NCT07558187

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
31mo left

Started Mar 2026

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
recruiting

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 Progress6%
Mar 2026Dec 2028

Study Start

First participant enrolled

March 10, 2026

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2026

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 30, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

2.1 years

First QC Date

April 6, 2026

Last Update Submit

April 22, 2026

Conditions

Keywords

Health inequalitiesPhysical activity/exerciseDemographicsQuality of lifeHeroin cravingOxidative stressAntioxidantsResting energy expenditureBody compositionAlcoholBody mass indexSmokingCardiorespiratory fitnessOpioid use disorders

Outcome Measures

Primary Outcomes (1)

  • Demographic data

    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.

    Data will be collected at Baseline

Secondary Outcomes (11)

  • Physical activity

    Data will be collected at Baseline

  • Quality of life

    Data will be collected at Baseline

  • Heroin craving

    Data will be collected at Baseline

  • Concentration of reduced glutathione (GSH)

    Data will be collected at Baseline

  • Concentration of protein carbonyls

    Data will be collected at Baseline

  • +6 more secondary outcomes

Study Arms (6)

Patients with non-communicable diseases - residents of rural areas

No intervention

Patients with non-communicable diseases - residents of urban areas

No intervention

Healthy volunteers - residents of rural areas

No intervention

Healthy volunteers - residents of urban areas

No intervention

Patients with opioid use disorders under medication for addiction treatment

No intervention

Individuals incarcerated in correctional facilities (prisons)

No intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Sources of study populations: Hospitals; Other health centers and structures in cities, towns or villages; National Organization for the Prevention and Treatment of Addictions (EOPAE); Correctional facilities (prisons)

You may qualify if:

  • 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

You may not qualify if:

  • Minors (\<18 years of age)
  • Individuals with communicable diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

General Hospital of Larissa

Larissa, Greece

NOT YET RECRUITING

Health structures in the Region of Thessaly

Larissa, Greece

RECRUITING

National Organization for the Prevention and Treatment of Addictions (EOPAE)

Larissa, Greece

NOT YET RECRUITING

General Hospital of Trikala

Trikala, Greece

NOT YET RECRUITING

National Organization for the Prevention and Treatment of Addictions (EOPAE), Trikala

Trikala, Greece

NOT YET RECRUITING

Related Publications (32)

  • Veskoukis AS, Tsatsakis A, Kouretas D. Approaching reactive species in the frame of their clinical significance: a toxicological appraisal. Food and Chemical Toxicology, 138:111206, 2020.

    BACKGROUND
  • 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.

    BACKGROUND
  • Veskoukis AS, Margaritelis NV, Kyparos A, Paschalis V, Nikolaidis MG. Spectrophotometric assays for measuring redox biomarkers in blood and tissues: the NADPH network. Redox Report, 23(1):47-56, 2018.

    BACKGROUND
  • Veskoukis AS, Kyparos A, Paschalis V, Nikolaidis MG. Spectrophotometric assays for measuring redox biomarkers in blood. Biomarkers, 21(3):208-17, 2016.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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):347-357. doi: 10.1007/s00296-019-04483-6.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • da Costa, F.A.; Verschuuren, M.; Andersen, Y.; Stürup-Toft, S.; Lopez-Acuña, D.; Ferreira-Borges, C. The WHO Prison Health Framework: A framework for assessment of prison health system performance. Eur. J. Public Health 2022, 32, 565-570.

    BACKGROUND
  • Schoenthaler, S., Gast, D., Giltay, E. J., & Amos, S. (2023). The Effects of Vitamin-Mineral Supplements on Serious Rule Violations in Correctional Facilities for Young Adult Male Inmates: A Randomized Controlled Trial. Crime & Delinquency, 69(4), 822-840.

    BACKGROUND
  • Leventelis C, Barmpas PT, Nellas I, Tasoulis S, Veskoukis AS, Tsironi M. COVID-19 Pandemic Detrimentally Affects Craving and Quality of Life in Patients Under Medication-Assisted Treatment with Buprenorphine and Methadone: The Issue of Medication Dose. Psychiatry International, 5, 867-882, 2024.

    BACKGROUND
  • Leventelis C, Makri S, Ververi A, Papageorgiou K, Tentolouri A, Mountzouridi E, Tekos F, Barmpas PT, Tasoulis S, Metsios GS, Kouretas D, Veskoukis AS. Pomegranate juice ameliorates craving and oxidative stress on patients under medication for opioid addiction treatment with methadone and buprenorphine: a Ranzomised Controlled Trial. Clinical Nutrition ESPEN, 66, 34-44, 2025a.

    BACKGROUND
  • Leventelis C, Veskoukis AS, Rojas Gil AP, Papadopoulos P, Garderi M, Angeli A, Kampitsi A, Tsironi M. Methadone and Buprenorphine as Medication for Addiction Treatment Diversely Affect Inflammation and Craving Depending on Their Doses. Pharmacy (Basel), 13(2), 40, 2025b.

