Quality of LifeNCT05380674
Health-related Quality of Life in a Cohort of Spanish Schoolchildren.
An observational study of Quality of Life and Physical Inactivity, run by Universidad Católica de Ávila at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 8 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Physical Inactivity
- What is being tested?
- The short questionnaire of healthy habits
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 305 participants
- Where
- 1 siteSpain
- Study dates
- 12 Jan 2021to 1 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: school children aged 8 to 16.
Who may be able to join
- school children aged 8 to 16
- present the informed consent signed by the parents or legal guardians
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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).
- Conditions
- Quality of Life, Physical Inactivity
- Being tested
- The short questionnaire of healthy habits
- Keywords
- Health-related quality of life, physical state, adherence to the Mediterranean diet, schoolchildren
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The short questionnaire of healthy habitsBehavioural
collects sociodemographic data, weight, height, and physical activity, self-reported.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: The short questionnaire of healthy habits |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start12 Jan 2021
- Primary completion1 Jun 2021
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica de Ávila
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JORGE VELAZQUEZ SAORNIL, Universidad Católica de Ávila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380674
- Sponsor's protocol ID
- 10/05/2022
- Status last verified
- May 2022
- First submitted
- 10 May 2022
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 19918964Wu 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.
PubMed 29121640Quante 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.
PubMed 29403321Evaristo 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.
PubMed 30740134Muros 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.
PubMed 28130968Knox 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.
PubMed 28265762Freedson 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.
PubMed 22157769
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05380674
- Acronym / sponsor ID
- 10/05/2022
- Conditions
- Quality of Life, Physical Inactivity
- Keywords
- Health-related quality of life, physical state, adherence to the Mediterranean diet, schoolchildren
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- Universidad Católica de ÁvilaUniversity, hospital or other
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| quality of life | – | Behavioral: The short questionnaire of healthy habitsThe 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. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- school children aged 8 to 16.
Key inclusion criteria (2 listed)
- school children aged 8 to 16
- present the informed consent signed by the parents or legal guardians
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The short questionnaire of healthy habitscollects sociodemographic data, weight, height, and physical activity, self-reported. | Behavioural | quality of life |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Background: PubMed 19918964Paxton 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.
- Background: PubMed 29121640Wu 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.
- Background: PubMed 29403321Quante 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.
- Results publication: PubMed 30740134Evaristo 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.
- Results publication: PubMed 28130968Muros 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.
- Results publication: PubMed 28265762Knox 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.
- Results publication: PubMed 22157769Freedson 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.
- Individual participant dataSharing planned: Undecided
Related trials for Quality of Life
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Study of a Support Program for Quality of Life in Chinese Cancer Patients and Survivors
Cancer, Survivorship
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life and Physical Inactivity, run by Universidad Católica de Ávila at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05380674, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.