Nutritional Study in Spanish Pediatric Population (EsNuPI)

Nutritional Study in Spanish Pediatric Population (EsNuPI)

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Diseases; Sedentary Lifestyle; Nutritional Status; Child Development; Health Behavior; Child, Only; Feeding Behavior; Diet Habit; Healthy Diet; Food Habits; Diet, Food and Nutrition

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.

• Study Type: Observational
• Enrollment (Actual): 1500

Contacts and Locations

Study Locations

• Spain
  • Granada, Spain, 18016
    • Fundación Iberoamericana de Nutrición

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 9 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Healthy children between 1 and 9 years old; A sample of 1500 apparently healthy children between 1 to 9 years old from urban areas from different regions of Spain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary habits	Dietary diversity and variety determinated by using a FFQ from last year of consumption, the FFQ consisted of 150 food items commonly used in the local Spanish cuisine. The FFQ asked about consumption of foods and beverages in portions per day, week or month	10 months
Food	Food groups will be obtained from the FFQ of last year's consumption, the FFQ consisted of 150 food items commonly used in the local Spanish cuisine. The FFQ asked about consumption of foods and beverages in portions per day, week or month. The food based dietary guidelines from Spain will be used to determine the number of portions consumed per food group.	10 months
Beverages	Beverage groups will be obtained from the FFQ of last year's consumption, the FFQ consisted of 150 food items commonly used in the local Spanish cuisine. The FFQ asked about consumption of foods and beverages in portions per day, week or month. The food based dietary guidelines from Spain will be used to determine the number of portions consumed per beverage group.	10 months
Energy, macro and micronutrient composition of the diet	Energy, macro and micronutrient composition of the diet determined by 2 24-h recalls	10 months
Active and sedentary habits	Active and sedentary habits were measured with the 1-week activity recall validated in children	10 months
Milk and dairy products consumption	Evaluate the different types of milk that children drink in 24 h, twice through 24 h dietary	10 months
Dietary quality index for children "KidMed"	Evaluate the quality of the diet through this quality index for the specific age group	10 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Growth and BMI	Determined by reported age, weight (kg), and height (cm)	1 year
Goldberg & Black cut-off for Energy Intake: Plausibility of the reported energy intake	Measured by the relation between the reported energy intake and the estimated energy expenditure. The cut-off points are determined by the information reported by the population itself.	1 year

Collaborators and Investigators

• Sponsor: Fundacion Iberoamericana de Nutricion
• Collaborators: CEU San Pablo University; Universidad de Granada; Lactalis; Fundación Española de la Nutrición

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 2, 2018
• Primary Completion (ACTUAL): February 28, 2019
• Study Completion (ACTUAL): August 31, 2019

Study Registration Dates

• First Submitted: April 22, 2019
• First Submitted That Met QC Criteria: May 6, 2019
• First Posted (ACTUAL): May 8, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 3, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Children; Nutrition; Physical activity; Diet quality; Dairy consumption; Dairy products; Pediatric age; Sedentary habits
• Additional Relevant MeSH Terms: Metabolic Diseases
• Other Study ID Numbers: FF01/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No