Condition category
Not Applicable
Date applied
18/06/2010
Date assigned
18/06/2010
Last edited
29/08/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rebecca Lawton

ORCID ID

Contact details

Woodhouse Lane
Leeds
LS2 9JT
United Kingdom
r.j.lawton@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

3025

Study information

Scientific title

A multicentre randomised interventional prevention trial to develop and evaluate a flexible intervention to promote physical activity within worksites

Acronym

Study hypothesis

The aim of the project was to develop and evaluate a flexible and problem-based intervention to promote physical activity within the workplace that requires no previous experience and could be implemented in any organisation. The intervention targeted mainly employees in low physical activity occupations and produced in an easy-to-implement tool-kit format. The intervention was evaluated in a quasi-experimental design involving 44 worksites across five large organisations. Half the worksites were randomly allocated to the intervention condition (being exposed to the whole intervention) and the remainder were allocated to the control group (who received the awareness component of the intervention only).

Ethics approval

1. Exploratory phase: South Sheffield Research Ethics Committee approved on the 3rd November 2006 (ref: 06/Q2305/159)
2. Main trial: South Sheffield Research Ethics Committee approved on the 11th October 2007 (ref: 07/H1309/90)

Study design

Multicentre randomised interventional prevention trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Public Health Research

Intervention

Awareness, Motivation and Environment (AME):
Using leaflets, self-monitoring tools and team challenges, and thus focused on making changes at the individual level (awareness and motivation) but also encouraged changes in individuals' workplaces (environment) such as providing resources to encourage physical activity, posters to cue people to engage in physical activity and managers who support time spent in physical activity.

The control group received a short lifestyle advice leaflet, covering eating, physical activity, smoking, when they attended for their healthcheck etc.

Participants in the intervention group received a three month intervention delivered via a worksite facilitator and were followed up immediately post-intervention, as well as 3 months and 9 months after the intervention ended.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

International Physical Activity Questionnaire, measured at baseline, immediately post-intervention (3 months), 6 months post-intervention and 9 months post-intervention.

Secondary outcome measures

1. Body mass index (BMI)
2. % body fat
3. Resting heart rate
4. Diastolic and systolic blood pressure

Measured at baseline and again 12 months later.

Overall trial start date

01/10/2006

Overall trial end date

01/10/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Members of staff working at three organisations - a large bus company, a Welsh city council and a large teaching hospital (aged 18 - 65 years, either sex)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 1300

Participant exclusion criteria

Anyone for whom physical activity would be dangerous to health

Recruitment start date

01/10/2006

Recruitment end date

01/10/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Woodhouse Lane
Leeds
LS2 9JT
United Kingdom

Sponsor information

Organisation

University of Leeds (UK)

Sponsor details

Woodhouse Lane
Leeds
LS2 9JT
United Kingdom

Sponsor type

University/education

Website

http://www.leeds.ac.uk

Funders

Funder type

Research organisation

Funder name

BUPA Foundation (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21481265

Publication citations

  1. Results

    McEachan RR, Lawton RJ, Jackson C, Conner M, Meads DM, West RM, Testing a workplace physical activity intervention: a cluster randomized controlled trial., Int J Behav Nutr Phys Act, 2011, 8, 29, doi: 10.1186/1479-5868-8-29.

Additional files

Editorial Notes