Systematic Examination of Health Inequalities: Documentation, Patterns, and Determinants
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- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
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- Состояния в реестре: Non-communicable Diseases (NCD), Addiction to Opioids, Incarceration, Opioid-use Disorders. Базовые параметры: от 18 лет · Все.
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Официальное название
Assessment of Lifestyle Parameters and Biomarkers of Biochemistry and Physiology to Address Health Inequalities: An Exploratory Cohort Study
Обзор
The existence of social inequalities is a major global issue and a salient challenge for the European Union. During COVID-19 pandemic, health disparities became more evident. Indeed, the low-income residents in several European countries, including Greece, had limited access to the healthcare system for several reasons. In addition, vulnerable populations, with patients suffering from opioid use disorders and incarcerated individuals being among them, do not have the same chances regarding health services, compared to the general population. According to the World Health Organization, physical activity is a key non-pharmaceutical intervention for both prevention of chronic non-communicable diseases and address of social health inequalities. Thus, this study will focus on specific population groups of the Region of Thessaly, Greece, who have limited access to healthcare services. It aims, primarily, to the assessment of demographic characteristics (i.e., body mass index, alcohol consumption, smoking, educational level etc), which are fundamental parameters for the assessment of health inequalities. Secondly, quality of life, physical activity levels and biomarkers in the level of Biochemistry (i.e., blood oxidative stress and inflammation) and Physiology (i.e., cardiorespiratory fitness, body composition) will be collected a well. All data will be integrated into an interactive digital platform that will be accessible by any putative stakeholder in the area of health system or administration. Based on scientifically robust data and evidence-based findings, the research team of the project will draft recommendations and guidelines that will be communicated to all stakeholders. To that end, the problem of limited access to health system that the examined populations face, will be highlighted and targeted actions and policies are expected to be adopted by local (i.e., in the province of Thessaly) and national (i.e., Greek) authorities. In this respect, non-pharmaceutical interventions and guidelines will be proposed towards the trajectory of holistically approaching the issue of health inequalities.
Подробное описание
Background: Health is defined as a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity. The delectation of the highest attainable standard of health - and therefore quality of life - is a fundamental human right, regardless of race, religion, political opinion or socio-economic status. Thus, the key aspects of health definition according to WHO include multidimensionality (i.e., it covers the physical, mental, and social dimension), absence of illness (i.e., health is defined by positive well-being) and right to health (i.e., the attaining of the highest standard of health is a fundamental and universal right). Apart from the biological characteristics or individual choices, human health is also shaped to a significant extent by the social, economic and environmental conditions in which people are born, grow up, live, work and age. These conditions are referred to as social determinants of health and decisively influence morbidity, mortality and overall quality of life of populations. Health determinants can be distinguished into social and economic (i.e., income, educational level and occupational status), environmental (i.e., housing and working conditions, behavioral factors related to lifestyle) and biological factors (i.e., age, gender and heredity). The problem of health inequalities is a major issue worldwide and is inextricably linked to the aforementioned health determinants. Health inequalities have been extensively defined as health disparities, within and between countries, that are judged to be unfair, unjust, avoidable, and unnecessary (meaning: are neither inevitable nor unremediable) and that systematically burden populations rendered vulnerable by underlying social structures and political, economic, and legal institutions. Populations who suffer from health inequalities are, among others, the elderly and individuals with non-communicable diseases who reside in rural areas away from cities, as well as often socially marginalized populations, namely patients with opioid use disorders (OUDs) and incarcerated individuals. Indeed, the above-mentioned populations face limited access to health services due to poverty, low education, geographical isolation and lack of infrastructure, while factors such as social isolation, lack of insurance coverage and limited social structures enhance their vulnerability. In the biochemical level, patients with OUDs are characterized by impaired blood antioxidant mechanisms that highly influence their health. This is also the case for inmates in correctional facilities, since their nutrition is very poor in compounds like vitamins, which protect blood and tissues from elevated levels of oxidized substrates, hence they suffer from oxidative stress. As a result, they are vulnerable to diverse mental and other health issues. Among environmental factors, physical activity and dietary habits significantly affect the occurrence of chronic diseases and the overall health status of populations, therefore they could be considered as interventions towards tackling the vast public health problem of health inequalities. According to OECD, approximately 40% of adults do not perform sufficient physical activity, a fact that increases the risk of developing cardiovascular diseases and other chronic pathologies. The interaction of physical activity with the social determinants, characterized also as demographic data, highlights the multifactorial nature of health and the need for integrated public health interventions. According to the international guidelines, a crucial non-pharmaceutical intervention towards improvement of health and reduction of the frequency of non-communicable disease onset is exercise/physical activity. Aim: Based on the above, it appears that the problem of health inequalities is serious; however, the available data is limited, especially in Greece. To that end, this study aims to collect evidence from populations in the Region of Thessaly, Greece, who have limited access to health services and to both qualitatively and quantitatively document this problem. Methods: In particular, data from validated questionnaires, blood biomarkers and physiology measurements will be collected in three populations. These comprise members of the urban and rural population, who are both healthy or suffer from non-communicable disease, patients with OUDs who are under medication for addiction treatment with methadone or buprenorphine and incarcerated individuals. The data that will be collected from all volunteers are the following: Demographic data (e.g., body mass index, smoking, alcohol consumption, place of residence, health insurance, educational status, family status, financial status etc), physical activity level through the international physical activity questionnaire (IPAC), quality of life and mental health based on the internationally established questionnaire SF-36, and craving for heroin use (this applies only to the patients with OUDs). In sub-populations, biomarkers of blood oxidative stress and antioxidant potential (e.g., concentrations of glutathione and protein carbonyls, catalase activity and total antioxidant capacity), as well as cardiorespiratory fitness and body composition as indicators of physical activity and health status will also be obtained. All data will be integrated in an interactive digital platform and will be available to health stakeholders, the Greek authorities and everyone who needs to be informed about the problem of health inequalities. Based on these scientifically robust data and evidence-based findings, the research team of the project will draft recommendations and guidelines that will be communicated to all stakeholders. Anticipated outcomes: The problem of limited access to health services that the examined populations face, will be highlighted and targeted actions and policies are expected to be adopted by local and national authorities. In this respect, non-pharmaceutical interventions and guidelines will be proposed towards the trajectory of holistically approaching the global issue of health inequalities.
