Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000391471
Ethics application status
Approved
Date submitted
17/01/2025
Date registered
1/05/2025
Date last updated
1/05/2025
Date data sharing statement initially provided
1/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of a workplace Web-Based Intervention in improving lifestyle and productivity
Scientific title
Effectiveness of a workplace Web-Based Intervention in improving Lifestyle, Health, and Productivity among Beauty Consultants
Secondary ID [1] 313734 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lifestyle 336349 0
Condition category
Condition code
Diet and Nutrition 332882 332882 0 0
Obesity
Cardiovascular 333051 333051 0 0
Normal development and function of the cardiovascular system
Physical Medicine / Rehabilitation 333052 333052 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group (IG) will undergo a 12-week program during which they will be required to complete two weekly strength training sessions and watch a short educational video on healthy lifestyle habits through a web platform. Each training session will be separated for at least 48 hours from the next session.
The educational videos, each averaging 20 minutes, will cover various topics from a holistic and comprehensive perspective, presenting scientific literature in a practical and easily understandable manner. The topics will include: the impact of lifestyle on health; physical exercise as medicine; cardiometabolic risk and lifestyle; body composition and health; practical implementation and health effects of the Mediterranean diet; unhealthy foods to avoid; back pain and ergonomics; stress and sleep quality, and their effects on health; and strategies for maintaining good lifestyle habits in the long term.

The strength training sessions will follow this structure: after a dynamic warm-up involving mobility exercises, participants will perform two strength circuits. The first circuit will focus on the core (example: planks, bridge), while the second will target other major muscle groups (example: squats, push-ups). Both circuits will be completed three times, each containing 4-5 exercises with 10-15 repetitions performed at an intensity of 7-8 on the Borg Perceived Exertion Scale (RPE). Each session will last for 50 minutes approximatively.

The exercises will be designed to be performed without equipment, using body weight as resistance or with a simple elastic band. This flexibility will allow participants to complete the sessions at any time and place, thereby promoting adherence to the program.

After completing the two strength circuits, participants will engage in a 10-minute cooldown, which will include flexibility exercises.

Throughout the 12 weeks, each participant will be assigned a qualified trainer who will contact them weekly to check if any modifications are needed, to provide exercise variations, and to help adjust the exercise intensity appropriately. Additionally, the web platform will track participants' completion of the training sessions and educational videos.

Participants will be instructed following exercise videos on the web platform.
Intervention code [1] 330334 0
Lifestyle
Comparator / control treatment
During these 12 weeks, the control group (CG) will not receive any intervention.
Control group
Active

Outcomes
Primary outcome [1] 340412 0
Work productivity
Timepoint [1] 340412 0
Before starting the intervention program (T1), and just after completing the 12-week intervention (T2).
Secondary outcome [1] 443978 0
Perceived stress
Timepoint [1] 443978 0
Before starting the intervention program (T1), and just after completing the 12-week intervention (T2).
Secondary outcome [2] 443979 0
Sleep quality
Timepoint [2] 443979 0
Before starting the intervention program (T1), and just after completing the 12-week intervention (T2)
Secondary outcome [3] 443980 0
Back pain
Timepoint [3] 443980 0
before starting the intervention program (T1), and just after completing the 12-week intervention (T2)
Secondary outcome [4] 443981 0
Functional lower extremity strength
Timepoint [4] 443981 0
Before starting the intervention program (T1), and just after completing the 12-week intervention (T2)
Secondary outcome [5] 443982 0
Adherence to the MedDiet
Timepoint [5] 443982 0
Before starting the intervention program (T1), and just after completing the 12-week intervention (T2)
Secondary outcome [6] 443983 0
Physical activity levels and sedentary behavior. This will be assessed as a composite outcome
Timepoint [6] 443983 0
Before starting the intervention program (T1), and just after completing the 12-week intervention (T2)

Eligibility
Key inclusion criteria
The inclusion criteria required participants to be employees aged 18-65 years.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria included: (1) a diagnosed chronic disease contraindicating physical exercise as per medical advice; (2) musculoskeletal injuries preventing physical activity; (3) high cardiovascular risk as identified by the PAR-Q.

The PAR-Q assesses the presence of risk factors during moderate physical activity and evaluates family history and disease severity. If a participant responds affirmatively to one or more questions, he should undergo a comprehensive follow-up with medical inquiries and consult a physician before starting physical activity

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2025
Actual
Date of last participant enrolment
Anticipated
6/06/2025
Actual
Date of last data collection
Anticipated
1/09/2025
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment outside Australia
Country [1] 26829 0
Spain
State/province [1] 26829 0

Funding & Sponsors
Funding source category [1] 318202 0
Self funded/Unfunded
Name [1] 318202 0
Unfunded
Country [1] 318202 0
Primary sponsor type
Individual
Name
Guillermo García-Pérez-de-Sevilla - Universidad Europea de Madrid
Address
Country
Spain
Secondary sponsor category [1] 320592 0
None
Name [1] 320592 0
Address [1] 320592 0
Country [1] 320592 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316853 0
Research Ethics Committee of Universidad Rey Juan Carlos
Ethics committee address [1] 316853 0
Ethics committee country [1] 316853 0
Spain
Date submitted for ethics approval [1] 316853 0
01/10/2022
Approval date [1] 316853 0
02/02/2023
Ethics approval number [1] 316853 0
1001202301923

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 139206 0
Dr Guillermo García-Pérez-de-Sevilla
Address 139206 0
Universidad Europea de Madrid. Calle Tajo s/n 28670 Villaviciosa de Odón
Country 139206 0
Spain
Phone 139206 0
+34629207357
Fax 139206 0
Email 139206 0
[email protected]
Contact person for public queries
Name 139207 0
Guillermo García-Pérez-de-Sevilla
Address 139207 0
Universidad Europea de Madrid. Calle Tajo s/n 28670 Villaviciosa de Odón
Country 139207 0
Spain
Phone 139207 0
+34629207357
Fax 139207 0
Email 139207 0
[email protected]
Contact person for scientific queries
Name 139208 0
Guillermo García-Pérez-de-Sevilla
Address 139208 0
Universidad Europea de Madrid. Calle Tajo s/n 28670 Villaviciosa de Odón
Country 139208 0
Spain
Phone 139208 0
+34629207357
Fax 139208 0
Email 139208 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.