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

4 de septiembre de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

De observación

Inscripción (Estimado)

600

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Ivo Iavicoli, Professor
  • Número de teléfono: 0039 0630155145
  • Correo electrónico: Ivo.Iavicoli@unicatt.it

Ubicaciones de estudio

  • Italia
    • RM
      • Rome, RM, Italia, 00168
        • Reclutamiento
        • Fondazione Policlinico Universitario A. Gemelli IRCCS
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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.
Otro: 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.
Otro: No Intervention (Observational Assessment)
No Intervention (Observational Assessment)

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Prevalence of Overweight and Obesity
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Work Productivity and Activity Impairment From Baseline to 12 Months
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigadores

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

26 de junio de 2026

Finalización primaria (Estimado)

15 de junio de 2028

Finalización del estudio (Estimado)

30 de junio de 2028

Fechas de registro del estudio

Enviado por primera vez

8 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

25 de junio de 2026

Publicado por primera vez (Actual)

1 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

8 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

4 de septiembre de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 27283

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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