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NCT Number: NCT07677800

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, RM, 00168, Italy

Location contact

Ivo Iavicoli, Professor

CONTACT

[email protected]

00390630155145

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Obesity and Overweight Status

Other

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.

No Intervention (Observational Assessment)

Other

No Intervention (Observational Assessment)

Primary outcomes

  1. Prevalence of Overweight and Obesity

    Time frame: 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.

Secondary outcomes

  1. Change in Work Productivity and Activity Impairment From Baseline to 12 Months

    Time frame: 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.

  2. Change in Work Ability From Baseline to 12 Months

    Time frame: 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.

  3. Change in Health-Related Quality of Life From Baseline to 12 Months

    Time frame: 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.

  4. Change in Psychological General Well-Being From Baseline to 12 Months

    Time frame: 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.

  5. Change in Depression, Anxiety, and Stress Symptoms From Baseline to 12 Months

    Time frame: 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.

  6. Change in Fatigue Severity From Baseline to 12 Months

    Time frame: 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.

  7. Change in Worker Well-Being From Baseline to 12 Months

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ivo Iavicoli, Professor

CONTACT

[email protected]

0039 0630155145

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: OBESIT-A

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 1, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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