- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04053686
An Intervention to Reduce Prolonged Sitting in Police Staff
A-REST (Activity to Reduce Excessive Sitting Time): a Cluster Randomised Controlled Feasibility Trial to Reduce Prolonged Sitting in Police Staff
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Prolonged sedentary behaviour is associated with a higher incidence of cardiovascular disease and type 2 diabetes. A large proportion of daily sedentary time (sitting) occurs in the workplace. On average, full time office workers spend upwards of 70% of their working day seated with the majority of this time accumulated in sitting bouts ≥ 20 minutes. A recent cross-sectional investigation into the occupational characteristics of over 5,000 British police force employees reported at least 30% identifying as having mainly office-based duties. When trying to reduce prolonged sitting in the workplace, one of the most effective strategies is the use of multi-component interventions. At the present time, sedentary workplace intervention studies in the police are limited.
The primary aim of this study is to assess the feasibility of an intervention to reduce and break up prolonged sitting time at work in full-time police staff. The secondary aims of this study are to assess preliminary effects on sedentary behaviour, cardiometabolic risk markers, physiological stress, physical health, psychological wellbeing and mood, work stress, and work performance.
This has a single-arm, pre-post study design. Participants will receive a multi-component intervention to break up and reduce prolonged sitting including: a presentation/workshop, electronic support, minor environmental modifications, organisational support, and team competition. Assessments will take place at baseline and post-intervention (week 10).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bedfordshire
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Bedford, Bedfordshire, United Kingdom, MK41 9EA
- University of Bedfordfordshire
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ≥ 0.6 Full Time Equivalent (FTE) work hours
- Ambulatory
- Predominantly desk-based (spend on average ≥ 5-h/day seated at work by self-report)
- Own a smartphone, with ability to keep phone with them during work hours
Exclusion Criteria:
- Planned absence of two weeks or more during the intervention period
- Work part time (< 0.6 FTE)
- Health contraindications to standing and walking
- Planned relocation to another site, office or workplace
- Have personal access to an active workstation (sit-stand desk, seat cycle, treadmill desk or similar)
- Participating simultaneously in another workplace intervention (for sedentary behaviour, physical activity, diet, lifestyle, or combination thereof)
- Health contraindications to postural stability testing (e.g., injury to the lower extremities in the past six months, dizziness, or epilepsy)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
The intervention group will aim to regularly break up participants' prolonged sitting time with three-minute incidental movement breaks every half hour at work.
Support for behaviour change will include a lecture/workshop, electronic prompts, break logging, team competition, health champions, and email support.
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3-min breaks every half hour at work
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility - Adherence: Drop-out rates in control and intervention group
Time Frame: From recruitment (typically 4 weeks prior to baseline) up to study completion (typically 12 weeks)
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Analyses of drop-out rates (%) in control and intervention group.
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From recruitment (typically 4 weeks prior to baseline) up to study completion (typically 12 weeks)
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Feasibility - Acceptability: Perceptions of the intervention
Time Frame: At week 11
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Asking participants' to qualitatively reflect on the intervention via semi-structured interview.
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At week 11
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the number of breaks (sit-stand transitions) from sedentary time per hour (workplace and daily)
Time Frame: This measure will be assessed at baseline and 10 weeks. At each time point the accelerometer will be worn for 7 days.
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Participants will wear a thigh-based accelerometer/inclinometer (ActivPAL3), which provides a well established measure of sit-stand transitions.
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This measure will be assessed at baseline and 10 weeks. At each time point the accelerometer will be worn for 7 days.
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Change in sitting time accrued in prolonged bouts (≥ 30 minutes) (workplace and daily)
Time Frame: This measure will be assessed at baseline and 10 weeks. At each time point the accelerometer will be worn for 7 days.
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Participants will wear a thigh-based accelerometer/inclinometer (ActivPAL3), which provides a well established measure of sitting time accrued in prolonged bouts (≥ 30 minutes).
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This measure will be assessed at baseline and 10 weeks. At each time point the accelerometer will be worn for 7 days.
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Change in the average duration (minutes) of prolonged sitting bouts (≥ 30 minutes) (workplace and daily)
Time Frame: This measure will be assessed at baseline and 10 weeks. At each time point the accelerometer will be worn for 7 days.
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Participants will wear a thigh-based accelerometer/inclinometer (ActivPAL3), which provides a well established measure of the average duration (minutes) of prolonged sitting bouts (≥ 30 minutes).
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This measure will be assessed at baseline and 10 weeks. At each time point the accelerometer will be worn for 7 days.
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Change in the number of prolonged sitting bouts (≥ 30 minutes) (workplace and daily)
Time Frame: This measure will be assessed at baseline and 10 weeks. At each time point the accelerometer will be worn for 7 days.
