Clinical trial NCT04301180: 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
Overall status: COMPLETED
Phase: NA
Conditions: Feeding and Eating Disorders of Childhood
Keywords: Nutritional Status
Child Nutrition Sciences
Nutrition Therapy
Nutrition Assessment
Diet, Food, and Nutrition
Lead sponsor: Universidad Francisco de Vitoria
Sponsor class: OTHER
Collaborators: name: David Varillas Delgado
name: María Cristina Martincrespo-Blanco
name: Saray Blanco-Abril
name: María Gema Cid-Expósito
name: Juana Robledo-Martín
First posted: 2020-03-10
Enrollment: 130
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change of KIDMED questionnaire
timeFrame: During the procedure; baseline, 1 year and 2 years
Secondary outcomes:
measure: Change of Weight
timeFrame: During the procedure; baseline, 1 year and 2 years
measure: Educational level of parents
timeFrame: Baseline
measure: Employment status of parents
timeFrame: Baseline
measure: Change of Height
timeFrame: During the procedure; baseline, 1 year and 2 years
measure: Change of BMI (body mass index)
timeFrame: During the procedure; baseline, 1 year and 2 years
Other outcomes:
Locations:
city: Pozuelo de Alarcón
country: Spain
facility: David Varillas Delgado
state: Madrid
Study officials:
References: