Obesity and Obesity-related Medical ConditionsNCT06768892
Combating Obesity in a Workplace
An observational study of Obesity and Obesity-related Medical Conditions, run by Tanta University at 1 site in Egypt.
Trial summary
Aim of the work: to assess the impact of 3-months workplace weight control program on both work ability and the severity of Metabolic Syndrome. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity and Obesity-related Medical Conditions
- What is being tested?
- Dietary Intervention, Cognitive Behavioral Therapy (CBT) and Physical exercise training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 154 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to Apr 2025
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: participants will involve manual workers and office employees who are manual workers and office employees who had BMI of ≥25 kg/m2 , history of repeated sick leaves from work related health problems especially musculoskeletal disorders (MSDs) and obesity related comorbidities as hypertension, diseases of the heart, hyperlipidemia ,diabetes and metabolic syndrome, and their age is above 18 years old .
Who may be able to join
- Manual workers and office employees
- BMI of ≥25 kg/m2 ,
- History of repeated sick leaves from work related health problems especially (musculoskeletal disorders (MSDs) and obesity related comorbidities as hypertension, diseases of the heart, hyperlipidemia ,Diabetes Mellitus and Metabolic syndrome)
- Age is above 18 years old
Who cannot join
- Age lower than 18
- BMI 24.9 and less
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Workplace Weight Control Program: Combating Obesity in a Multinational Factory in Egypt.
Aim of the work: to assess the impact of 3-months workplace weight control program on both work ability and the severity of Metabolic Syndrome.
Read the detailed description
Obesity is a significant public health concern worldwide. It is a multifactorial disease characterized by its complexity, as it is influenced by many factors as gut- brain axis, gut microbiome, genetics, behavioral, environmental ,and energy expenditure. A rising prevalence of obesity is observed in tandem with the acceleration of urbanization and economic transition.The obesity rate among employees and workers who constituting primarily the working population, has consequently witnessed a substantial surge and has garnered significant attention as a prominent public health issue.
According to (WHO), Egypt ranked 18th with highest prevalence of obesity globally and among the leading nations in obesity worldwide. The Prevalence of obesity among adults in Egypt in 2019 according to "100 million health survey" was 39.8% compared to 36% in 2017 in "STEP wise survey". In Egypt, the economic repercussions of obesity is nearly 62 Billion Egyptian pounds annually. This is the expense incurred for treatment comorbidities associated with obesity in adults which is direct health costs and indirect costs caused by decreased work abilities , work absenteeism, and may reach total disability.
Obesity is associated with metabolic abnormalities of metabolic syndrome (MetS). The prominent clinical features of this syndrome include abdominal adiposity, atherogenic dyslipidemia, the elevated blood pressure, insulin resistance, and proinflammatory and prothrombotic conditions.
The global prevalence of metabolic syndrome has been approximated to be approximately 25%. The observed rise in MetS is concomitant with the escalating prevalence of obesity. Obese populations have been associated with a greater prevalence of MetS, with values ranging from 59.6% to 75.7% of the individuals examined. According to the findings of the Centers for Disease Control and Prevention, there has been an observed rise in the prevalence of Metabolic Syndrome (MetS) among the adult population in the United States. Specifically, the prevalence has increased from 25.3% during the period of 1988-1994 to 34.2% during the period of 2007-2012. The subject of serious concern revolves around the impact of MetS within the working population, as it is closely linked to instances of job absenteeism resulting from illness, diminished productivity, and escalated healthcare expenditures.
Therefore, implementing of interventions aimed at preventing and treating MetS can significantly influence healthcare expenses and costs associated with short-term incapacity, while also enhancing job capacity. Emphasizing the potential for increased health-related productivity among the working population through the mitigation of metabolic syndrome severity.
The concept of work ability encompasses an individual's capacity to engage in work-related activities, and the intricate interplay between various cognitive, physical, and social factors, as well as the influence of diverse environmental elements. Obesity has a tremendous effect on the employee work ability, frequent absenteeism from work and long sick leave as obese workers and employees struggle to remain in the workforce.
Worksites are an appropriate setting and places of choice for implementing obesity intervention programs. An employee dedicates a significant amount of time to their work , and Workplaces possess various attributes, including well-established communication channels and social support systems, which have the potential to facilitate the implementation of multi-component, ecological, and individual interventions. In this context, the aim of our research is to implement 3- months obesity control program to improve work ability and to control the severity of the metabolic syndrome among of employees and workers in a multinational factory in Egypt.
