Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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

4. September 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

600

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Italien
    • RM
      • Rome, RM, Italien, 00168
        • Rekrutierung
        • Fondazione Policlinico Universitario A. Gemelli IRCCS
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.
Sonstiges: 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.
Sonstiges: No Intervention (Observational Assessment)
No Intervention (Observational Assessment)

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Prevalence of Overweight and Obesity
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Work Productivity and Activity Impairment From Baseline to 12 Months
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

26. Juni 2026

Primärer Abschluss (Geschätzt)

15. Juni 2028

Studienabschluss (Geschätzt)

30. Juni 2028

Studienanmeldedaten

Zuerst eingereicht

8. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

25. Juni 2026

Zuerst gepostet (Tatsächlich)

1. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

8. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. September 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 27283

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren