ObesityOBESIT-ANCT07677800
Impact of Overweight, Obesity, and Lifestyle Changes on Work Performance and Well-Being in Medical Residents
An observational study of Obesity and Overweight, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Obesity and Overweight Status
- How many people
- 600 participants
- Where
- 1 siteItaly
- Study dates
- 26 Jun 2026to 30 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, RM, 00168
Ivo Iavicoli, Professor, 00390630155145, Ivo.Iavicoli@unicatt.it
About this study
Official title: 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.
Read more
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.
- Conditions
- Obesity, Overweight
- Being tested
- Obesity and Overweight Status, No Intervention (Observational Assessment)
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obesity and Overweight StatusOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Obesity and Overweight Status; Other: No Intervention (Observational Assessment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Overweight and Obesity
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.
Measured: Baseline
Secondary outcomes (7)
Change in Work Productivity and Activity Impairment From Baseline to 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.
Measured: Baseline and 12 months
Change in Work Ability From Baseline to 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.
Measured: Baseline and 12 months
Change in Health-Related Quality of Life From Baseline to 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.
Measured: Baseline and 12 months
Change in Psychological General Well-Being From Baseline to 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.
Measured: Baseline and 12 months
Change in Depression, Anxiety, and Stress Symptoms From Baseline to 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.
Measured: Baseline and 12 months
Change in Fatigue Severity From Baseline to 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.
Measured: Baseline and 12 months
Change in Worker Well-Being From Baseline to 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.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start26 Jun 2026
- Primary completion15 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ivo Iavicoli, Professor, Principal investigator, Fondazione Policlinico Gemelli IRCCS - Roma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07677800
- Sponsor's protocol ID
- 27283
- Acronym
- OBESIT-A
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Impact of Overweight and Obesity and Lifestyle Changes on Work Performance and Well-being
- ClinicalTrials.gov ID
- NCT07677800
- Acronym / sponsor ID
- OBESIT-A / 27283
- Conditions
- Obesity, Overweight
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 26 Jun 2026 (actual)
- Primary completion
- 15 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medical Residents Cohort | – | Other: Obesity and Overweight Status, Other: No Intervention (Observational Assessment)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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Obesity and Overweight StatusParticipants 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. | Other | Medical Residents Cohort |
| No Intervention (Observational Assessment)No Intervention (Observational Assessment) | Other | Medical Residents Cohort |
Primary outcome
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.
7 secondary outcomes
Change in Work Productivity and Activity Impairment From Baseline to 12 Months
Time frame: Baseline and 12 months
Change in Work Ability From Baseline to 12 Months
Time frame: Baseline and 12 months
Change in Health-Related Quality of Life From Baseline to 12 Months
Time frame: Baseline and 12 months
Change in Psychological General Well-Being From Baseline to 12 Months
Time frame: Baseline and 12 months
Change in Depression, Anxiety, and Stress Symptoms From Baseline to 12 Months
Time frame: Baseline and 12 months
Change in Fatigue Severity From Baseline to 12 Months
Time frame: Baseline and 12 months
Change in Worker Well-Being From Baseline to 12 Months
Time frame: Baseline and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ivo Iavicoli, Professor principal investigator
Fondazione Policlinico Gemelli IRCCS - Roma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Overweight, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ivo Iavicoli, Professor (0039 0630155145, Ivo.Iavicoli@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Overweight and Obesity (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.