- Being tested
- Dietary Intervention, Cognitive Behavioral Therapy (CBT), Physical exercise training
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary InterventionOther
Also called Cognitive Behavioral Therapy (CBT), Physical exercise training
Each study participant will offer a tailored diet regimen according to age, sex, health status, physical activity and type of work either (office work or physical demanding work) after A 24-hour Dietary recall to calculate average calories requirements for each study participant separately. The participants' meals will be based on Mediterranean Diet and The Dietary Approaches to Stopping Hypertension (DASH Diet) as they proved effectiveness in lowering the risk of cardiovascular disease, insulin resistance, hypertension, obesity and Metabolic Syndrome. Dietary intervention aimed to the extent that 5-10% reduction in body weight, following the guideline of prevention and treatment of obesity.
Cognitive Behavioral Therapy (CBT)Behavioural
CBT method will be adapted and customized to facilitate a transition towards a heightened level of physical activity and to address the emotional and practical difficulties associated with weight loss. This encompassed assisting the participants in establishing attainable weight loss goals, identifying individualized approaches to manage appetite, sustaining healthy habits, and navigating social environments and circumstances related to food. The aforementioned factors were deliberated upon within the context of both group-based and individual settings, adhering to a meticulously customized guideline. This guideline encompassed the incorporation of positive thinking tactics, accompanied by assigned tasks to be completed between each session. The Cognitive Behavioral Therapy (CBT) intervention was administered as a 20-minute component within the weekly therapy sessions. cognitive-behavioral therapy (CBT) in conjunction with lif
Physical exercise trainingOther
A weekly session of physical exercise training lasting 10 to 20 minutes will be incorporated at the workplace. The primary objective of the sessions was to increase muscle mass in the lower limbs for the purpose of sustaining physical capacity and boosting quiescent metabolism. The exercises comprised squats involving one or two legs, performed with or without dumbbells and core balls, as well as lunges performed while strolling forward and to each side. Additional exercises that emphasized overall strength encompassed shoulder and arm movements, as well as abdominal and back extension exercises. Participants were encouraged to execute the strength training exercises depicted in the program's takeout pamphlets twice per week. Furthermore, participants will be motivated to engage in aerobic leisure activities for a duration of two hours per week, including bicycling, walking, running, swimming, or participating in various sports.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of severity of the Metabolic Syndrome components
The change in the severity of the metabolic syndrome components following 3-months obesity control intervention in comparison with the baseline.
All participants were assessed for the five criteria of metabolic syndrome (according to IDF\&AHA): Metabolic syndrome was diagnosed if study Participants have at least three of the following five items: (1) Central obesity (waist circumference ≥ 102cm in male; ≥ 88 cm in female),(2) Blood pressure ≥130/85 mmhg,(3) Dyslipidemia (TG ≥ 150mg/dl), (4) Dyslipidemia (HDL-C < 40mg/dl in male; < 50mg/dl in female), and(5)Fasting blood glucose ≥ 110mg/dl.
The blood pressure of participants in the office setting will be assessed and venous blood samples will be collected in order to assess blood lipids and fasting blood glucose levels. The safety blood profile will be conducted using established methodologies in a qualified laboratory specializing in clinical chemistry.
Measured: 3 months
Secondary outcomes (1)
Work Ability of participants
The Work ability of the study subjects will be measured before and after the obesity management intervention program using a standard questionnaire named Work Ability Index. The questionnaire comprises seven items, each utilizing a variable scoring system. The first assesses individual's present work capacity in relation to their best level of work capacity achieved in the past( 0 to 10). Second measures work capacity in respect to job expectations(2 to 10).Third pertains to the "number of current diseases diagnosed by a physician" (1to 7). The fourth pertains to the assessment of job impairment caused by diseases, (1 to 6). The fifth pertains to sick leave taken within the previous year, (1 to 5). sixth pertains to the individual's self-assessment of their work abilities during the past two years, (1, 4, or 7). Seventh element in the sequence is denoted as "mental resources" 1 to 4. WAI total score ranges from 2 to 49, low ( 2 - 27), medium (28 - 36), good(37-43),very good(44-49)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start1 Jan 2025 (estimated)
- Primary completion31 Mar 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obesity and Obesity-related Medical ConditionsStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Mohammed Elghazally, Tanta University
- Investigators
- Rania El sallamy, Study director, Tanta university faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06768892
- Sponsor's protocol ID
- obesity in a workplace
- Status last verified
- Jan 2025
- First submitted
- 31 Dec 2024
- Last updated
- 10 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Andersen LL, Izquierdo M, Sundstrup E. Overweight and obesity are progressively associated with lower work ability in the general working population: cross-sectional study among 10,000 adults. Int Arch Occup Environ Health. 2017 Nov;90(8):779-787. doi: 10.1007/s00420-017-1240-0. Epub 2017 Jun 28.
