Nutritional Study in Spanish Pediatric Population

Health Behavior Clinical Trial

— EsNuPI  

Official title:

Nutritional Study in Spanish Pediatric Population (EsNuPI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03941392
• Other study ID #: FF01/2019
• Status: Completed
• Start date: October 2, 2018
• Est. completion date: August 31, 2019

Study information

• Verified date: February 2020
• Source: Fundacion Iberoamericana de Nutricion
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: August 31, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 9 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Spain	Fundación Iberoamericana de Nutrición	Granada

Sponsors (5)

Lead Sponsor	Collaborator
Fundacion Iberoamericana de Nutricion	CEU San Pablo University, Fundación Española de la Nutrición, Lactalis, Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Energy, macro and micronutrient composition of the diet	Energy, macro and micronutrient composition of the diet determined by 2 24-h recalls	10 months
Primary	Active and sedentary habits	Active and sedentary habits were measured with the 1-week activity recall validated in children	10 months
Primary	Milk and dairy products consumption	Evaluate the different types of milk that children drink in 24 h, twice through 24 h dietary	10 months
Primary	Dietary quality index for children "KidMed"	Evaluate the quality of the diet through this quality index for the specific age group	10 months
Secondary	Growth and BMI	Determined by reported age, weight (kg), and height (cm)	1 year
Secondary	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