Polish Infants and Toddler Nutritional Study

Background:

Correct nutrition is one of the most important factors for the optimal psychosomatic development of the child. Both short- and long-term observations emphasise the importance of nutritional factors in the childs development already in the foetal period and in the first two years of life (the idea of the first 1,000 days of life). Research shows that the components of the model of safe child nutrition, such as exclusive breastfeeding of the child in the first six months of life, breastfeeding and skilful expansion of the diet in the second six months of life and appropriate nutritional management in the post-natal and pre-school period form the basis for normal growth, the formation of healthy eating behaviour and also reduce the risk of diet-related diseases in adulthood. Parental awareness towards skilful dietary expansion and the introduction of foods with a favourable nutrient profile depends to a large extent on effective nutrition education (PITNUTS 2016). Data on infant and child nutrition in Poland are limited. The PITNUTS study, conducted in Poland in 2016 on a randomly selected sample (N=1059), found that the diet of infants and children aged 5-36 months deviated from the dietary recommendations. An analysis of the nutrient profile in the diets of postnatal children showed a varied energy value and a significantly higher protein supply in relation to population norms (Weker et al, 2017; Weker et al, 2019). A survey conducted during the COVID-19 pandemic by Horvath et al. also showed a discrepancy between mothers; nutritional knowledge and feeding practices of infants aged 4-12 months (Horvath et al, 2022). Inappropriate feeding practices translated into nutritional status, which was confirmed in a study conducted in Poland as part of the National Health Programme 2016-2020 (Kułaga ed. 2021). On the other hand, in a nationwide study conducted in 2017-2020 among pre-school and school children, abnormal body weight was found in more than 30% of respondents (PAN 2023). Observational studies conducted worldwide have confirmed the short- and long-term effects of nutrition on the nutritional status of infants and young children. A beneficial effect of diets including fortified foods on reducing the risk of deficiencies of nutrients such as iron, vitamin D and calcium and the energy balance of the diet has also been found (Lioret et al 2015, Schroeder et al 2015, Ahluwalia et al 2016, Hammer et al 2016, Akkermans et al 2017, McCarthy 2017, Finn et al 2017, Csölle Iet al 2022).

In recent years, updated and revised dietary recommendations for the paediatric population, for three age groups, have been issued, based on the latest reports and international recommendations (Fewtrell et al 2017, Hojsak et al 2018, Fidler et al 2017, Dereń et al 2019).

Updated Guidelines of nutrition for healthy infants - Position statement of the Polish Society of Gastroenterology, Hepatology and Child Nutrition, in line with current ESPGHAN guidelines, the Position statement of the Committee on Human Nutrition Science of the Polish Academy of Sciences on the principles of nutrition for children aged 1-3 years and the Position statement of the Committee on Human Nutrition Science of the Polish Academy of Sciences on the principles of nutrition for pre-school (4-6 years) and early school age children (7-9 years) were developed. Changes to the guidelines included, among others, the introduction of allergenic foods, the serving of plant-based beverages and fruit juices (in the first year of life), and the updating of safe nutrition models in relation to food rations (in the 1-3 years and 4-9 years groups) (Szajewska H. et al, 2021, PAN 2022, PAN 2023).

Understanding current practices and challenges in infant and child nutrition will allow better tailoring of nutrition education interventions targeting parents and children. The aim of this study is to assess the diet and nutritional status of infants and children aged 5-72 months, the consistency of feeding practices with current recommendations and to compare with the results of the previous PITNUTS survey conducted in 2016.

On this basis, investigators hypothesise that children aged 5 months to 6 years are not fed according to the principles of proper nutrition (Szajewska et al. 2021 , Weker et al. 2022 , Weker et al.2023 , Jarosz M. et al. 2020 \], and their nutritional status assessed on the basis of anthropometric measurements deviates from the norms based on the WHO centile grids for children 0-5 and for children ≥3 years of age OLA-OLAF (Kułaga 2015).

Objectives:

The main objective of the study is to assess the nutritional value of the diet of children aged 5 months to 6 years with regard to the main macronutrients: protein (B), fat (T), carbohydrates (C). In addition, specific objectives were also identified:

* to assess the nutritional value of the diet in terms of other nutrients: animal protein, vegetable protein, digestible carbohydrates, dietary fibre, lactose, sucrose, starch, polyunsaturated fatty acids (PUFA), monounsaturated fatty acids (MUFA), saturated fatty acids (SFA), vitamins, minerals * assessment of population risk of deficiencies based on nutrient intakes (cut-off point method \[Estimated Average Requirement (EAR)/Adequate Intake (AI)\], with particular reference to vitamin D, LCPUFA and protein * assessment of nutritional status based on Z-score BMI, i.e. body mass index related to age and sex

Study Population:

The study will include healthy children aged 5 months to 6 years.