PubMed 28660321Guzman M, Zbella E, Alvarez SS, Nguyen JL, Imperial E, Troncale FJ, Holub C, Mallhi AK, VanWyk S. Effect of an intensive lifestyle intervention on the prevalence of metabolic syndrome and its components among overweight and obese adults. J Public Health (Oxf). 2020 Nov 23;42(4):828-838. doi: 10.1093/pubmed/fdz170.
PubMed 31840755
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Workplace Weight Control Program: Combating Obesity in a Multinational Factory in Egypt.
- ClinicalTrials.gov ID
- NCT06768892
- Acronym / sponsor ID
- obesity in a workplace
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 10 Jan 2025 (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.
Aim of the work: to assess the impact of 3-months workplace weight control program on both work ability and the severity of Metabolic Syndrome.
Detailed description
Obesity is a significant public health concern worldwide. It is a multifactorial disease characterized by its complexity, as it is influenced by many factors as gut- brain axis, gut microbiome, genetics, behavioral, environmental ,and energy expenditure. A rising prevalence of obesity is observed in tandem with the acceleration of urbanization and economic transition.The obesity rate among employees and workers who constituting primarily the working population, has consequently witnessed a substantial surge and has garnered significant attention as a prominent public health issue.
According to (WHO), Egypt ranked 18th with highest prevalence of obesity globally and among the leading nations in obesity worldwide. The Prevalence of obesity among adults in Egypt in 2019 according to "100 million health survey" was 39.8% compared to 36% in 2017 in "STEP wise survey". In Egypt, the economic repercussions of obesity is nearly 62 Billion Egyptian pounds annually. This is the expense incurred for treatment comorbidities associated with obesity in adults which is direct health costs and indirect costs caused by decreased work abilities , work absenteeism, and may reach total disability.
Obesity is associated with metabolic abnormalities of metabolic syndrome (MetS). The prominent clinical features of this syndrome include abdominal adiposity, atherogenic dyslipidemia, the elevated blood pressure, insulin resistance, and proinflammatory and prothrombotic conditions.
The global prevalence of metabolic syndrome has been approximated to be approximately 25%. The observed rise in MetS is concomitant with the escalating prevalence of obesity. Obese populations have been associated with a greater prevalence of MetS, with values ranging from 59.6% to 75.7% of the individuals examined. According to the findings of the Centers for Disease Control and Prevention, there has been an observed rise in the prevalence of Metabolic Syndrome (MetS) among the adult population in the United States. Specifically, the prevalence has increased from 25.3% during the period of 1988-1994 to 34.2% during the period of 2007-2012. The subject of serious concern revolves around the impact of MetS within the working population, as it is closely linked to instances of job absenteeism resulting from illness, diminished productivity, and escalated healthcare expenditures.
Therefore, implementing of interventions aimed at preventing and treating MetS can significantly influence healthcare expenses and costs associated with short-term incapacity, while also enhancing job capacity. Emphasizing the potential for increased health-related productivity among the working population through the mitigation of metabolic syndrome severity.
The concept of work ability encompasses an individual's capacity to engage in work-related activities, and the intricate interplay between various cognitive, physical, and social factors, as well as the influence of diverse environmental elements. Obesity has a tremendous effect on the employee work ability, frequent absenteeism from work and long sick leave as obese workers and employees struggle to remain in the workforce.
Worksites are an appropriate setting and places of choice for implementing obesity intervention programs. An employee dedicates a significant amount of time to their work , and Workplaces possess various attributes, including well-established communication channels and social support systems, which have the potential to facilitate the implementation of multi-component, ecological, and individual interventions. In this context, the aim of our research is to implement 3- months obesity control program to improve work ability and to control the severity of the metabolic syndrome among of employees and workers in a multinational factory in Egypt.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- participants will involve manual workers and office employees who are manual workers and office employees who had BMI of ≥25 kg/m2 , history of repeated sick leaves from work related health problems especially musculoskeletal disorders (MSDs) and obesity related comorbidities as hypertension, diseases of the heart, hyperlipidemia ,diabetes and metabolic syndrome, and their age is above 18 years old .
