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Completed

NCT Number: NCT03941392

Nutritional Study in Spanish Pediatric Population

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.

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Key information

Conditions

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

Age range

1 year–9 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fundación Iberoamericana de Nutrición

Granada, 18016, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Fundacion Iberoamericana de Nutricion

Other

Collaborators

  • CEU San Pablo University
  • Fundación Española de la Nutrición
  • Lactalis
  • Universidad de Granada

Registry information

Official study title

Nutritional Study in Spanish Pediatric Population (EsNuPI)

Acronym: EsNuPI

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 8, 2019
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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