Nutritional Study in Spanish Pediatric Population

Completed

• Conditions: Metabolic Diseases; Child Development; Feeding Behavior; Diet Habit; Health Behavior; Diet, Food and Nutrition; Child, Only; Food Habits; Sedentary Lifestyle; Healthy Diet

• Registration Number: NCT03941392
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-10-02
• Primary Completion: 2019-02-28
• Study First Submitted: 2019-04-22
• Study First Submitted QC: 2019-05-06
• Study First Posted: 2019-05-08
• Study Completion: 2019-08-31
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-03
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Food	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.
Active and sedentary habits	10 months	Active and sedentary habits were measured with the 1-week activity recall validated in children
Milk and dairy products consumption	10 months	Evaluate the different types of milk that children drink in 24 h, twice through 24 h dietary
Dietary quality index for children "KidMed"	10 months	Evaluate the quality of the diet through this quality index for the specific age group
Dietary habits	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
Beverages	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.
Energy, macro and micronutrient composition of the diet	10 months	Energy, macro and micronutrient composition of the diet determined by 2 24-h recalls

Secondary Outcome Measures

Name	Time	Method
Growth and BMI	1 year	Determined by reported age, weight (kg), and height (cm)
Goldberg & Black cut-off for Energy Intake: Plausibility of the reported energy intake	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.

Trial Locations

Locations (1)

Fundación Iberoamericana de Nutrición; 🇪🇸 Granada, Spain