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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

Nutritional Study in Spanish Pediatric Population

Clinicaltrials.gov identifier NCT03941392

Recruitment Status Completed

First Posted May 8, 2019

Last update posted February 5, 2020

Study Description

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:Sedentary Lifestyle
    Food Habits
    Nutritional Status
    Diet, Food and Nutrition
    Child, Only
    Metabolic Diseases
    Child Development
    Diet Habit
    Healthy Diet
    Feeding Behavior
    Health Behavior
  • Intervention/Treatment:
  • Phase: N/A
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 Design
  • 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 2018
  • Actual Primary Completion Date: February 2019
  • Actual Study Completion Date: August 2019
Outcome Measures
  • 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.
Eligibility Criteria
  • Ages Eligible for Study: 1 to 9 Year (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.

Contacts and Locations
Contacts
Locations

Spain
Fundación Iberoamericana de Nutrición
Granada

Sponsors and Collaborators

Fundacion Iberoamericana de Nutricion

Universidad de Granada

Fundación Española de la Nutrición

CEU San Pablo University

Lactalis

More Information
  • 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: February 5, 2020
  • Last Verified: February 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • 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: Pediatric age
    Physical activity
    Dairy products
    Dairy consumption
    Children
    Sedentary habits
    Diet quality
    Nutrition
  • Additional relevant MeSH terms: Metabolic Diseases