C, Bhatia J, Reidy K, Bechard LJ, Carvalho R. Importance of Dietary Sources of Iron in Infants and Toddlers: Lessons from the FITS Study. Nutrients. 2017 Jul 11;9(7):733. doi: 10.3390/nu9070733.

  PMID: 28696361 BACKGROUND

• Fidler Mis N, Braegger C, Bronsky J, Campoy C, Domellof M, Embleton ND, Hojsak I, Hulst J, Indrio F, Lapillonne A, Mihatsch W, Molgaard C, Vora R, Fewtrell M; ESPGHAN Committee on Nutrition:. Sugar in Infants, Children and Adolescents: A Position Paper of the European Society for Paediatric Gastroenterology, Hepatology and Nutrition Committee on Nutrition. J Pediatr Gastroenterol Nutr. 2017 Dec;65(6):681-696. doi: 10.1097/MPG.0000000000001733.

  PMID: 28922262 BACKGROUND

• Lapillonne A, Bronsky J, Campoy C, Embleton N, Fewtrell M, Fidler Mis N, Gerasimidis K, Hojsak I, Hulst J, Indrio F, Molgaard C, Moltu SJ, Verduci E, Domellof M; ESPGHAN Committee on Nutrition. Feeding the Late and Moderately Preterm Infant: A Position Paper of the European Society for Paediatric Gastroenterology, Hepatology and Nutrition Committee on Nutrition. J Pediatr Gastroenterol Nutr. 2019 Aug;69(2):259-270. doi: 10.1097/MPG.0000000000002397.

  PMID: 31095091 BACKGROUND

• Deren K, Weghuber D, Caroli M, Koletzko B, Thivel D, Frelut ML, Socha P, Grossman Z, Hadjipanayis A, Wyszynska J, Mazur A. Consumption of Sugar-Sweetened Beverages in Paediatric Age: A Position Paper of the European Academy of Paediatrics and the European Childhood Obesity Group. Ann Nutr Metab. 2019;74(4):296-302. doi: 10.1159/000499828. Epub 2019 Apr 23.

  PMID: 31013493 BACKGROUND

• Csolle I, Felso R, Szabo E, Metzendorf MI, Schwingshackl L, Ferenci T, Lohner S. Health outcomes associated with micronutrient-fortified complementary foods in infants and young children aged 6-23 months: a systematic review and meta-analysis. Lancet Child Adolesc Health. 2022 Aug;6(8):533-544. doi: 10.1016/S2352-4642(22)00147-X. Epub 2022 Jun 24.

  PMID: 35753314 BACKGROUND

• Akkermans MD, Eussen SR, van der Horst-Graat JM, van Elburg RM, van Goudoever JB, Brus F. A micronutrient-fortified young-child formula improves the iron and vitamin D status of healthy young European children: a randomized, double-blind controlled trial. Am J Clin Nutr. 2017 Feb;105(2):391-399. doi: 10.3945/ajcn.116.136143. Epub 2017 Jan 4.

  PMID: 28052885 BACKGROUND

• Ahluwalia N, Herrick KA, Rossen LM, Rhodes D, Kit B, Moshfegh A, Dodd KW. Usual nutrient intakes of US infants and toddlers generally meet or exceed Dietary Reference Intakes: findings from NHANES 2009-2012. Am J Clin Nutr. 2016 Oct;104(4):1167-1174. doi: 10.3945/ajcn.116.137752. Epub 2016 Sep 14.

  PMID: 27629049 BACKGROUND

• Sawicki M, Kowalkowska J, Kulaga Z, Socha P, Swiader-Lesniak A, Swiecicka-Ambroziak A, Szajewska H, Wadolowska L, Weker H. Assessment of dietary practices and nutritional status of children aged 5 to 72 months: study protocol of a nationwide Polish cross-sectional study (PITNUTS 2024). BMJ Open. 2025 Nov 19;15(11):e100921. doi: 10.1136/bmjopen-2025-100921.

  PMID: 41263840 DERIVED

MeSH Terms

Conditions

Feeding Behavior; Malnutrition; Habits

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 16, 2024
• Study Start: August 1, 2024
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)