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Participants will wear a thigh-based accelerometer/inclinometer (ActivPAL3), which provides a well established measure of the number of prolonged sitting bouts (≥ 30 minutes).
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This measure will be assessed at baseline and 10 weeks. At each time point the accelerometer will be worn for 7 days.
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Change in the total duration (minutes) of sitting time (workplace and daily)
Time Frame: This measure will be assessed at baseline and 10 weeks. At each time point the accelerometer will be worn for 7 days.
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Participants will wear a thigh-based accelerometer/inclinometer (ActivPAL3), which provides a well established measure of sitting time.
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This measure will be assessed at baseline and 10 weeks. At each time point the accelerometer will be worn for 7 days.
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Change in step count (workplace and daily)
Time Frame: This measure will be assessed at baseline and 10 weeks. At each time point the accelerometer will be worn for 7 days.
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Participants will wear a thigh-based accelerometer/inclinometer (ActivPAL3), which provides a well established measure of step count.
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This measure will be assessed at baseline and 10 weeks. At each time point the accelerometer will be worn for 7 days.
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Change in total stepping time (in minutes) (workplace and daily)
Time Frame: This measure will be assessed at baseline and 10 weeks. At each time point the accelerometer will be worn for 7 days.
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Participants will wear a thigh-based accelerometer/inclinometer (ActivPAL3), which provides a well established measure of total stepping time (in minutes).
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This measure will be assessed at baseline and 10 weeks. At each time point the accelerometer will be worn for 7 days.
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Change in total standing time (in minutes) (workplace and daily)
Time Frame: This measure will be assessed at baseline and 10 weeks. At each time point the accelerometer will be worn for 7 days.
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Participants will wear a thigh-based accelerometer/inclinometer (ActivPAL3), which provides a well established measure of total standing time (in minutes).
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This measure will be assessed at baseline and 10 weeks. At each time point the accelerometer will be worn for 7 days.
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Weight (kg)
Time Frame: Baseline and at week 11
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Changes in weight via Tanita scale.
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Baseline and at week 11
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Body mass index (BMI)
Time Frame: Baseline and at week 11
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Changes in BMI will be computed by dividing participants' weight (in kilograms) by their height (in metres) squared.
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Baseline and at week 11
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Waist circumference (cm)
Time Frame: Baseline and at week 11
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Changes in waist circumference will be assessed by tape measure.
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Baseline and at week 11
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Body fat %
Time Frame: Baseline and at week 11
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Changes in body fat percentage will be assessed via a bioelectric impedance spectroscopy device.
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Baseline and at week 11
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Body fat mass (kg)
Time Frame: Baseline and at week 11
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Changes in body fat mass via a bioelectric impedance spectroscopy device.
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Baseline and at week 11
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Lean body mass (kg)
Time Frame: Baseline and at week 11
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Changes in lean body mass via a bioelectric impedance spectroscopy device.
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Baseline and at week 11
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Blood pressure (mmHg)
Time Frame: Baseline and at week 11
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Changes in blood pressure measured via electronic sphygmomanometer.
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Baseline and at week 11
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Fasted blood cholesterol (mg/dL)
Time Frame: Baseline and at week 11
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Changes in total, high density lipoprotein (HDL), and low density lipoprotein (LDL) cholesterol measured via fasting blood tests using a Cholestech machine.
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Baseline and at week 11
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Fasted blood triglycerides (mg/dL)
Time Frame: Baseline and at week 11
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Changes in triglycerides measured via fasting blood tests using a Cholestech machine.
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Baseline and at week 11
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Fasted blood glucose (mg/dL)
Time Frame: Baseline and at week 11
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Changes in glucose levels measured via fasting blood tests using a Cholestech machine.
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Baseline and at week 11
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Salivary cortisol (nmol/L)
Time Frame: Baseline and at week 11. At each time point saliva samples will be collected at 7 time points over the course of one day.
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Changes in the cortisol awakening response and diurnal cortisol levels will be assessed via saliva samples (provided by chewing on a cotton swab for 60secs) collected seven times over the course of one day.
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Baseline and at week 11. At each time point saliva samples will be collected at 7 time points over the course of one day.
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Nordic musculoskeletal questionnaire
Time Frame: Baseline and at week 11
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The Nordic musculoskeletal questionnaire is comprised of 40 forced-choice questions pertaining to low back, neck, shoulder and general physical complaints most often experienced in the work setting.
A visual diagram aids the viewer by labelling the nine regions of the body referred to in the questionnaire.
Acceptable reliability for this tool has been demonstrated.
