Quality of Diet in Preschool Population

January 4, 2022 updated by: Universidad Francisco de Vitoria

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

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Madrid
      • Pozuelo de Alarcón, Madrid, Spain, 28224
        • David Varillas Delgado

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 5 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Experimental

The experimental group conducted 10 weekly sessions, with an approximate duration of 45 minutes per session, which consisted of the presentation of food education content while conducting an orchard with seasonal vegetables. Simple recipes were also described in which these vegetables were included to be made at home, along with information on children's books that dealt with the topic of food and were available in the public library.

All children in the experimental groups were given written instructions so that they could perform at their home, together with their parents, the manipulative activities suggested each week. All these contents were common for all the participants in the study. Session material was renewed weekly.

The intervention consisted of the presentation of food education content while conducting an orchard with seasonal vegetables
NO_INTERVENTION: Control
The control group received the usual training corresponding to the contents of the "human body" module that is currently taught in each center.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of KIDMED questionnaire
Time Frame: During the procedure; baseline, 1 year and 2 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Weight
Time Frame: During the procedure; baseline, 1 year and 2 years
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
Educational level of parents
Time Frame: Baseline
A survey will assess the level of education of parents; primary, secondary, university or without education, expressed in %.
Baseline
Employment status of parents
Time Frame: Baseline
The parents' purchasing level will be evaluated in percentages (%); low, medium and high employement status.
Baseline
Change of Height
Time Frame: During the procedure; baseline, 1 year and 2 years
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
Change of BMI (body mass index)
Time Frame: During the procedure; baseline, 1 year and 2 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2017

Primary Completion (ACTUAL)

April 1, 2017

Study Completion (ACTUAL)

September 1, 2020

Study Registration Dates

First Submitted

February 29, 2020

First Submitted That Met QC Criteria

March 5, 2020

First Posted (ACTUAL)

March 10, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 5, 2022

Last Update Submitted That Met QC Criteria

January 4, 2022

Last Verified

August 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Feeding and Eating Disorders of Childhood

Clinical Trials on Education food

Subscribe