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Impact of Overweight, Obesity, and Lifestyle Changes on Work Performance and Well-Being in Medical Residents (OBESIT-A)

4 września 2026 zaktualizowane przez: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Observational Study on the Impact of Overweight and Obesity and Lifestyle Changes on Work Performance and Well-being

The goal of this observational study is to evaluate the impact of overweight, obesity, and lifestyle changes on work performance, work ability, quality of life, and overall well-being in medical residents working in hospital and university settings. The main questions it aims to answer are:

  • Is overweight and obesity associated with reduced work productivity, including absenteeism, presenteeism, and perceived work ability?
  • Is overweight and obesity associated with lower health-related quality of life, psychological well-being, and worker well-being?
  • Do lifestyle improvements and clinically significant weight loss over a 12-month period lead to measurable improvements in work productivity, work ability, quality of life, and well-being?
  • Do changes in physical health, mental health, and organizational factors mediate the relationship between weight loss and occupational outcomes? Participants will undergo assessments at baseline and after 12 months of follow-up. Researchers will evaluate associations between body weight status, health outcomes, and occupational performance over time.

Participants will: Attend occupational health surveillance visits at baseline and at 12 months. Undergo anthropometric measurements, including body mass index (BMI), waist circumference, and blood pressure assessment.

Provide blood samples for routine laboratory evaluation, including metabolic, cardiovascular, inflammatory, and hematological parameters.

Complete validated questionnaires assessing health-related quality of life (SF-12), work ability (Work Ability Index), work productivity and activity impairment (WPAI), fatigue (Fatigue Severity Scale), psychological well-being (PGWBI), mental health (DASS-21), worker well-being (NIOSH WellBQ), and resilience (CD-RISC). Provide information on sociodemographic characteristics, lifestyle habits, medical history, occupational characteristics, and work-related exposures.

The study will estimate the prevalence of overweight and obesity in a cohort of medical residents and investigate their association with occupational and health-related outcomes. Longitudinal analyses will examine whether changes in lifestyle behaviors and body weight are associated with changes in productivity, absenteeism, presenteeism, work ability, quality of life, and well-being over a 12-month observation period. The study will also explore potential mechanisms linking weight status and occupational outcomes, including physical health, psychological health, and organizational factors.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

600

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Włochy
    • RM
      • Rome, RM, Włochy, 00168
        • Rekrutacyjny
        • Fondazione Policlinico Universitario A. Gemelli IRCCS
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko
  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

The study population consists of male and female medical residents (physicians in specialty training) actively working in hospital and university healthcare settings and undergoing routine occupational health surveillance at the Occupational Medicine Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy. Participants will be evaluated for body weight status, lifestyle factors, quality of life, psychological well-being, work ability, and work productivity at baseline and after 12 months of follow-up.

Opis

Inclusion Criteria:

  • Male and female medical residents (physicians in specialty training).
  • Actively working in hospital or university healthcare settings at the time of enrollment.
  • Willing and able to participate in baseline and 12-month follow-up assessments.
  • Provision of written informed consent for study participation and processing of personal data.

Exclusion Criteria:

  • Pregnancy at baseline or occurring during the follow-up period.
  • Presence of severe clinical conditions that significantly impair work ability or performance, including active cancer treatment, unstable cardiovascular disease, major neurological disorders, or diabetes mellitus.
  • Inability or unwillingness to complete study assessments.
  • Refusal or withdrawal of informed consent.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
Medical Residents Cohort
Male and female medical residents undergoing occupational health surveillance, evaluated for body weight status, lifestyle factors, quality of life, well-being, work ability, and work productivity at baseline and after 12 months of follow-up.
Inny: Obesity and Overweight Status
Participants will not receive any study-specific intervention. The study is observational and evaluates body weight status, including normal weight, overweight, and obesity, as well as changes in lifestyle behaviors and body weight over a 12-month follow-up period. Associations between these factors and work productivity, work ability, quality of life, psychological well-being, and overall worker well-being will be assessed through clinical evaluations, laboratory testing, and validated questionnaires.
Inny: No Intervention (Observational Assessment)
No Intervention (Observational Assessment)

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Prevalence of Overweight and Obesity
Ramy czasowe: Baseline
Prevalence of overweight and obesity among medical residents, assessed using standardized anthropometric measurements including body mass index (BMI) and waist circumference. Participants will be classified according to BMI categories (normal weight, overweight, and obesity) to estimate the burden of excess body weight in the study population.
Baseline

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in Work Productivity and Activity Impairment From Baseline to 12 Months
Ramy czasowe: Baseline and 12 months
Change in work productivity and activity impairment will be assessed using the Work Productivity and Activity Impairment Questionnaire (WPAI). Outcomes will be reported as percentages from 0% to 100%, including absenteeism, presenteeism, overall work productivity impairment, and activity impairment. Higher percentages indicate greater impairment and worse productivity.
Baseline and 12 months
Change in Work Ability From Baseline to 12 Months
Ramy czasowe: Baseline and 12 months
Change in work ability will be assessed using the Work Ability Index (WAI). The total score ranges from 7 to 49 points, with higher scores indicating better work ability.
Baseline and 12 months
Change in Health-Related Quality of Life From Baseline to 12 Months
Ramy czasowe: Baseline and 12 months
Change in health-related quality of life will be assessed using the 12-Item Short Form Health Survey (SF12). Physical and mental component scores will be reported separately. Scores range from 0 to 100, with higher scores indicating better health-related quality of life.
Baseline and 12 months
Change in Psychological General Well-Being From Baseline to 12 Months
Ramy czasowe: Baseline and 12 months
Change in psychological well-being will be assessed using the Psychological General Well-Being Index (PGWBI). The total score ranges from 0 to 110, with higher scores indicating better psychological well-being.
Baseline and 12 months
Change in Depression, Anxiety, and Stress Symptoms From Baseline to 12 Months
Ramy czasowe: Baseline and 12 months
Change in mental health symptoms will be assessed using the Depression Anxiety Stress Scales-21 (DASS21). Depression, anxiety, and stress subscale scores will be reported separately. Each subscale score ranges from 0 to 42 after multiplication by 2, with higher scores indicating greater symptom severity.
Baseline and 12 months
Change in Fatigue Severity From Baseline to 12 Months
Ramy czasowe: Baseline and 12 months
Change in fatigue severity will be assessed using the Fatigue Severity Scale (FSS). The total score ranges from 9 to 63, with higher scores indicating greater fatigue severity.
Baseline and 12 months
Change in Worker Well-Being From Baseline to 12 Months
Ramy czasowe: Baseline and 12 months
Change in worker well-being will be assessed using the National Institute for Occupational Safety and Health Worker Well-Being Questionnaire. Domain scores will be reported separately according to the questionnaire scoring instructions. Higher scores will indicate better worker well-being, unless otherwise specified for individual domains.
Baseline and 12 months

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Śledczy

  • Główny śledczy: Ivo Iavicoli, Professor, Fondazione Policlinico Gemelli IRCCS - Roma

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

26 czerwca 2026

Zakończenie podstawowe (Szacowany)

15 czerwca 2028

Ukończenie studiów (Szacowany)

30 czerwca 2028

Daty rejestracji na studia

Pierwszy przesłany

8 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

25 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

1 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

8 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

4 września 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 27283

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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