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

Quality of Life Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05380674
• Other study ID #: 10/05/2022
• Status: Completed
• Start date: January 12, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: May 2022
• Source: Universidad Católica de Ávila
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 305
• Est. completion date: May 1, 2022
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Physical Inactivity
• Quality of Life

Intervention

Behavioral:
• The short questionnaire of healthy habits
collects sociodemographic data, weight, height, and physical activity, self-reported.

Locations

Country	Name	City	State
Spain	Universidad Católica de Ávila	Ávila

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Católica de Ávila

Country where clinical trial is conducted

Spain, 

References & Publications (7)

Evaristo S, Moreira C, Lopes L, Oliveira A, Abreu S, Agostinis-Sobrinho C, Oliveira-Santos J, Póvoas S, Santos R, Mota J. Muscular fitness and cardiorespiratory fitness are associated with health-related quality of life: Results from labmed physical activ — View Citation

Freedson P, Bowles HR, Troiano R, Haskell W. Assessment of physical activity using wearable monitors: recommendations for monitor calibration and use in the field. Med Sci Sports Exerc. 2012 Jan;44(1 Suppl 1):S1-4. doi: 10.1249/MSS.0b013e3182399b7e. — View Citation

Knox E, Muros JJ. Association of lifestyle behaviours with self-esteem through health-related quality of life in Spanish adolescents. Eur J Pediatr. 2017 May;176(5):621-628. doi: 10.1007/s00431-017-2886-z. Epub 2017 Mar 6. — View Citation

Muros JJ, Salvador Pérez F, Zurita Ortega F, Gámez Sánchez VM, Knox E. The association between healthy lifestyle behaviors and health-related quality of life among adolescents. J Pediatr (Rio J). 2017 Jul - Aug;93(4):406-412. doi: 10.1016/j.jped.2016.10.0 — View Citation

Paxton RJ, Jones LW, Rosoff PM, Bonner M, Ater JL, Demark-Wahnefried W. Associations between leisure-time physical activity and health-related quality of life among adolescent and adult survivors of childhood cancers. Psychooncology. 2010 Sep;19(9):997-1003. doi: 10.1002/pon.1654. — View Citation

Quante M, Kaplan ER, Cailler M, Rueschman M, Wang R, Weng J, Taveras EM, Redline S. Actigraphy-based sleep estimation in adolescents and adults: a comparison with polysomnography using two scoring algorithms. Nat Sci Sleep. 2018 Jan 18;10:13-20. doi: 10.2147/NSS.S151085. eCollection 2018. — View Citation

Wu XY, Han LH, Zhang JH, Luo S, Hu JW, Sun K. The influence of physical activity, sedentary behavior on health-related quality of life among the general population of children and adolescents: A systematic review. PLoS One. 2017 Nov 9;12(11):e0187668. doi: 10.1371/journal.pone.0187668. eCollection 2017. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health-related quality of life	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
Primary	Eating habits	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