Первичные конечные точки
- Demographic data [Срок оценки: Data will be collected at Baseline]
Вторичные конечные точки (11)
- Physical activity [Срок оценки: Data will be collected at Baseline]
- Quality of life [Срок оценки: Data will be collected at Baseline]
- Heroin craving [Срок оценки: Data will be collected at Baseline]
- Concentration of reduced glutathione (GSH) [Срок оценки: Data will be collected at Baseline]
- Concentration of protein carbonyls [Срок оценки: Data will be collected at Baseline]
- Total antioxidant capacity (TAC) [Срок оценки: Data will be collected at Baseline]
- Activity of catalase [Срок оценки: Data will be collected at Baseline]
- Cardiorespiratory fitness [Срок оценки: Data will be collected at Baseline]
- Body fat percentage [Срок оценки: Data will be collected at Baseline]
- Lean body mass [Срок оценки: Data will be collected at Baseline]
- Muscle mass [Срок оценки: Data will be collected at Baseline]
Критерии участия
Критерии включения
- Adults (>18 years of age)
- All healthy individuals who reside in rural and urban areas
- All patients with non-communicable diseases who reside in rural and urban areas
- Patients with opioid use disorders under medication for addiction treatment with methadone and buprenorphine
- Individuals incarcerated in correctional facilities
Критерии исключения
- Minors (<18 years of age)
- Individuals with communicable diseases
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Греция · 5 центров
- General Hospital of Larissa — Larissa
- Health structures in the Region of Thessaly — Larissa
- National Organization for the Prevention and Treatment of Addictions (EOPAE) — Larissa
- General Hospital of Trikala — Trikala
- National Organization for the Prevention and Treatment of Addictions (EOPAE), Trikala — Trikala
Публикации
- Veskoukis AS, Tsatsakis A, Kouretas D. Approaching reactive species in the frame of their clinical significance: A toxicological appraisal. Food Chem Toxicol. 2020 Apr;138:111206. doi: 10.1016/j.fct.2020.111206. Epub 2020 Feb 28. PMID 32113950
- Veskoukis AS, Kerasioti E, Priftis A, Kouka P, Spanidis Y, Makri S, Kouretas D. A battery of translational biomarkers for the assessment of the in vitro and in vivo antioxidant action of plant polyphenolic compounds: the biomarker issue. Current Opinion in Toxicology, 13:99-109, 2019.
- Veskoukis AS, Margaritelis NV, Kyparos A, Paschalis V, Nikolaidis MG. Spectrophotometric assays for measuring redox biomarkers in blood and tissues: the NADPH network. Redox Rep. 2018 Dec;23(1):47-56. doi: 10.1080/13510002.2017.1392695. Epub 2017 Oct 31. PMID 29088980
- Veskoukis AS, Kyparos A, Paschalis V, Nikolaidis MG. Spectrophotometric assays for measuring redox biomarkers in blood. Biomarkers. 2016;21(3):208-17. doi: 10.3109/1354750X.2015.1126648. Epub 2016 Jan 26. PMID 26809994
- Dinas PC, On Behalf Of The Students Of Module Introduction To Systematic Reviews, Karaventza M, Liakou C, Georgakouli K, Bogdanos D, Metsios GS. Combined Effects of Physical Activity and Diet on Cancer Patients: A Systematic Review and Meta-Analysis. Nutrients. 2024 Jun 2;16(11):1749. doi: 10.3390/nu16111749. PMID 38892682
- Metsios GS, Moe RH, van der Esch M, van Zanten JJCSV, Fenton SAM, Koutedakis Y, Vitalis P, Kennedy N, Brodin N, Bostrom C, Swinnen TW, Tzika K, Niedermann K, Nikiphorou E, Fragoulis GE, Vlieland TPVM, Van den Ende CHM, Kitas GD; IMPACT-RMD Consortium. The effects of exercise on cardiovascular disease risk factors and cardiovascular physiology in rheumatoid arthritis. Rheumatol Int. 2020 Mar;40(3): PMID 31802210
- Metsios GS, Moe RH, Kitas GD. Exercise and inflammation. Best Pract Res Clin Rheumatol. 2020 Apr;34(2):101504. doi: 10.1016/j.berh.2020.101504. Epub 2020 Apr 2. PMID 32249021
- Poulter M, Coe S, Graham CA, Leach B, Tammam J. A systematic review of the effect of dietary and nutritional interventions on the behaviours and mental health of prisoners. Br J Nutr. 2024 Jul 14;132(1):77-90. doi: 10.1017/S0007114524000849. Epub 2024 Apr 29. PMID 38682285
Идентификаторы
NCT: NCT07558187 · 98 / 25.07.2025