Nutritional Study in Spanish Pediatric Population

NCT03941392 | Completed DMC

• 1 other identifier: FF01/2019
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Nutrition; Pediatric age; Physical activity; Dairy products; Dairy consumption; Sedentary habits; Diet quality; Children

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (2)

• Growth and BMI

  1 year

• Goldberg & Black cut-off for Energy Intake: Plausibility of the reported energy intake

  1 year

Study Arms (1)

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.

Eligibility Criteria

• Age: 1 Year - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion Iberoamericana de Nutricion: lead
• Universidad de Granada: collaborator
• Fundación Española de la Nutrición: collaborator
• CEU San Pablo University: collaborator
• Lactalis: collaborator

Study Sites (1)

Fundación Iberoamericana de Nutrición

Granada, 18016, Spain

Location

MeSH Terms

Conditions

Metabolic Diseases; Feeding Behavior; Health Behavior; Sedentary Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Behavior, Animal; Behavior

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: May 8, 2019
• Study Start: October 2, 2018
• Primary Completion: February 28, 2019
• Study Completion: August 31, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)