Metabolic Syndrome Clinical Trial
Official title:
A-REST (Activity to Reduce Excessive Sitting Time): a Cluster Randomised Controlled Feasibility Trial to Reduce Prolonged Sitting in Police Staff
Verified date | November 2020 |
Source | University of Bedfordshire |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary aim of this study is to assess the feasibility of an intervention to reduce and break up prolonged sitting time in full-time police staff. The secondary aims of this study are to assess preliminary effects on patterns of sedentary behaviour (number of breaks, number of prolonged sitting bouts, average duration of prolonged sitting bouts, and total prolonged sitting duration), additional measures of sedentary behaviour (total sitting time, standing, and stepping), cardiometabolic risk markers, physiological stress (cortisol levels), physical health (self-report and postural stability), psychological wellbeing and mood, work stress (self-reported), and work performance (job satisfaction and productivity).
Status | Completed |
Enrollment | 24 |
Est. completion date | December 20, 2019 |
Est. primary completion date | December 20, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University of Bedfordfordshire | Bedford | Bedfordshire |
Lead Sponsor | Collaborator |
---|---|
University of Bedfordshire |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility - Adherence: Drop-out rates in control and intervention group | Analyses of drop-out rates (%) in control and intervention group. | From recruitment (typically 4 weeks prior to baseline) up to study completion (typically 12 weeks) | |
Primary | Feasibility - Acceptability: Perceptions of the intervention | Asking participants' to qualitatively reflect on the intervention via semi-structured interview. | At week 11 | |
Secondary | Change in the number of breaks (sit-stand transitions) from sedentary time per hour (workplace and daily) | Participants will wear a thigh-based accelerometer/inclinometer (ActivPAL3), which provides a well established measure of sit-stand transitions. | This measure will be assessed at baseline and 10 weeks. At each time point the accelerometer will be worn for 7 days. | |
Secondary | Change in sitting time accrued in prolonged bouts (= 30 minutes) (workplace and daily) | Participants will wear a thigh-based accelerometer/inclinometer (ActivPAL3), which provides a well established measure of sitting time accrued in prolonged bouts (= 30 minutes). | This measure will be assessed at baseline and 10 weeks. At each time point the accelerometer will be worn for 7 days. | |
Secondary | Change in the average duration (minutes) of prolonged sitting bouts (= 30 minutes) (workplace and daily) | 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). | This measure will be assessed at baseline and 10 weeks. At each time point the accelerometer will be worn for 7 days. | |
Secondary | Change in the number of prolonged sitting bouts (= 30 minutes) (workplace and daily) | Participants will wear a thigh-based accelerometer/inclinometer (ActivPAL3), which provides a well established measure of the number of prolonged sitting bouts (= 30 minutes). | This measure will be assessed at baseline and 10 weeks. At each time point the accelerometer will be worn for 7 days. | |
Secondary | Change in the total duration (minutes) of sitting time (workplace and daily) | Participants will wear a thigh-based accelerometer/inclinometer (ActivPAL3), which provides a well established measure of sitting time. | This measure will be assessed at baseline and 10 weeks. At each time point the accelerometer will be worn for 7 days. | |
Secondary | Change in step count (workplace and daily) | Participants will wear a thigh-based accelerometer/inclinometer (ActivPAL3), which provides a well established measure of step count. | This measure will be assessed at baseline and 10 weeks. At each time point the accelerometer will be worn for 7 days. | |
Secondary | Change in total stepping time (in minutes) (workplace and daily) | Participants will wear a thigh-based accelerometer/inclinometer (ActivPAL3), which provides a well established measure of total stepping time (in minutes). | This measure will be assessed at baseline and 10 weeks. At each time point the accelerometer will be worn for 7 days. | |
Secondary | Change in total standing time (in minutes) (workplace and daily) | Participants will wear a thigh-based accelerometer/inclinometer (ActivPAL3), which provides a well established measure of total standing time (in minutes). | This measure will be assessed at baseline and 10 weeks. At each time point the accelerometer will be worn for 7 days. | |
Secondary | Weight (kg) | Changes in weight via Tanita scale. | Baseline and at week 11 | |
Secondary | Body mass index (BMI) | Changes in BMI will be computed by dividing participants' weight (in kilograms) by their height (in metres) squared. | Baseline and at week 11 | |
Secondary | Waist circumference (cm) | Changes in waist circumference will be assessed by tape measure. | Baseline and at week 11 | |
Secondary | Body fat % | Changes in body fat percentage will be assessed via a bioelectric impedance spectroscopy device. | Baseline and at week 11 | |
Secondary | Body fat mass (kg) | Changes in body fat mass via a bioelectric impedance spectroscopy device. | Baseline and at week 11 | |
Secondary | Lean body mass (kg) | Changes in lean body mass via a bioelectric impedance spectroscopy device. | Baseline and at week 11 | |
Secondary | Blood pressure (mmHg) | Changes in blood pressure measured via electronic sphygmomanometer. | Baseline and at week 11 | |
Secondary | Fasted blood cholesterol (mg/dL) | Changes in total, high density lipoprotein (HDL), and low density lipoprotein (LDL) cholesterol measured via fasting blood tests using a Cholestech machine. | Baseline and at week 11 | |
Secondary | Fasted blood triglycerides (mg/dL) | Changes in triglycerides measured via fasting blood tests using a Cholestech machine. | Baseline and at week 11 | |
Secondary | Fasted blood glucose (mg/dL) | Changes in glucose levels measured via fasting blood tests using a Cholestech machine. | Baseline and at week 11 | |
Secondary | Salivary cortisol (nmol/L) | 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. | Baseline and at week 11. At each time point saliva samples will be collected at 7 time points over the course of one day. | |
Secondary | Nordic musculoskeletal questionnaire | 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. | Baseline and at week 11 | |
Secondary | Postural sway velocity (mm/s) | 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). | Baseline and at week 11 | |
Secondary | Postural sway range (mm) | 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). | Baseline and at week 11 | |
Secondary | International Physical Activity Questionnaire short form (IPAQ) | 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. | Baseline and at week 11 | |
Secondary | Marshall sitting questionnaire | 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. | Baseline and at week 11 | |
Secondary | Warwick-Edinburgh mental well-being scale (WEMWBS) | 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". | Baseline and at week 11 | |
Secondary | Positive and negative affect schedule (PANAS) | 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 | |
Secondary | Operational police stress questionnaire (PSQ-Op) | 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. | Baseline and at week 11 | |
Secondary | Organisational police stress questionnaire (PSQ-Org) | 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. | Baseline and at week 11 | |
Secondary | Job satisfaction | 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. | Baseline and at week 11 | |
Secondary | Job performance | 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. | Baseline and at week 11 |
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