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Quality of Diet in Preschool Population

Primary Purpose

Feeding and Eating Disorders of Childhood

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Education food
Sponsored by
Universidad Francisco de Vitoria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Feeding and Eating Disorders of Childhood focused on measuring Nutritional Status, Child Nutrition Sciences, Nutrition Therapy, Nutrition Assessment, Diet, Food, and Nutrition

Eligibility Criteria

3 Years - 5 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • David Varillas Delgado

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental

Control

Arm Description

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 control group received the usual training corresponding to the contents of the "human body" module that is currently taught in each center.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Change of Weight
Changes of Weight in kilograms (Kg), were collected in children using approved scale at baseline, al 1 year and 2 years.
Educational level of parents
A survey will assess the level of education of parents; primary, secondary, university or without education, expressed in %.
Employment status of parents
The parents' purchasing level will be evaluated in percentages (%); low, medium and high employement status.
Change of Height
Changes of Height in meters, were collected in children using approved scale at baseline, al 1 year and 2 years.
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.

Full Information

First Posted
February 29, 2020
Last Updated
January 4, 2022
Sponsor
Universidad Francisco de Vitoria
Collaborators
David Varillas Delgado, María Cristina Martincrespo-Blanco, Saray Blanco-Abril, María Gema Cid-Expósito, Juana Robledo-Martín
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1. Study Identification

Unique Protocol Identification Number
NCT04301180
Brief Title
Quality of Diet in Preschool Population
Official Title
Effectiveness of a Multicompetent Intervention on the Quality of the Diet in the Preschool Population
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
April 1, 2017 (Actual)
Study Completion Date
September 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Francisco de Vitoria
Collaborators
David Varillas Delgado, María Cristina Martincrespo-Blanco, Saray Blanco-Abril, María Gema Cid-Expósito, Juana Robledo-Martín

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Feeding and Eating Disorders of Childhood
Keywords
Nutritional Status, Child Nutrition Sciences, Nutrition Therapy, Nutrition Assessment, Diet, Food, and Nutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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 from children's books that dealt with the topic of food and were available in the public library. The control group received the usual training corresponding to the contents of the "human body" module that is currently taught in each center. 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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group received the usual training corresponding to the contents of the "human body" module that is currently taught in each center.
Intervention Type
Device
Intervention Name(s)
Education food
Intervention Description
The intervention consisted of the presentation of food education content while conducting an orchard with seasonal vegetables
Primary Outcome Measure Information:
Title
Change of KIDMED questionnaire
Description
Mediterranean diet adherence assessment questionnaire, 16 items, scored of 1 point per item, minimun 0 points (worse) to 16 points (better).
Time Frame
During the procedure; baseline, 1 year and 2 years
Secondary Outcome Measure Information:
Title
Change of Weight
Description
Changes of Weight in kilograms (Kg), were collected in children using approved scale at baseline, al 1 year and 2 years.
Time Frame
During the procedure; baseline, 1 year and 2 years
Title
Educational level of parents
Description
A survey will assess the level of education of parents; primary, secondary, university or without education, expressed in %.
Time Frame
Baseline
Title
Employment status of parents
Description
The parents' purchasing level will be evaluated in percentages (%); low, medium and high employement status.
Time Frame
Baseline
Title
Change of Height
Description
Changes of Height in meters, were collected in children using approved scale at baseline, al 1 year and 2 years.
Time Frame
During the procedure; baseline, 1 year and 2 years
Title
Change of BMI (body mass index)
Description
Change of weight and height outcomes will be combined to report BMI in kg/m^2, upper 20 is considered obesity.
Time Frame
During the procedure; baseline, 1 year and 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
David Varillas Delgado
City
Pozuelo de Alarcón
State/Province
Madrid
ZIP/Postal Code
28224
Country
Spain

12. IPD Sharing Statement

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Quality of Diet in Preschool Population

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