    BACKGROUND
  • Leventelis C, Barmpas PT, Kampitsi A, Iliopoulou K, Toutouktsi N, Malakopoulos P, Tasoulis S, Veskoukis AS. Pomegranate juice consumption improves sleep quality and melatonin concentration of patients with opioid use disorders under medication-assisted treatment with methadone and buprenorphine: a randomized controlled trial. Substance Use and Addiction Journal, 46(4):981-993, 2025c.

    BACKGROUND
  • Edwards, A., Hung, R., Levin, J. B., Forthun, L., Sajatovic, M., & McVoy, M. (2023). Health disparities among rural individuals with mental health conditions: A systematic literature review. Rural Mental Health, 47(3), 163-178. https://doi.org/10.1037/rmh0000228

    BACKGROUND
  • Cosgrave, C., Malatzky, C., & Gillespie, J. (2019). Social determinants of health and the rural health care gap: A scoping review. International Journal of Environmental Research and Public Health, 18(8), 2668. https://doi.org/10.3390/ijerph16030314

    BACKGROUND
  • Probst, J. C., Eberth, J. M., & Crouch, E. (2019). Structural urbanism contributes to poorer health outcomes for rural America. Health Affairs, 39(12), 2017-2024. https://doi.org/10.1377/hlthaff.2019.00914

    BACKGROUND
  • Holt-Lunstad, J. (2018). Why social relationships are important for physical health: A systems approach to understanding and modifying risk and protection. Annual Review of Psychology, 69, 437-458. https://doi.org/10.1146/annurev-psych-122216-011902

    BACKGROUND
  • Umberson, D., & Donnelly, R. (2023). Social isolation: An unequally distributed health hazard. Annual Review of Sociology, 49(1), 379-399. https://doi.org/10.1146/annurev-soc-031021-012001

    BACKGROUND
  • Aldridge, R. W., Story, A., Hwang, S. W., Nordentoft, M., Luchenski, S. A., Hartwell, G., & Hayward, A. C. (2018). Morbidity and mortality in homeless individuals, prisoners, sex workers, and individuals with substance use disorders in high-income countries: A systematic review and meta-analysis. https://doi.org/10.1016/S0140-6736(17)31869-X

    BACKGROUND
  • Tsai, J., O'Toole, T., & Kearney, L. K. (2017). Homelessness as a public mental health and social problem: New knowledge and solutions. Psychological Services, 14(2), 113-117. https://doi.org/10.1037/ser0000164

    BACKGROUND
  • Luchenski, S., Maguire, N., Aldridge, R. W., et al. (2018). What works in inclusion health: Effective interventions for marginalised and excluded populations. The Lancet, 391(10117), 266-280. https://doi.org/10.1016/S0140-6736(17)31959-1

    BACKGROUND
  • Triantafyllou, C., Latsou, D., Psiakis, V., Pierrakos, G., & Breda, J. (2025). Addressing health inequalities in Greece: A comprehensive framework for socioeconomic determinants of health. Healthcare, 13(19), 2394. https://doi.org/10.3390/healthcare13192394

    BACKGROUND
  • Krieger N. A glossary for social epidemiology: part II. J Epidemiol Community Health. 2001;55(55):693-700. doi: 10.1136/jech.55.10.693.

    BACKGROUND
  • OECD. (2025a). Health at a Glance 2025: OECD indicators. OECD Publishing. https://www.oecd.org/en/publications/health-at-a-glance-2025_8f9e3f98-en.html

    BACKGROUND
  • OECD. (2023). Health at a Glance: Europe 2023. https://www.oecd.org/en/publications/health-at-a-glance-2023_7a7afb35-en.html

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  • Douki, S., & Spyridakis, E. (2004). Inequalities in access to health services: The case of Greece. HAPSc Policy Briefs Series, 5(2), 27. https://doi.org/10.12681/hapscpbs.40777

    BACKGROUND
  • World Health Organization. (2025a). World report on social determinants of health equity 2025. WHO. https://www.who.int/teams/social-determinants-of-health/equity-and-health/world-report-on-social-determinants-of-health-equity

    BACKGROUND
  • World Health Organization. (2021). Social determinants of health and health inequalities in Europe. WHO Regional Office for Europe. https://www.who.int/europe/health-topics/social-determinants-of-health

    BACKGROUND
  • McCartney, G., Popham, F., McMaster, R., & Cumbers, A. (2019). Defining health and health inequalities. Public Health, 172, 22-30. https://doi.org/10.1016/j.puhe.2019.03.023

    BACKGROUND
  • Sartorius, N. (2006). The meanings of health and its promotion. Croatian Medical Journal, 47(4), 662-664. https://pmc.ncbi.nlm.nih.gov/articles/PMC2080455/

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    BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples, data from questionnaires, data from biochemical measurements, data from physiology measurements

MeSH Terms

Conditions

Noncommunicable DiseasesOpioid-Related DisordersMotor ActivitySmoking

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersBehavior

Central Study Contacts

Aristidis S Veskoukis, Associate Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 6, 2026

First Posted

April 30, 2026

Study Start

March 10, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

April 30, 2026

Record last verified: 2026-04

Locations