NCT06768892

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
154

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 31, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 10, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

January 10, 2025

Status Verified

January 1, 2025

Enrollment Period

3 months

First QC Date

December 31, 2024

Last Update Submit

January 6, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (1)

  • Work Ability of participants

    3 months

Interventions

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.

Also known as: Cognitive Behavioral Therapy (CBT), Physical exercise training

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

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.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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 .

You may qualify if:

  • 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

You may not qualify if:

  • Age lower than 18
  • BMI 24.9 and less

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, Egypt

Location

Related Publications (2)

  • 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.

  • Guzman 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.

MeSH Terms

Conditions

Obesity

Interventions

Diet TherapyCognitive Behavioral TherapyExercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Rania El sallamy

    Tanta university faculty of medicine

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

December 31, 2024

First Posted

January 10, 2025

Study Start

January 1, 2025

Primary Completion

March 31, 2025

Study Completion

April 1, 2025

Last Updated

January 10, 2025

Record last verified: 2025-01

Locations