NCT05380674

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
305

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 19, 2022

Completed
Last Updated

May 19, 2022

Status Verified

May 1, 2022

Enrollment Period

5 months

First QC Date

May 10, 2022

Last Update Submit

May 13, 2022

Conditions

Keywords

Health-related quality of lifephysical stateadherence to the Mediterranean dietschoolchildren

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

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

Interventions

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

quality of life

Eligibility Criteria

Age8 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

school children aged 8 to 16.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Católica de Ávila

Ávila, 05005, Spain

Location

Related Publications (7)

  • 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.

    PMID: 19918964BACKGROUND
  • 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.

    PMID: 29121640BACKGROUND
  • 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.

    PMID: 29403321BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 10, 2022

First Posted

May 19, 2022

Study Start

January 12, 2021

Primary Completion

June 1, 2021

Study Completion

May 1, 2022

Last Updated

May 19, 2022

Record last verified: 2022-05

Locations