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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04391270
Other study ID # 12609919
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date July 30, 2023

Study information

Verified date February 2024
Source Hong Kong Baptist University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to examine between-group differences in changes of objectively measured MVPA levels (min/week) among a randomly selected sample of office employees who are physically inactive in Hong Kong.


Description:

Regular participation in moderate-to-vigorous physical activity (MVPA) is related to decreased risk of morbidity and mortality. Among working populations, lack of MVPA may also be a risk factor for absenteeism and presenteeism. Both traditional workplace-based and web-based interventions have been suggested as being effective in promoting participation MVPA, health-related outcomes, and work-related productivity. However, several challenges limit their application in real world contexts. A 'blended' intervention approach combining the two intervention strategies is proposed to overcome these limitations. The proposed intervention aims to utilize the blended approach to increase participation in MVPA, health-related outcomes, and work productivity among inactive workers. Methods: The study will comprise of a three group cluster randomized controlled trial (cluster-RCT), comprising a three-month actual intervention and a nine-month behavioral follow-up period. The three groups will be: a web-based intervention group, a blended intervention group combining the web-based components with face-to-face workshops, and a control group. Physically inactive office employees (N = 141) from will be recruited and randomly assigned to the three groups by cluster randomization. The intervention mapping (IM) framework will be used for selecting and applying effective health behavioural theories and behavioural change techniques (BCTs) to the development, implementation and assessment of the intervention, which will be personally tailored. The primary outcome variable will be objectively measured MVPA using an accelerometer. Secondary outcomes will consist of indices of health including adiposity, blood pressure, blood sugar, blood lipids, self-reported depression, anxiety, stress, and health-related quality of life, and work-related variables including absenteeism and presenteeism.


Recruitment information / eligibility

Status Completed
Enrollment 141
Est. completion date July 30, 2023
Est. primary completion date July 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - physically inactive (do NOT meet the WHO's recommended MVPA levels) - office employees in Hong Kong. Exclusion Criteria: - participants are engaging other ongoing programs involving MVPA promotion - if they report any conditions preventing them from being active.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
blended intervention
A blended intervention group combining the web-based components with face-to-face workshops and posters
web-based intervention
A web-based intervention only referred to the use of internet without traditional face-to-face workshops and posters

Locations

Country Name City State
Hong Kong Department of Sport, Physical Education, and Health Kowloon Tong

Sponsors (1)

Lead Sponsor Collaborator
Hong Kong Baptist University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary moderate-to-vigorous physical activity (MVPA) levels examine between-group differences in changes of objectively measured MVPA levels (min/week) among a randomly selected sample of office employees who are physically inactive in Hong Kong baseline, 13 weeks, 25 weeks
Secondary changes of self-report MVPA levels (min/week) To examine between-group differences in changes of self-reported MVPA levels (min/week) in different domains among the sample. baseline, 13 weeks, 25 weeks
Secondary Height in meters Height will be measured to the nearest 0.1 cm using a stadiometer. baseline, 13 weeks, 25 weeks
Secondary Weight in kilograms Weight will be measured to the nearest 0.1 kg on a calibrated digital balance scale (Seca, max. 200 kg, Germany) with the participants wearing lightweight clothing and no shoes. baseline, 13 weeks, 25 weeks
Secondary Body mass index (BMI, kg/m2) Body mass index (BMI, kg/m2) will be calculated from weight and height. baseline, 13 weeks, 25 weeks
Secondary Waist circumference (cm) Waist circumference (cm) will be measured midway between the lowest rib margin and the top of the iliac crest at the end of gentle expiration baseline, 13 weeks, 25 weeks
Secondary %Body fat %BF will be assessed by a Tanita TBF-410 Body Composition Analyzer (Tanita Corporation, Tokyo, Japan) using foot-to-foot bioelectrical impedance analysis (BIA). baseline, 13 weeks, 25 weeks
Secondary Blood pressure (mmHg) Blood pressure will be measured using the Omron M6 Compact (HEM-7000-E, Omron Healthcare Corporation, Kyoto, Japan) following standard measurement protocols. baseline, 13 weeks, 25 weeks
Secondary Hemoglobin A1C (%) Hemoglobin A1C will be measured using the Reflotron ® Plus system (Roche Diagnostics, F. Hoffmann-La Roche Ltd., Burgess Hill, UK). baseline, 13 weeks, 25 weeks
Secondary Depression, anxiety and stress Depression, anxiety and stress will be measured using the Chinese version of the Depression Anxiety Stress Scale (DASS-21) baseline, 13 weeks, 25 weeks
Secondary Presenteeism It will be assessed using presenteeism questions derived from the WHO's Heath and Work Performance Questionnaire (HPO). baseline, 13 weeks, 25 weeks
Secondary High-density lipoprotein (mmol/L) high-density lipoprotein will be measured using the Reflotron ® Plus system (Roche Diagnostics, F. Hoffmann-La Roche Ltd., Burgess Hill, UK). baseline, 13 weeks, 25 weeks
Secondary Triglyceride (mmol/L) Triglyceride will be measured using the Reflotron ® Plus system (Roche Diagnostics, F. Hoffmann-La Roche Ltd., Burgess Hill, UK). baseline, 13 weeks, 25 weeks