Clinical trial NCT03941392: Nutritional Study in Spanish Pediatric Population
Official title: Nutritional Study in Spanish Pediatric Population (EsNuPI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Child, Only
Metabolic Diseases
Child Development
Diet Habit
Healthy Diet
Feeding Behavior
Health Behavior
Sedentary Lifestyle
Food Habits
Nutritional Status
Diet, Food and Nutrition
Keywords: Nutrition
Pediatric age
Physical activity
Dairy products
Dairy consumption
Sedentary habits
Diet quality
Children
Lead sponsor: Fundacion Iberoamericana de Nutricion
Sponsor class: OTHER
Collaborators: name: Universidad de Granada
name: Fundación Española de la Nutrición
name: CEU San Pablo University
name: Lactalis
First posted: 2019-05-08
Enrollment: 1500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Apparently healthy children between 1 to 9 years who live in an urban area with more than 50 000 inhabitants in Spain and that answer all the study recalls

Brief summary: This study investigates the aspects related to the intake of food and nutrients, physical activity and sedentary behavior of Spanish children from 1 to 9 years. Furthermore, the investigators will know if the consumption of dairy products is associated with a better dietary pattern.

Hypothesis: The habitual consumption of dairy products as part of a regular diet is associated with a better dietary pattern and a higher global diet quality.

Detailed description: A prospective cross-sectional observational study in 1500 Spanish children (1 to 9 years) in urban areas \>50,0000 inhabitants, distributed in eight regions (according to Nielsen Spanish areas) aiming to evaluate the food habits, dietary patterns, and nutrient intake, as well as physical activity behaviors.

Eligibility criteria: Inclusion Criteria:

* Healthy participants between 1 and 9 years old without diseases carrying changes in the dietary patterns.
* Those following dietary advice such as for prevention of non-communicable chronic diseases

Exclusion Criteria:

* Children with any disease that cause changes in the dietary pattern and with any dietary restriction.
* Children suffering a metabolic disease such as hyperthyroidism or hypothyroidism.
* Children diagnosed with allergy and/or food intolerance like dairy allergy, milk allergy, lactose intolerance or cows milk protein allergy.
* Children with any chronic disease that causes changes in the dietary pattern
* Children who live in an institution (colleges, nursing homes, hospitals, host Institutions, etc )
* Children with a transitory pathology (flu, gastroenteritis, chicken pox, etc) at the time of the fieldwork.
* Children following a therapeutic diet due to recent surgery or any other medical prescription.
* Children related to Lactalis or Madison MK employees.
* Children whose parents or caregivers did not provide a signed consent form for their participation or not completed any study phase.

Primary outcomes:
measure: Dietary habits
timeFrame: 10 months
measure: Food
timeFrame: 10 months
measure: Beverages
timeFrame: 10 months
measure: Energy, macro and micronutrient composition of the diet
timeFrame: 10 months
measure: Active and sedentary habits
timeFrame: 10 months
measure: Milk and dairy products consumption
timeFrame: 10 months
measure: Dietary quality index for children "KidMed"
timeFrame: 10 months
Secondary outcomes:
measure: Growth and BMI
timeFrame: 1 year
measure: Goldberg & Black cut-off for Energy Intake: Plausibility of the reported energy intake
timeFrame: 1 year
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Fundación Iberoamericana de Nutrición
Study officials:
References: