Condition category
Not Applicable
Date applied
02/06/2010
Date assigned
18/06/2010
Last edited
13/03/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
It is well known that being physically active provides a number of health benefits: evidence shows that regular exercise can increase the levels of HDL (‘good’) cholesterol, lower high blood pressure, promote healthy blood sugar levels, and improve fitness and bone density. It can also help to boost the immune system, improve body shape, and improve mood. Yet despite this, most of us are not very active in our everyday lives. We wish to compare the effectiveness of three different approaches to promoting physical activity in staff working on the Cambridge Biomedical Campus at Addenbrooke’s Hospital. We are also interested in what people think of the different approaches. This will help us to develop interventions that are effective in increasing people’s fitness and physical activity, thereby reducing their risk of disease and helping them to feel better.

Who can participate?
Healthy individuals aged 18 –- 65.

What does the study involve?
Participants have a comprehensive health and fitness check where their height, weight and blood pressure are measured and a blood sample (less than 2 tablespoons) is taken to measure cholesterol, glucose levels and nutritional status. Other measurements like body composition and an ECG (heart trace) reading are also taken and two questionnaires are completed, which should take around 20 minutes. In order to measure fitness and physical activity levels participants walk on a treadmill at different speeds and inclines for a maximum of 20 minutes, increasing to a jog for the last few minutes if that is comfortable. Participants only need remain on the treadmill for as long as they feel comfortable. Participants wear a small heart rate monitor on their chest for 6 days after their visit. When they have worn the heart rate monitor for 6 days, they return it. Participants are then randomly allocated into one of four study groups: three groups involve participants monitoring their physical activity daily using different methods, and one group receive no intervention and act as the comparison group.
1. Comparison group –- no intervention
2. Self-monitoring using a paper diary
3. Activity band with web-based feedback graphs
4. Activity band with web-based feedback graphs and support programme
Information on the wearer’'s physical activity levels is uploaded via Bluetooth to the program website where the support and/or feedback programs can also be accessed. Participants in group 4 also receive a set of interactive Bluetooth-enabled weighing scales to enable them to monitor their weight. After 12 weeks all participants return to the MRC Epidemiology Unit testing facilities in the Addenbrooke’s Treatment Centre for a repeat visit, and to return all equipment and diaries. This visit is the same as the first visit, to see if anything has changed over the 12-week period. Participants are asked to wear the heart rate monitor again for 6 days before the visit. After the visit, they complete a final questionnaire and return this by post. Participants may also be invited to take part in a short, audio-recorded interview with a researcher who asks for their own ideas about behaviour related to physical activity, what they thought of the intervention they received, and their experience of taking part in the study, to understand the extent to which behaviour changes might become long-term habits.

What are the possible benefits and risks of participating
Participants are provided you with a comprehensive health report detailing the clinical results from both your assessments, and with their permission their GP is provided with the results of their health and fitness assessments. This will allow participants to discuss their results with their GP, should they wish to do so. The interventions being tested in this study may increase levels of physical activity. Evidence shows that regular exercise can increase the levels of HDL (‘good’) cholesterol, lower high blood pressure, help improve body shape, promote healthy blood sugar levels, promote bone density, boost the immune system and improve mood. Should the interventions encourage participants to adopt a more physically active lifestyle while they are in the study, these benefits rely on them maintaining this lifestyle once the study finishes. The risks of taking part in the study are negligible. Participants will feel a small scratch at the site of blood sampling which will be no more than that usually experienced during the same procedure by a nurse or GP. Trained staff take blood samples and carry out all measurements. Thorough medical checks will be undertaken before participants are asked to go on the treadmill, and if there is any indication of a possible risk the test will be abandoned. The treadmill is fitted with safety handrails and volunteers will be supervised by a trained researcher at all times. The sticky pads that attach the heart rate monitor to the chest have been known to cause itching and a rash in about 10% of people. Participants are provided with information at your visit as to what to do if this happens whilst you are wearing the monitor. If participants increase the amount of physical activity they do, this may increase the risk of sports or exercise-related muscle strains and sprains.

