Clinical trial NCT05380674: Health-related Quality of Life in a Cohort of Spanish Schoolchildren.
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Physical Inactivity
Keywords: Health-related quality of life
physical state
adherence to the Mediterranean diet
schoolchildren
Lead sponsor: Universidad Católica de Ávila
Sponsor class: OTHER
First posted: 2022-05-19
Enrollment: 305
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: school children aged 8 to 16.

Brief summary: Background: Health-related quality of life (HRQoL) allows knowing the subject\&#39;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 \&gt; Group 2 \&gt; Group 3).


Eligibility criteria: 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.

Primary outcomes:
measure: Health-related quality of life
timeFrame: 3 months
measure: Eating habits
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ávila
country: Spain
facility: Universidad Católica de Ávila
Study officials:
References:
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.
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.
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.
citation: Evaristo S, Moreira C, Lopes L, Oliveira A, Abreu S, Agostinis-Sobrinho C, Oliveira-Santos J, Povoas S, Santos R, Mota J. Muscular fitness and cardiorespiratory fitness are associated with health-related quality of life: Results from labmed physical activity study. J Exerc Sci Fit. 2019 Jan 20;17(2):55-61. doi: 10.1016/j.jesf.2019.01.002. Epub 2019 Jan 8.
citation: Muros JJ, Salvador Perez F, Zurita Ortega F, Gamez Sanchez 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.2016.10.005. Epub 2017 Jan 25.
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.
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.