Enabling Environments for Non-communicable Disease Risk Reduction in Ethiopia
NCT07442318
Behavior, Disease Attributes
Addis Ababa, Ethiopia
View Trial DetailsNCT Number: NCT07558187
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
General Hospital of Larissa, Larissa, Greece
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Data will be collected at Baseline
Body mass index, smoking, alcohol consumption, place of residence, health insurance, educational status, family status and financial status will be collected among others through a questionnaire.
Time frame: Data will be collected at Baseline
It will be measured through the international physical activity questionnaire (IPAC)
Time frame: Data will be collected at Baseline
It will be measured through the SF-36 questionnaire. This instrument has a physical component and a mental component. Each domain is scored from 0 to 100. Higher score = better health or better quality of life.
Time frame: Data will be collected at Baseline
It will be measured using the heroin craving questionnaire (HCQ). The score is calculated with a 7-point Likert scale ranging from 1 (i.e., strongly disagree) to 7 (i.e., strongly agree). Higher values = higher craving for heroin use. It applies only to the patients with opioid use disorders.
Time frame: Data will be collected at Baseline
The concentration of GSH, a crucial antioxidant metabolite, will be measured in the blood of sub-population of the volunteers
Time frame: Data will be collected at Baseline
Concentration of protein carbonyls, a biomarker of protein oxidation, will be measured in the blood of sub-population of the volunteers
Time frame: Data will be collected at Baseline
TAC is crude biomarker of antioxidant status and will be measured in the blood of sub-population of the volunteers
Time frame: Data will be collected at Baseline
Activity of catalase, a substantial antioxidant enzyme, will be measured in blood of sub-population of the volunteers
Time frame: Data will be collected at Baseline
A marker, which is associated to physical activity and health status, will be measured in sub-population of the volunteers. In particular, resting energy expenditure and resting heart rate will be assessed through metabolic gas analyzer.
Time frame: Data will be collected at Baseline
It is associated to physical activity and health status and will be measured in sub-population of the volunteers through bioelectrical impedance analysis.
Time frame: Data will be collected at Baseline
It is associated to physical activity and health status and will be measured (in kg) in sub-population of the volunteers through bioelectrical impedance analysis.
Time frame: Data will be collected at Baseline
It is associated to physical activity and health status and will be measured (in kg) in sub-population of the volunteers through bioelectrical impedance analysis.
Contact information is provided by the study sponsor or research team.
University of Thessaly
Other
Assessment of Lifestyle Parameters and Biomarkers of Biochemistry and Physiology to Address Health Inequalities: An Exploratory Cohort Study
Acronym: CHANCE
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