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Baseline and at week 11
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Postural sway velocity (mm/s)
Time Frame: Baseline and at week 11
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Change in postural sway velocity (bipedal-eyes-open, bipedal-eyes-closed, unipedal-eyes-open, unipedal-eyes-closed) will be evaluated via dynamic plantar pressure sensor (RS Footscan).
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Baseline and at week 11
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Postural sway range (mm)
Time Frame: Baseline and at week 11
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Change in postural sway range (bipedal-eyes-open, bipedal-eyes-closed, unipedal-eyes-open, unipedal-eyes-closed) will be evaluated via dynamic plantar pressure sensor (RS Footscan).
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Baseline and at week 11
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International Physical Activity Questionnaire short form (IPAQ)
Time Frame: Baseline and at week 11
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Changes in self-reported physical activity and total sitting time.
The International Physical Activity Questionnaire short form (IPAQ) measures self-reported physical activity and sitting time in the last seven days.
Participants are asked to report frequency of participation (0-7 days) and duration of activity on one of those days (in hours and minutes).
The IPAQ has demonstrated acceptable reliability and validity in measuring activity in the last seven days.
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Baseline and at week 11
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Marshall sitting questionnaire
Time Frame: Baseline and at week 11
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The Marshall sitting questionnaire has five questions that measure self-reported domain-specific sitting time (hours and minutes) on weekend days and weekdays.
This questionnaire has good reliability and validity for sitting time on weekdays and weekend days.
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Baseline and at week 11
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Warwick-Edinburgh mental well-being scale (WEMWBS)
Time Frame: Baseline and at week 11
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The Warwick-Edinburgh mental well-being scale (WEMWBS) is a 14-item questionnaire used to assess various aspects of positive mental health (e.g., "I've been feeling optimistic about the future").
Participants are asked to rate their experience of each wellbeing statement between 1 and 5 (1 = none of the time and 5 = all of the time).
Item scores are then combined to provide a total score (between 14 - 70).
The higher the score the better the overall mental wellbeing.
For intervention purposes, a change in the total score of 3-8 points between two time points may be considered a "meaningful change".
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Baseline and at week 11
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Positive and negative affect schedule (PANAS)
Time Frame: Baseline and at week 11
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Changes in self-reported mood via the positive and negative affect schedule (PANAS) consisting of two 10-item subscales to measure positive and negative affect (i.e., mood). A number of words that describe different feelings and emotions (e.g., "interested", "distressed", "excited") are presented and participants are asked to indicate on a 5-point scale to what extent over the past week they have felt these feelings/emotions (1 = very slightly or not at all and 5 = extremely). These scales are internally consistent with very good convergent and discriminant correlations. Negative Affect subscale Item scores on the negative affect scale are then combined to provide a total score (between 10 - 50). The higher the score the more negative emotions experienced. Positive Affect subscale Item scores on the positive affect scale are then combined to provide a total score (between 10 - 50). The higher the score the more positive emotions experienced. |
Baseline and at week 11
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Operational police stress questionnaire (PSQ-Op)
Time Frame: Baseline and at week 11
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Changes in ratings of 20 operational stressors for police (PSQ-Org).
Participants will be asked to rate items on "how much stress it has caused you over the past 6 months" using a 7-point Likert scale (1 = no stress at all and 7 = a lot of stress).
Item scores are then combined to provide a total score (between 20 - 140).
The higher the score the worse the stress level.
This instrument has demonstrated acceptable reliability and validity for measuring police-specific occupational stressors.
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Baseline and at week 11
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Organisational police stress questionnaire (PSQ-Org)
Time Frame: Baseline and at week 11
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Changes in ratings of 20 organisational stressors for police (PSQ-Org).
Participants will be asked to rate items on "how much stress it has caused you over the past 6 months" using a 7-point Likert scale (1 = no stress at all and 7 = a lot of stress).
Item scores are then combined to provide a total score (between 20 - 140).
The higher the score the worse the stress level.
This instrument has demonstrated acceptable reliability and validity for measuring police-specific occupational stressors.
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Baseline and at week 11
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Job satisfaction
Time Frame: Baseline and at week 11
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Changes in self-reported job satisfaction and will be evaluated via a single-item questionnaire ("How satisfied are you with your job in general?") assessed on a 7-point Likert scale (1 = dissatisfied and 7 = extremely satisfied).
A higher score represents more satisfaction with one's job.
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Baseline and at week 11
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Job performance
Time Frame: Baseline and at week 11
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Changes in self-reported job performance will be evaluated via a single-item questionnaire ("How well do you think you have performed in your job recently?")
with a 7-point Likert scale (1 = very poorly and 7 = extremely well).
A higher score represents a more positive assessment of job performance.
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Baseline and at week 11
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daniel Bailey, PhD, University of Bedfordshire
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019ISPAR008
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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