Key inclusion criteria (4 listed)
- Manual workers and office employees
- BMI of ≥25 kg/m2 ,
- History of repeated sick leaves from work related health problems especially (musculoskeletal disorders (MSDs) and obesity related comorbidities as hypertension, diseases of the heart, hyperlipidemia ,Diabetes Mellitus and Metabolic syndrome)
- Age is above 18 years old
Key exclusion criteria (2 listed)
- Age lower than 18
- BMI 24.9 and less
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 |
|---|---|---|
| Dietary InterventionAlso: Cognitive Behavioral Therapy (CBT), Physical exercise trainingEach study participant will offer a tailored diet regimen according to age, sex, health status, physical activity and type of work either (office work or physical demanding work) after A 24-hour Dietary recall to calculate average calories requirements for each study participant separately. The participants' meals will be based on Mediterranean Diet and The Dietary Approaches to Stopping Hypertension (DASH Diet) as they proved effectiveness in lowering the risk of cardiovascular disease, insulin resistance, hypertension, obesity and Metabolic Syndrome. Dietary intervention aimed to the extent that 5-10% reduction in body weight, following the guideline of prevention and treatment of obesity. | Other | – |
| Cognitive Behavioral Therapy (CBT)CBT method will be adapted and customized to facilitate a transition towards a heightened level of physical activity and to address the emotional and practical difficulties associated with weight loss. This encompassed assisting the participants in establishing attainable weight loss goals, identifying individualized approaches to manage appetite, sustaining healthy habits, and navigating social environments and circumstances related to food. The aforementioned factors were deliberated upon within the context of both group-based and individual settings, adhering to a meticulously customized guideline. This guideline encompassed the incorporation of positive thinking tactics, accompanied by assigned tasks to be completed between each session. The Cognitive Behavioral Therapy (CBT) intervention was administered as a 20-minute component within the weekly therapy sessions. cognitive-behavioral therapy (CBT) in conjunction with lif | Behavioural | – |
| Physical exercise trainingA weekly session of physical exercise training lasting 10 to 20 minutes will be incorporated at the workplace. The primary objective of the sessions was to increase muscle mass in the lower limbs for the purpose of sustaining physical capacity and boosting quiescent metabolism. The exercises comprised squats involving one or two legs, performed with or without dumbbells and core balls, as well as lunges performed while strolling forward and to each side. Additional exercises that emphasized overall strength encompassed shoulder and arm movements, as well as abdominal and back extension exercises. Participants were encouraged to execute the strength training exercises depicted in the program's takeout pamphlets twice per week. Furthermore, participants will be motivated to engage in aerobic leisure activities for a duration of two hours per week, including bicycling, walking, running, swimming, or participating in various sports. | Other | – |
Primary outcome
Change of severity of the Metabolic Syndrome components
Time frame: 3 months
The change in the severity of the metabolic syndrome components following 3-months obesity control intervention in comparison with the baseline. All participants were assessed for the five criteria of metabolic syndrome (according to IDF\&AHA): Metabolic syndrome was diagnosed if study Participants have at least three of the following five items: (1) Central obesity (waist circumference ≥ 102cm in male; ≥ 88 cm in female),(2) Blood pressure ≥130/85 mmhg,(3) Dyslipidemia (TG ≥ 150mg/dl), (4) Dyslipidemia (HDL-C < 40mg/dl in male; < 50mg/dl in female), and(5)Fasting blood glucose ≥ 110mg/dl. The blood pressure of participants in the office setting will be assessed and venous blood samples will be collected in order to assess blood lipids and fasting blood glucose levels. The safety blood profile will be conducted using established methodologies in a qualified laboratory specializing in clinical chemistry.
1 secondary outcome
Work Ability of participants
Time frame: 3 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 10 Jan 2025.
- Results publication: PubMed 28660321Andersen LL, Izquierdo M, Sundstrup E. Overweight and obesity are progressively associated with lower work ability in the general working population: cross-sectional study among 10,000 adults. Int Arch Occup Environ Health. 2017 Nov;90(8):779-787. doi: 10.1007/s00420-017-1240-0. Epub 2017 Jun 28.
- Results publication: PubMed 31840755Guzman M, Zbella E, Alvarez SS, Nguyen JL, Imperial E, Troncale FJ, Holub C, Mallhi AK, VanWyk S. Effect of an intensive lifestyle intervention on the prevalence of metabolic syndrome and its components among overweight and obese adults. J Public Health (Oxf). 2020 Nov 23;42(4):828-838. doi: 10.1093/pubmed/fdz170.
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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.
Rania El sallamy study director
Tanta university faculty of medicine
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 Obesity-related Medical Conditions, run by Tanta University at 1 site in Egypt.
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 2 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: opening soon, as of the sponsor's last update on 10 Jan 2025. 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 Egypt. 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 Noha Elghazally (9054830478, nohaelghazally1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of severity of the Metabolic Syndrome components (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06768892, which also lists 2 linked publications.
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 10 Jan 2025.