NCT07603141

Brief Summary

The main objective of this study is to investigate the efficacy of a 6-month workplace combined (exercise and nutrition) intervention in obese office workers, using a randomized controlled study. An additional objective of this study is to evaluate the individual responses per participant following the program.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

May 11, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

June 30, 2026

Expected
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2026

7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

1 month

First QC Date

May 11, 2026

Last Update Submit

May 17, 2026

Conditions

Keywords

occupational setting; wellness; physical activity; functional capacity; dietary habits; hy-dration

Outcome Measures

Primary Outcomes (11)

  • Body fat

    Body fat (BF): BF% will be assessed using the bioelectrical impedance method (Maltron 900).

    Baseline and 6 months

  • Body circumferences

    The waist and hip circumferences will be measured using an ergonomic circumference measuring tape (Seca 201).

    Baseline and 6 months

  • Blood pressure

    Systolic and diastolic blood pressure will be measured, using an electronic upper arm blood pressure monitor (A\&D-UA-851).

    Baseline and 6 months

  • Respiratory function

    Forced vital capacity (FVC) and forced expiratory volume in 1 s (FEV1) will be measured, using a portable spirometer (Micro, Medical, Micro).

    Baseline and 6 months

  • Lipidemic profile

    A blood sample will be obtained after overnight fasting (12 h), as previously described \[37\]. Total cholesterol, high-density lipoprotein (HDL) and triglycerides will be determined using a biochemical analyzer (Clinical Chemistry Analyzer Z 1145; Zafiropoulos Diagnostica S.A., Koropi, Greece), and low-density lipoprotein (LDL) will be calculated using the Friedewald equation.

    Baseline and 6 months

  • Lower body flexibility:

    The sit-and-reach test will be performed using a Flex-Tester box (Novel Products Inc., Rockton, IL, USA).

    Baseline and 6 months

  • Static balance

    The single-limb stance test (with eyes opened) was performed, as previously described by Rinne et al.

    Baseline and 6 months

  • Dynamic balance:

    The timed up-and-go test was performed, as previously described by Rikli and Jones.

    Baseline and 6 months

  • Handgrip strength

    Maximal isometric handgrip strength will be assessed using a portable hydraulic dynamometer (Jamar 5030J1, Horsham, USA).

    Baseline and 6 months

  • Aerobic capacity:

    The YMCA 3 min step test was used, which will be performed following the metronome cadence (96 beats per minute; 4 steps per cycle). The participants' HR will be measured 1 min following the termination of the step test.

    Baseline and 6 months

  • Adherence to the Mediterranean diet

    The adherence to the Mediterranean diet will be assessed before and after the 6-month period using the specific Mediterranean Diet Score (range of total score: 0-55) \[34-35\]. The MedDietScore measures the weekly consumption of the following 9 food groups: non-refined cereals (whole grain bread and pasta, brown rice, etc), fruit, vegetables, legumes, potatoes, fish, red meat and products, poultry, full fat dairy products (like cheese, yoghurt, milk), as well as olive oil and alcohol intake \[35\].

    Baseline and 6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

The IG will participate in a daily supervised 6-month workplace program (during working hours) including: a. exercise (flexibility, balance, strength, aerobic), and b. counseling and educational activities for healthy diet and hydration.

Other: Workplace combined (exercise and nutrition) intervention

Control group

NO INTERVENTION

The CG did not participate in any intervention.

Interventions

The IG will participate in a supervised 6-month combined intervention program (exercise and nutrition), which will take place inside the workplace settings during working hours. In more detail, the IG will participate, every working day (5 days/week), in a 6-month supervised combined chair-based exercise program (120 training sessions; 25-40 min/day), including chair based seated and chair-assisted standing exercises to improve flexibility, balance, strength and aerobic capacity. Except exercise, the intervention program consisted of weekly counseling and educational activities in healthy diet and proper hydration using presentations, leaflets, individual and group sessions with nutritionist, use of applications for proper hydration, use of goal-setting cards for healthy options

Intervention group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • In more detail, the participants: 1) should have at least 8 h per day in the office, 2) should have BMI value ≥ 30 kg/m2, 3) should not have chronic diseases (physical or mental), 4) should not use any medication, 5) should not have injuries (in lower or upper body) the last 6 months and 6) should not participate in organized exercise programs or nutrition intervention during the last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Education and Sports Science, University of Thessaly

Trikala, Greece, 42100, Greece

Location

MeSH Terms

Conditions

ObesityMotor ActivityFeeding Behavior

Interventions

ExerciseNutritional StatusMethods

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorBehavior, Animal

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation CharacteristicsInvestigative Techniques

Study Officials

  • Konstantina Karatrantou

    University of Thessaly

    PRINCIPAL INVESTIGATOR
  • Vassilis Gerodimos

    University of Thessaly

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Proffessor at Department of Physical Education and Sports Science of the University of Thessaly

Study Record Dates

First Submitted

May 11, 2026

First Posted

May 22, 2026

Study Start (Estimated)

June 30, 2026

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

February 28, 2027

Last Updated

May 22, 2026

Record last verified: 2026-05

Locations