Condition category
Not Applicable
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
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?
You will have a comprehensive health and fitness check where we will measure your height, weight and blood pressure and take a blood sample (less than 2 tablespoons) to measure your cholesterol, glucose levels and nutritional status. Other measurements like body composition and an ECG (heart trace) reading will also be taken and we will ask you to fill in two questionnaires, which should take around 20 minutes to complete. In order to measure fitness and physical activity levels we will ask you to 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 for you. You only need remain on the treadmill for as long as you feel comfortable. We will also ask you to wear a small heart rate monitor on your chest for 6 days after your visit. When you have worn the heart rate monitor for 6 days, we will ask you to return it to us. Once we have checked sufficient activity data have been recorded, we will get in touch about how the study will progress for you.
You will then be randomly allocated into one of four study groups: three groups will involve participants monitoring their physical activity daily using different methods, and one group will 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
The activity band is worn like a watch. Information on the wearer’s physical activity levels is uploaded via Bluetooth to the program website where you can also access the support and/or feedback programs. Participants in group 4 will also receive a set of interactive Bluetooth-enabled weighing scales to enable them to monitor their weight. After 12 weeks all participants will 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 will be the same as your first visit. This will allow us to see if anything has changed over the 12-week period. You will be asked to wear the heart rate monitor again for 6 days prior to the visit. After the visit, we will ask you to complete a final questionnaire and return this by post.
You may also be invited to take part in a short, audio-recorded interview with a researcher who will ask you about your own ideas about behaviour related to physical activity, what you thought of the intervention you received, and your experience of taking part in the study. This will help us understand the extent to which behaviour changes might become long-term habits.

What are the possible benefits and risks of participating
We will provide you with a comprehensive health report detailing the clinical results from both your assessments. With your permission we will provide your GP with the results of your health and fitness assessments. This will allow you to discuss your results with your GP, should you 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 you to adopt a more physically active lifestyle while you are in the study, these benefits rely on you maintaining this lifestyle once the study finishes.
The risks to you in taking part in the study are negligible. You 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 your practice nurse or GP. Trained staff take blood samples and carry out all measurements. Thorough medical checks will be undertaken before volunteers 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. You will be provided with information at your visit as to what to do if this happens whilst you are wearing the monitor. If you increase the amount of physical activity you do, you increase the risk that you will experience 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?
The study ran from July 2010 to December 2013.

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

Who is the main contact?
Prof Simon Griffin

Trial website

Contact information



Primary contact

Prof Simon Griffin


Contact details

Institute of Public Health
University Forvie Site
Robinson Way
United Kingdom
+44 (0) 1223 763431

Additional identifiers

EudraCT number number

Protocol/serial number


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


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


Secondary study design

Randomised controlled trial

Trial setting


Trial type

Quality of life

Patient information sheet

Patient information can be found at:


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


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.

The previous joint sponsor for this trial (up to 27/06/2014) was:
Medical Research Council (MRC) (UK)
Epidemiology Unit
Institute of Metabolic Science Box 285
Addenbrooke's Hospital
Hills Road
United Kingdom
The current address can be found in the sponsor section below.

Intervention type



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


Overall trial end date


Reason abandoned


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


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Institute of Public Health
United Kingdom

Sponsor information


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
United Kingdom

Sponsor type




Funder type

Research council

Funder name

Medical Research Council (MRC) (UK) - Epidemiology Unit

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Added 27/06/2014:

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Publication citations

Additional files

Editorial Notes