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 Addenbrookes 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 peoples 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 Addenbrookes 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
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 measure
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 (if study stopped)
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 Addenbrookes 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
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
31/12/2019
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2015 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/25879726
Publication citations
Additional files
- ISRCTN31844443 _SAP_20Feb14.pdf Uploaded 25/02/2019