Quality of Diet in Preschool Population

NCT ID: NCT04301180

Last Updated: 2022-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2020-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Feeding and Eating Disorders of Childhood

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Education food

Intervention Type DEVICE

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

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Education food

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

David Varillas Delgado

UNKNOWN

Sponsor Role collaborator

María Cristina Martincrespo-Blanco

UNKNOWN

Sponsor Role collaborator

Saray Blanco-Abril

UNKNOWN

Sponsor Role collaborator

María Gema Cid-Expósito

UNKNOWN

Sponsor Role collaborator

Juana Robledo-Martín

UNKNOWN

Sponsor Role collaborator

Universidad Francisco de Vitoria

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

David Varillas Delgado

Pozuelo de Alarcón, Madrid, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CEIC 2016/013

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Protocol to Promote Critical Consumption (PCC)
NCT06996847 NOT_YET_RECRUITING NA
Management of Childhood Obesity
NCT05966259 COMPLETED NA
Childhood Overweight
NCT00916318 UNKNOWN NA