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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03468894
Other study ID # Not yet available
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date March 22, 2018
Est. completion date October 30, 2018

Study information

Verified date April 2019
Source University of Bedfordshire
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Withdrawn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.

Study Design


Intervention

Behavioral:
Treadmill desk walking
See intervention arm description

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Bedfordshire

Outcome

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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