The Effect of Breaking up Sitting in the Workplace on Cardiometabolic Risk and Worker Productivity

Sedentary Lifestyle Clinical Trial

Official title:

Pilot Study of a Tailored Intervention to Break up Sitting in the Workplace on Cardiometabolic Risk and Worker Productivity

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03560544
• Other study ID #: IHREC836
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 25, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: October 2018
• Source: University of Bedfordshire
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This pilot randomized controlled trial (RCT) will examine the effect of a tailored workplace intervention based on interrupting sitting on work productivity, well-being and cardio-metabolic risk in office workers. The experimental group in the 8-week intervention will be prompted to alternate between sitting and standing while working. The ratio between sitting and standing will begin at 3:1 (two hours per day in an eight-hour day) and increase to 1:1 (four hours per day in an eight-hour day) by the end of the second week of the eight-week intervention.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 46
• Est. completion date: December 31, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Full-time office employees from any ethnic background, PC/Android phone users, and recruited from two different work sites.

Exclusion Criteria:

• Pregnancy

• History of musculoskeletal complaint

• Non-ambulatory

• Having a planned holiday that would mean they would not be at work for more than two weeks during the 8-week intervention period.

Related Conditions & MeSH terms

• Sedentary Lifestyle

Intervention

Behavioral:
• Breaking up sitting
A three-part behaviour change intervention, including: Supportive organisational culture and knowledge of consequence of prolonged sitting Environmental Modification Behavioural Changes

Locations

Country	Name	City	State
United Kingdom	Bedford Borough Council	Bedford	Bedfordshire
United Kingdom	University of Bedfordshire	Luton	Bedfordshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Bedfordshire

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in sitting time (objective)	Evaluation of change in sitting time in the workplace using wearable accelerometers (ActivPAL3; PAL Technologies Ltd., Glasgow, UK). The ActivPAL will be worn on the right thigh.	Change from baseline sitting time at 8 weeks
Primary	Change in physical activity level (objective)	Evaluation of physical activity time in the workplace using wearable accelerometers (ActivPAL3; PAL Technologies Ltd., Glasgow, UK). The ActivPAL will be worn on the right thigh.	Change from baseline physical activity level at 8 weeks
Primary	Change in sitting time (subjective)	The International Physical Activity Questionnaire (IPAQ) will be used to provide a subjective measure of sitting. The scale provides a measure of reported sitting time in minutes.	Change from baseline sitting time at 8 weeks
Primary	Change in physical activity level (subjective)	The International Physical Activity Questionnaire (IPAQ) will be used to provide a subjective measure of physical activity level. The scale provides a measure of reported sitting time in minutes for each of three types of physical activity (vigorous, moderate, and walking).	Change from baseline physical activity level at 8 weeks
Secondary	Absenteeism	Participants will be asked to respond to questions on the Gaudine and Gregory questionnaire on unsanctioned absence. Self-reported absenteeism will be calculated by adding the number of days reported for all the three questions.	Change from baseline absenteeism at 8 weeks
Secondary	Presenteeism	Presenteeism will be measured using Work Limitations Questionnaire (WLQ). The WLQ requires employees to self-report their level of difficulty (or ability) to perform 25 specific job demands in the last 2 weeks. Answers generated for the 25 items will be grouped into four work limitation scales including Time Management; Physical Demands; Mental/Interpersonal and Output Demands. The scores for each subscale range from 0-100%, with 0 equivalent to no limitation and 100 equivalent to complete limitation.	Change from baseline presenteeism at 8 weeks
Secondary	Ecological momentary assessment (EMA)	Participants will be prompted at random four times between 9am to 5pm from Monday to Friday to complete a short questionnaire which will only take them 60 seconds to complete whilst in sitting position, standing and /or in walking position to enter their level of productivity.	Eight weeks
Secondary	Height	Measurement of height	Once at baseline
Secondary	Change in weight	Measurement of weight	Change from baseline weight at 8 weeks
Secondary	Change in waist circumference	Measurement waist circumference	Change from baseline waist circumference at 8 weeks
Secondary	Blood pressure	Systolic and diastolic blood pressure on the right arm after resting for at least 10 min in a seated position using an automated blood pressure monitor (Omron HEM705 CP, Omron Healthcare UK Limited, Milton Keynes, UK).	Change from baseline blood pressure at 8 weeks
Secondary	Change in fasting total cholesterol	Blood samples will be collected in capillary tubes after an overnight fast using a finger prick method with lancet. Measures of total cholesterol will be made.	Change from baseline fasting total cholesterol at 8 weeks
Secondary	Change in fasting high-density lipoprotein	Blood samples will be collected in capillary tubes after an overnight fast using a finger prick method with lancet. Measures of high-density lipoprotein will be made.	Change from baseline fasting high-density lipoprotein at 8 weeks
Secondary	Change in fasting triglycerides	Blood samples will be collected in capillary tubes after an overnight fast using a finger prick method with lancet. Measures of triglycerides will be made.	Change from baseline fasting triglycerides at 8 weeks
Secondary	Change in fasting blood glucose levels	Blood samples will be collected in capillary tubes after an overnight fast using a finger prick method with lancet. Measures of blood glucose levels will be made.	Change from baseline fasting blood glucose levels at 8 weeks
Secondary	Stress	Cohen Perceived Stress questionnaire will be used to assess perception of stress. It primarily evaluates the unpredictability, uncontrollability and overload of an individual's life.	Change from baseline stress at 8 weeks
Secondary	Mood	The positive and negative affect schedule (PANAS) questionnaire is a 20-item self-report measure of both positive and negative affect.	Change from baseline mood at 8 weeks
Secondary	Mental Wellbeing	The Warwick-Edinburgh Mental well-being Scale will be used to determine whether mental wellbeing changes. This scale has 14 questions, with each question scored from 1-5, giving a total score from 14-70.	Change from baseline mental wellbeing at 8 weeks
Secondary	Self-efficacy	A generalised four-point Likert scale questionnaire will be used to measure the self-efficacy of the participants.	Change from baseline self-efficacy at 8 weeks