- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07677800
Impact of Overweight, Obesity, and Lifestyle Changes on Work Performance and Well-Being in Medical Residents (OBESIT-A)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ivo Iavicoli, Professor
- Phone Number: 0039 0630155145
- Email: Ivo.Iavicoli@unicatt.it
Study Locations
-
-
RM
-
Rome, RM, Italy, 00168
- Fondazione Policlinico Universitario A. Gemelli IRCCS
-
Contact:
- Ivo Iavicoli, Professor
- Phone Number: 00390630155145
- Email: Ivo.Iavicoli@unicatt.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and 12 months
|
|
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.
|
Baseline and 12 months
|
|
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.
|
Baseline and 12 months
|
|
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.
|
Baseline and 12 months
|
|
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.
|
Baseline and 12 months
|
|
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.
|
Baseline and 12 months
|
|
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.
|
Baseline and 12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ivo Iavicoli, Professor, Fondazione Policlinico Gemelli IRCCS - Roma
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nutrition Disorders
- Overnutrition
- Body Weight
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Overweight
- Obesity
- Diagnostic Techniques and Procedures
- Diagnosis
- Physiological Phenomena
- Biochemical Phenomena
- Chemical Phenomena
- Physical Examination
- Body Weights and Measures
- Body Constitution
- Metabolism
- Body Fat Distribution
- Body Composition
- Adiposity
Other Study ID Numbers
- 27283
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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