NCT04301180

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

February 29, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 10, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

January 5, 2022

Status Verified

August 1, 2021

Enrollment Period

Same day

First QC Date

February 29, 2020

Last Update Submit

January 4, 2022

Conditions

Keywords

Nutritional StatusChild Nutrition SciencesNutrition TherapyNutrition AssessmentDiet, Food, and Nutrition

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Change of Weight

    During the procedure; baseline, 1 year and 2 years

  • Educational level of parents

    Baseline

  • Employment status of parents

    Baseline

  • Change of Height

    During the procedure; baseline, 1 year and 2 years

  • Change of BMI (body mass index)

    During the procedure; baseline, 1 year and 2 years

Study Arms (2)

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.

Device: Education food

Control

NO INTERVENTION

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

Interventions

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

Experimental

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age between 3 and 5 years
  • Oral comprehension of Spanish.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

David Varillas Delgado

Pozuelo de Alarcón, Madrid, 28224, Spain

Location

MeSH Terms

Conditions

Feeding and Eating Disorders of Childhood

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 29, 2020

First Posted

March 10, 2020

Study Start

April 1, 2017

Primary Completion

April 1, 2017

Study Completion

September 1, 2020

Last Updated

January 5, 2022

Record last verified: 2021-08

Locations