Health-related Quality of Life in a Cohort of Spanish Schoolchildren.

May 13, 2022 updated by: JORGE VELAZQUEZ SAORNIL, Universidad Católica de Ávila

Health-related Quality of Life in a Cohort of Spanish Schoolchildren and Its Association With the Physical State and Adherence to the Mediterranean Diet.

Background: Health-related quality of life (HRQoL) allows knowing the subject's feelings in terms of distress and well-being, as well as her perception of her current and future health.

Objective: Evaluate the associations between health-related quality of life, physical state, and adherence to the Mediterranean diet in a cohort of Spanish children and adolescents. Methods: A cross-sectional study was carried out in a cohort of 305 (47.2% women) children and adolescents aged between 8 and 16 years, in the Primary and Secondary Schools of the province of Ávila (Spain). For the analysis of the different variables, the subjects were classified according to their quality of life in three groups from highest to lowest (Group 1 > Group 2 > Group 3).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

305

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Ávila, Spain, 05005
        • Universidad Católica de Ávila

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 16 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

school children aged 8 to 16.

Description

Inclusion Criteria:

  • school children aged 8 to 16
  • present the informed consent signed by the parents or legal guardians

Exclusion Criteria:

  • serious illness that may influence the nutritional or functional status of the child, mental limitation of the parents and / or children that may hinder the completion of the questionnaire.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
quality of life
The short questionnaire of healthy habits for adults of the PASOS (Physical Activity, Sedentarism and Obesity in Spanish Youth) study was used, which collects sociodemographic data, weight, height, and physical activity, self-reported.
Behavioral: The short questionnaire of healthy habits
collects sociodemographic data, weight, height, and physical activity, self-reported.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related quality of life
Time Frame: 3 months
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, mild problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate their health status by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number expressing the level selected for that dimension. The digits of the five dimensions can be combined into a 5-digit number describing the patient's health status.
3 months
Eating habits
Time Frame: 3 months

the total index ranges from 0 to 12, and the final score is classified into three levels:

>8, ideal Mediterranean diet.

4-7, improvements needed to adjust the intake to the patterns of the Mediterranean diet.

≤3, very poor dietary quality. and adolescence on which the KIDMED index.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Católica de Ávila

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2021

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

May 1, 2022

Study Registration Dates

First Submitted

May 10, 2022

First Submitted That Met QC Criteria

May 13, 2022

First Posted (Actual)

May 19, 2022

Study Record Updates

Last Update Posted (Actual)

May 19, 2022

Last Update Submitted That Met QC Criteria

May 13, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 10/05/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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