- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04301180
Quality of Diet in Preschool Population
Effectiveness of a Multicompetent Intervention on the Quality of the Diet in the 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Madrid
-
Pozuelo de Alarcón, Madrid, Spain, 28224
- David Varillas Delgado
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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. |
The intervention consisted of the presentation of food education content while conducting an orchard with seasonal vegetables
|
NO_INTERVENTION: Control
The control group received the usual training corresponding to the contents of the "human body" module that is currently taught in each center.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
During the procedure; baseline, 1 year and 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
During the procedure; baseline, 1 year and 2 years
|
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 %.
|
Baseline
|
Employment status of parents
Time Frame: Baseline
|
The parents' purchasing level will be evaluated in percentages (%); low, medium and high employement status.
|
Baseline
|
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.
|
During the procedure; baseline, 1 year and 2 years
|
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.
|
During the procedure; baseline, 1 year and 2 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEIC 2016/013
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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