Quality of Diet in Preschool Population

Feeding and Eating Disorders of Childhood Clinical Trial

Official title:

Effectiveness of a Multicompetent Intervention on the Quality of the Diet in the Preschool Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04301180
• Other study ID #: CEIC 2016/013
• Status: Completed
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: September 1, 2020

Study information

• Verified date: August 2021
• Source: Universidad Francisco de Vitoria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Childhood obesity is a problem of high prevalence and repercussions in adulthood. It is mostly due to inadequate life habits, modifiable through preventive strategies. The objective was to evaluate in the medium term the effectiveness of an intervention on adherence to the Mediterranean diet pattern in preschoolers.

Method: Community trial with two groups, in children between 3-5 years. The experimental group conducted a school garden and the usual contents on human body and health were taught in the control. Two schools were selected by cluster sampling, whose first unit of randomization were the educational areas followed by schools. The adaptation to the Mediterranean diet pattern was evaluated using the KIDMED questionnaire and weight, height, BMI and sociodemographic variables were controlled.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: September 1, 2020
• Est. primary completion date: April 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

Inclusion Criteria:

• Age between 3 and 5 years

• Oral comprehension of Spanish.

Exclusion Criteria:

• Existence of language barriers in parents defined as not understanding spoken or written Spanish.

• Treatment with glucocorticoids.

• Having chronic diseases that could interfere with somatometry.

Related Conditions & MeSH terms

• Feeding and Eating Disorders
• Feeding and Eating Disorders of Childhood

Intervention

Device:
• Education food
The intervention consisted of the presentation of food education content while conducting an orchard with seasonal vegetables

Locations

Country	Name	City	State
Spain	David Varillas Delgado	Pozuelo de Alarcón	Madrid

Sponsors (6)

Lead Sponsor	Collaborator
Universidad Francisco de Vitoria	David Varillas Delgado, Juana Robledo-Martín, María Cristina Martincrespo-Blanco, María Gema Cid-Expósito, Saray Blanco-Abril

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of KIDMED questionnaire	Mediterranean diet adherence assessment questionnaire, 16 items, scored of 1 point per item, minimun 0 points (worse) to 16 points (better).	During the procedure; baseline, 1 year and 2 years
Secondary	Change of Weight	Changes of Weight in kilograms (Kg), were collected in children using approved scale at baseline, al 1 year and 2 years.	During the procedure; baseline, 1 year and 2 years
Secondary	Educational level of parents	A survey will assess the level of education of parents; primary, secondary, university or without education, expressed in %.	Baseline
Secondary	Employment status of parents	The parents' purchasing level will be evaluated in percentages (%); low, medium and high employement status.	Baseline
Secondary	Change of Height	Changes of Height in meters, were collected in children using approved scale at baseline, al 1 year and 2 years.	During the procedure; baseline, 1 year and 2 years
Secondary	Change of BMI (body mass index)	Change of weight and height outcomes will be combined to report BMI in kg/m^2, upper 20 is considered obesity.	During the procedure; baseline, 1 year and 2 years