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Nutritional Study in Spanish Pediatric Population (EsNuPI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03941392
Recruitment Status : Active, not recruiting
First Posted : May 8, 2019
Last Update Posted : May 8, 2019
Sponsor:
Collaborators:
Universidad de Granada
Fundación Española de la Nutrición
CEU San Pablo University
Lactalis
Information provided by (Responsible Party):
Fundacion Iberoamericana de Nutricion

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.


Condition or disease
Child, Only Metabolic Diseases Child Development Diet Habit Healthy Diet Feeding Behavior Health Behavior Sedentary Lifestyle Food Habits Nutritional Status 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.

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Study Type : Observational
Actual Enrollment : 1500 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Nutritional Study in Spanish Pediatric Population (EsNuPI)
Actual Study Start Date : October 2, 2018
Actual Primary Completion Date : February 28, 2019
Estimated Study Completion Date : July 31, 2019

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.



Primary Outcome Measures :
  1. Dietary habits [ Time Frame: 10 months ]
    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

  2. Food [ Time Frame: 10 months ]
    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.

  3. Beverages [ Time Frame: 10 months ]
    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.

  4. Energy, macro and micronutrient composition of the diet [ Time Frame: 10 months ]
    Energy, macro and micronutrient composition of the diet determined by 2 24-h recalls

  5. Active and sedentary habits [ Time Frame: 10 months ]
    Active and sedentary habits were measured with the 1-week activity recall validated in children

  6. Milk and dairy products consumption [ Time Frame: 10 months ]
    Evaluate the different types of milk that children drink in 24 h, twice through 24 h dietary

  7. Dietary quality index for children "KidMed" [ Time Frame: 10 months ]
    Evaluate the quality of the diet through this quality index for the specific age group


Secondary Outcome Measures :
  1. Growth and BMI [ Time Frame: 1 year ]
    Determined by reported age, weight (kg), and height (cm)

  2. Goldberg & Black cut-off for Energy Intake: Plausibility of the reported energy intake [ Time Frame: 1 year ]
    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.



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Ages Eligible for Study:   1 Year to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03941392


Locations
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Spain
Fundación Iberoamericana de Nutrición
Granada, Spain, 18016
Sponsors and Collaborators
Fundacion Iberoamericana de Nutricion
Universidad de Granada
Fundación Española de la Nutrición
CEU San Pablo University
Lactalis

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Responsible Party: Fundacion Iberoamericana de Nutricion
ClinicalTrials.gov Identifier: NCT03941392     History of Changes
Other Study ID Numbers: FF01/2019
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fundacion Iberoamericana de Nutricion:
Nutrition
Pediatric age
Physical activity
Dairy products
Dairy consumption
Sedentary habits
Diet quality
Children

Additional relevant MeSH terms:
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Metabolic Diseases