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OpenTrials
Completed

NCT Number: NCT04301180

Quality of Diet in 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.

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Key information

Conditions

Feeding and Eating Disorders of Childhood Feeding and Eating Disorders Mental Disorders

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

David Varillas Delgado

Pozuelo de Alarcón, Madrid, 28224, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Education food

Device

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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 %.

  3. Employment status of parents

    Time frame: Baseline

    The parents' purchasing level will be evaluated in percentages (%); low, medium and high employement status.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Universidad Francisco de Vitoria

Other

Collaborators

  • David Varillas Delgado
  • Juana Robledo-Martín
  • María Cristina Martincrespo-Blanco
  • María Gema Cid-Expósito
  • Saray Blanco-Abril

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2020
First posted
Mar 10, 2020
Registry last updated
Jan 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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