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

4 de setembro de 2026 atualizado 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Observacional

Inscrição (Estimado)

600

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Itália
    • RM
      • Rome, RM, Itália, 00168
        • Recrutamento
        • Fondazione Policlinico Universitario A. Gemelli IRCCS
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
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.
Outro: 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.
Outro: No Intervention (Observational Assessment)
No Intervention (Observational Assessment)

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Prevalence of Overweight and Obesity
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in Work Productivity and Activity Impairment From Baseline to 12 Months
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigadores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

26 de junho de 2026

Conclusão Primária (Estimado)

15 de junho de 2028

Conclusão do estudo (Estimado)

30 de junho de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

8 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

25 de junho de 2026

Primeira postagem (Real)

1 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

8 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

4 de setembro de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 27283

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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