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Completed

NCT Number: NCT05380674

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

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).

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Key information

Age range

8 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universidad Católica de Ávila

Ávila, 05005, Spain

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

The short questionnaire of healthy habits

Behavioral

collects sociodemographic data, weight, height, and physical activity, self-reported.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Universidad Católica de Ávila

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
May 19, 2022
Registry last updated
May 19, 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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