Sample sizes were determined in two ways:

First was ensuring that the results of the study can be generalized to the populations of children aged 5-12 months, 13-36 months and 37-72 months with a 95% confidence interval, and that the maximum assumed error (difference between the population parameter and the sample statistic) will not exceed 6%. The sample will be selected in such a way as to ensure both representativeness for the whole population (infants and children from the whole country at a specific age: 5 months - 6 years). The study will include all drawn children whose parents agree to participate in the study (informed consent form, parents/guardians of children drawn for the study will be offered a quota voucher to be used at a selected retail chain). The draw will be carried out in strata taking into account the age of the child and the type of municipality, and within a stratum, the draw of a specific bundle (municipality) will be carried out with probability proportional to the number of children aged up to six years old in the municipality (based on CSO data - Census 2021). As a result, also the number of bundles per province within the stratum will be roughly proportional to the number of children in the province and the type of municipality. The sample will comprise 300 infants aged 5-12 months, 400 children aged 13-36 months and 300 children aged 37-72 months. Infants up to the age of one year will be further stratified (5-6, 7-9 and 10-12 months with 100 infants each), children aged 13-36 months will be stratified by year: 13- 24 and 25-36 months (200 babies each), and children over 36 months into annual strata of 100 babies each. This scheme ignores the not-quite-uniform distribution of births across months and years, but taking it into account would be extremely difficult, as such detailed population data, even if it were possible to obtain in real time, loses relevance very quickly. The simplification adopted will have minimal impact on the quality of the sample, but will allow a minimum sample size of 100 interviews to be maintained for the narrowest ranges. Children will be selected on the assumption that they will be aged 4, 6, 9, 12, 24, 36, 48 and 60 months respectively on the day of the survey. The need to complete the survey in a short period of time due to sample obsolescence (the age of the children had to be within the assumed ranges) necessitates drawing an appropriately paired sample and providing an adequate reserve sample in case the child/carer did not agree to participate in the survey or was unavailable on the survey date. The municipality was used as the primary sampling unit. For operational reasons, two parallel representative samples of the original sampling units (municipalities) of 100 units each (sample A and sample B) will be drawn. In municipalities drawn into the first group (sample A), one interview each will be conducted with parents/carers of children from age cohorts 1a, 1c, 2a, 2b, 3b (subgroup designations as in the Table below). In municipalities from the second group (sample B) - one interview each with parents/carers of children from subgroups: 1b, 2a, 2b, 3a, 3c. This will yield as many interviews per age cohort as below:

1. Infants (n=300) 1a. Infants 5-6 months (n=100) 1b. Infants 7-9 months (n=100) 1c. Infants 10-12 months (n=100) 2. Children 13-36 months (n=400) 2a. Children 13-24 months (n=200) 2b. Children 25-36 months (n=200) 3. Children 37-72 months (n=300) 3a. Children 37-48 months (n=100) 3b. Children 49-60 months (n=100) 3c. Children 61-72 months (n=100)

In addition to ensuring representativeness, abundance was counted for the primary endpoint. For this purpose, P, F, C intake data from PITNUTS 2016 were used (mean and SD) for children 5-6 months, as this age group had the greatest variability in macronutrient intake. An acceptable error of 15% in the estimation of the mean value was assumed; the formulae for the quantitative data (mean and SD) were applied in the design of the descriptive studies. The results of these calculations indicated a minimum sample N calculated for the intake of P: 97; F: 91; C: 94 individuals. Therefore, the assumed sample size of 100 children aged 5-6 months is sufficient with an acceptable 15% error in the estimation of the mean value in this age group. On this a priori basis, similar counts were used for the other age groups, i.e. 100 or 200 individuals each. From the intake data obtained in PITNUTS 2016 and the a priori counts (100 or 200 individuals each), it was concluded that such counts in the age groups 7-9 mo, 10-12 mo and 5-12 mo would allow an estimate of the mean intake of P, F, C with an acceptable error in the range of 5-10%. After the fact, the power of the test for intake will be calculated from the intake data obtained in PITNUTS 2024 (to determine the power of inference in the main study) for the realised counts:

* P, F, C in the age groups 13-36 mo, 37-72 mo. * other nutrients in all age groups * percentage of people at risk of deficiency

In summary, the numbers of children aged 5-72 months in each age range will be:

* 5-12 months \[1 year of age\] (N=300, of which: 5-6 months =100, 7-9 months =100, 10-12 months =100) * 13-36 months \[2, 3 years of age\] (N=400, of which: 13-24 months =200, 25-36 months =200) * 37-72 months \[4, 5, 6 years of age\] (N=300, of which 37-48 months =100, 49-60 months =100, 61-72 months =100)

Research tools and methods:

The survey will be carried out by field interviewers who will have received prior training in nutrition interviewing and anthropometric measurements. The training will be provided by a dietician and an anthropologist.

The parent (legal guardian), together with the interviewer will fill in a survey questionnaire with the inclusion of a food frequency questionnaire (FFQ) computer-assisted personal interview (CAPI), aimed at a qualitative assessment of the diet, including the identification of eating patterns. The survey will also collect socio-demographic characteristics/family/environmental conditions.

A quantitative assessment of diet, including the nutritional value of diets will be assessed by recording food intake from 3 consecutive days, including one weekend day \[a diet diary completed by the parent/legal guardian themselves\] in an online format. The data will be entered into the Diet 6 program where the nutritional value of the diets from the indivi

• Other nutrients intake [Срок оценки: three-day consumption]
• Population risk of nutritional deficiencies [Срок оценки: the last 14 days of the FFQ]
• Nutritional status [Срок оценки: At the time of the dietary interview]