Where is the study run from?
Institute of Public Health (UK)

When is the study starting and how long is it expected to run for?
July 2010 to December 2013

Who is funding the study?
1. Medical Research Council (MRC) (UK)
2. Imperative Health Ltd (UK)
3. National Institute for Health Research (UK)

Who is the main contact?
Prof. Simon Griffin
sjg49@medschl.cam.ac.uk

Trial website

http://bit.ly/thegetmovingstudy

Contact information

Type

Scientific

Primary contact

Prof Simon Griffin

ORCID ID

Contact details

Institute of Public Health
University Forvie Site
Robinson Way
Cambridge
CB2 0SR
United Kingdom
+44 (0) 1223 763431
sjg49@medschl.cam.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomised controlled trial evaluation of the effectiveness of three minimal human contact interventions to promote fitness and physical activity in an occupational health setting

Acronym

Study hypothesis

1. To test the effectiveness of three minimal human contact interventions to increase physical activity and fitness over 12 weeks
2. To investigate the feasibility and acceptability of each intervention
3. To investigate the psychological and cognitive mechanisms through which each intervention works

Ethics approval

Cambridgeshire 2 Research Ethics Committee (REC), 26/03/2010, ref: 09/H0308/187

Study design

Open-label parallel-group randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Patient information can be found at: http://www.phpc.cam.ac.uk/pcu/files/2008/04/GM-Participant-information-sheet-v6.0_17-04-2012_web.pdf

Condition

Physical activity, fitness & related metabolic diseases & cardiovascular risk factors

Intervention

Following a baseline measurement visit, participants will be randomised into one of four groups:
1. Comparison group – no intervention
2. Self-monitoring using a paper diary
3. Activity band with web-based feedback graphs
4. Activity band with web-based feedback graphs and support programme
The intervention will last for 12 weeks, after which time follow-up measurements are taken.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Physical activity energy expenditure (PAEE) kJ/kg/day
2. Fitness (predicted VO2max) ml O2/min/kg
All outcomes will be measured at baseline and post-intervention (12 weeks)

Secondary outcome measures

1. Anthropometric measures (BMI, body fat percentage, waist)
2. Blood pressure
3. Plasma vitamin C levels
4. Biochemical measures (HbA1c, cholesterol, triglycerides)
5. Self-reported quality of life, using SF-8
6. Theory of planned behaviour measures
7. Perceived stress, using 4-item Perceived Stress Scale
8. Self-monitoring behaviour
9. Self-reported physical activity (RPAQ)
All outcomes will be measured at baseline and post-intervention (12 weeks)

Overall trial start date

01/07/2010

Overall trial end date

31/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 - 65 at the start of the study
2. Has freely given informed consent
3. Has personal use of a Windows PC and the internet at home

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

480

Participant exclusion criteria

1. A score of ≥ 30 on the Godin Leisure-Time Exercise Questionnaire (using moderate and vigorous activities only)
2. Participation in another human or clinical randomised trial
3. Instructed by their GP not to engage in regular physical activity
4. Taking ≥ 100 mg a day of a beta-blocker such as Atenolol or equivalent
5. Women who are pregnant
6. Planning to leave employment at Addenbrooke’s Hospital in the 4 months following recruitment
7. Unable to walk briskly on the flat for 15 minutes without help
8. Unable to operate a PC unaided or cannot use an English-language website
9. Body mass index (BMI) of ≤18 kg/m2
10. Mean blood pressure of ≥ 160/100 mmHg

Recruitment start date

01/07/2010

Recruitment end date

31/12/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Public Health
Cambridge
CB2 0SR
United Kingdom

Sponsor information

Organisation

University of Cambridge (UK)

Sponsor details

c/o Carolyn Read
Research Governance Officer
University of Cambridge School of Clinical Medicine
Box 111 Cambridge Biomedical Campus
Cambridge
CB2 0SP
United Kingdom

Sponsor type

University/education

Website

http://www.medschl.cam.ac.uk/research/research-governance-information/

Funders

Funder type

Research council

Funder name

Medical Research Council

Alternative name(s)

MRC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Funder name

Imperative Health Ltd (UK) - General Practice & Primary Care Research Unit

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Added 27/06/2014:

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Institute for Health Research - Research for Patient Benefit (NIHR RfPB) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2015 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/25879726

Publication citations

Additional files

Editorial Notes

13/03/2017: Publication reference added. 27/06/2014: The following changes were made to the trial record: 1. National Institute for Health Research - Research for Patient Benefit (NIHR RfPB) (UK) was added as a funder. 2. The previous joint sponsor for this trial was: Medical Research Council (MRC) (UK) Epidemiology Unit Institute of Metabolic Science Box 285 Addenbrooke's Hospital Hills Road Cambridge CB2 0QQ United Kingdom The current address can be found in the sponsor section.