Cardiovascular Risk Factor Clinical Trial
Official title:
Breaking up Prolonged Sitting Time in Office Workers With Light-intensity Walking: A Pilot Randomized Controlled Trial
Verified date | April 2019 |
Source | University of Bedfordshire |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Sitting for long uninterrupted periods of time can increase risk of heart disease, diabetes
and early death, even if you take part in the United Kingdom government guidelines for
physical activity of 21/2 hours per week of exercise. Effective interventions to reduce the
risk of these diseases are therefore needed. The aim of this study is to examine the effects
of regularly breaking up sitting time with light intensity treadmill desk walking among
office workers on health markers, sitting time and physical activity. If using a treadmill
desk leads to benefits in these disease risk markers then this could be an effective strategy
to improve employee health in the workplace.
Participants will be randomly assigned to the intervention group or the control group. After
baseline activity and health measures, they will take part in the study for 4 weeks.
Intervention group: Participants will have a treadmill desk placed in their office or a
nearby location and will be asked to walk while working on the treadmill desk continuously
for 20 minutes at a self-selected slow pace each hour for a minimum of 6 hours per shift.
There will be one treadmill desk between 2-3 people.
Control group: Participants will be asked to work as usual at their regular workstation with
no changes in their physical activity and dietary habits.
Sitting time and physical activity will be measured at baseline and during the last week f
the intervention. A range of health and psychological measures will be taken at baseline and
post-intervention.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 30, 2018 |
Est. primary completion date | October 30, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - adults aged 18-65 years who work for shifts lasting = 6 h and spend = 75% of this time sitting at their desk - work a minimum of 3 days per week Exclusion Criteria: - the presence of any known blood borne disease - self-reported diagnosed diabetes - physical activity contraindications - pregnancy - any major injury or illness, tobacco use, or any other health issue that my limit the participant in carrying out the required activity bouts. - any planned absence from their office for more than one week during the 4 week study period. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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University of Bedfordshire |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Workplace sitting time | This will be objectively measured using an activpal thigh worn activity monitor | Baseline and week 4 of intervention | |
Secondary | Change in Workplace stepping | This will be objectively measured using an activpal thigh worn activity monitor | Baseline and week 4 of intervention | |
Secondary | Change in Daily sitting time | This will be objectively measured using an activpal thigh worn activity monitor | Baseline and week 4 of intervention | |
Secondary | Change in Daily physical activity | This will be objectively measured using an activpal thigh worn activity monitor | Baseline and week 4 of intervention | |
Secondary | Change in Sleep quality and quantity | Measured with the Pittsburgh Sleep Quality Index | Baseline and post-intervention (within 1 week after intervention ends) | |
Secondary | Change in Mental-wellbeing | Measured using the Warwick-Edinburgh Mental Well-being Scale. each of the following items is indicated on the following scale: none of the time=1; rarely=2; some of the time=3; often=4; all of the time=5 (5 indicating a better outcome).The total scores are summed. Items: I've been feeling optimistic about the future I've been feeling useful I've been feeling relaxed I've been feeling interested in other people I've had energy to spare I've been dealing with problems well I've been thinking clearly I've been feeling good about myself I've been feeling close to other people I've been feeling confident I've been able to make up my own mind about things I've been feeling loved I've been interested in new things I've been feeling cheerful |
Baseline and post-intervention (within 1 week after intervention ends) | |
Secondary | Change in body mass index (kg/m2) | Calculated with measurement of height and weight | Baseline and post-intervention (within 1 week after intervention ends) | |
Secondary | Change in waist circumference (cm) | Measured with a tape measure at the level of the umbillicus | Baseline and post-intervention (within 1 week after intervention ends) | |
Secondary | Change in blood pressure (mmHg) | Measured using an automated blood pressure monitoring device | Baseline and post-intervention (within 1 week after intervention ends) | |
Secondary | Change in blood glucose (mmol/L) | Measured via finger prick method and analysed using the Cholestech analyser | Baseline and post-intervention (within 1 week after intervention ends) | |
Secondary | Change in triglycerides (mmol/L) | Measured via finger prick method and analysed using the Cholestech analyser | Baseline and post-intervention (within 1 week after intervention ends) | |
Secondary | Change in high-density lipoprotein cholesterol (mmol/L) | Measured via finger prick method and analysed using the Cholestech analyser | Baseline and post-intervention (within 1 week after intervention ends) | |
Secondary | Change in positive and negative affect | Measured using the positive and negative affect scale. Items will be measured on the following scale: very slightly or not at all=1; a little=2; moderately=3; quite a bit=4; extremely=5. The items are: interested distressed excited upset strong guilty scared hostile enthusiastic proud irritable alert ashamed inspired nervous determined attentive jittery active afraid The 10 items for POSITIVE (PA) affect are: attentive, interested, alert, excited, enthusiastic, inspired, proud, determined, strong and active. The 10 items for NEGATIVE (NA) affect are: distressed, upset, hostile, irritable, scared, afraid, ashamed, guilty and nervous, jittery. The scores generated will vary along the scale of 10 - 50, with lower scores indicating low (positive or negative) affect and higher scores indicating high (positive or negative) affect. |
Baseline and post-intervention (within 1 week after intervention ends) | |
Secondary | Change in self-efficacy | Measured using the Self-Efficacy Scale questionnaire (Schwarzer and Renner, 2009) | Baseline and post-intervention (within 1 week after intervention ends) | |
Secondary | Change in job performance | Measured using a single-item 7-point likert scale | Baseline and post-intervention (within 1 week after intervention ends) | |
Secondary | Change in work engagement | Measured using the Utrecht Work Engagement Scale multi-item 7-point likert scale | Baseline and post-intervention (within 1 week after intervention ends) | |
Secondary | Change in musculoskeletal symptoms | Measured using the Sandardised Nordic Questionnaire | Baseline and post-intervention (within 1 week after intervention ends) | |
Secondary | Change in presenteeism | Measured using the 8-item Work Limitations Questionnaire | Baseline and post-intervention (within 1 week after intervention ends) | |
Secondary | Change in quality of life | Measured using the World Health Organization Quality of Life questionnaire | Baseline and post-intervention (within 1 week after intervention ends) | |
Secondary | Change in perceived stress | Measured using the Cohen Perceived Stress likert scale. 10 items are answered on the following scale that refer to the person's thoughts and feelings over the past month: never=1; almost never=2; sometimes=3; fairly often=4; very often=5 The items are in the past month how often have you: been upset because of something that happened unexpectedly felt unable to control the important things in your life felt nervous or stressed felt confident about your ability to handle personal problems felt that things were going your way found that you could not cope with all the things you had to do been able to control irritations in your life that you were on top of things been angry because of things that happened that were outside of your control felt that difficulties were piling up so high that you could not overcome them Positively worded items are reverse scored and the ratings are summed, with higher scores indicating more perceived stress. |
Baseline and post-intervention (within 1 week after intervention ends) | |
Secondary | Change in perceived vigor | Measured using a 12 item likert scale. The scale is: never of almost never=1; very infrequently=2; quite infrequently=3; sometimes=4; quite frequently=5; very frequently=6; always or almost always=7. The items are based on how often have you felt this way at work? There are three subscales of the Shirom-Melamed Vigor Measure. The three subscales are: Physical Strength; Emotional Energy; and Cognitive Liveliness. Higher scores indicate better outcomes. |
Baseline and post-intervention (within 1 week after intervention ends) |
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