NCT03560544

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 18, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

June 25, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

October 10, 2018

Status Verified

October 1, 2018

Enrollment Period

3 months

First QC Date

April 11, 2018

Last Update Submit

October 9, 2018

Conditions

Sedentary Lifestyle

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (15)

  • Absenteeism

    Change from baseline absenteeism at 8 weeks

  • Presenteeism

    Change from baseline presenteeism at 8 weeks

  • Ecological momentary assessment (EMA)

    Eight weeks

  • Height

    Once at baseline

  • Change in weight

    Change from baseline weight at 8 weeks

  • +10 more secondary outcomes

Study Arms (2)

Breaking up sitting time

EXPERIMENTAL

A behaviour-change intervention to break up prolonged sitting in the workplace

Behavioral: Breaking up sitting

Control

NO INTERVENTION

The participants in the control group will continue their daily activities as normal without any form of information about the intervention.

Interventions

Breaking up sittingBEHAVIORAL

A three-part behaviour change intervention, including: 1. Supportive organisational culture and knowledge of consequence of prolonged sitting 2. Environmental Modification 3. Behavioural Changes

Breaking up sitting time

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bedford Borough Council

Bedford, Bedfordshire, MK42 9AP, United Kingdom

Location

University of Bedfordshire

Luton, Bedfordshire, LU1 3JU, United Kingdom

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Health and Ageing

Study Record Dates

First Submitted

April 11, 2018

First Posted

June 18, 2018

Study Start

June 25, 2018

Primary Completion

September 30, 2018

Study Completion

December 31, 2018

Last Updated

October 10, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(2)