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22 May 2012
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| [ Print-friendly version ] |
| Movement as medicine for type 2 diabetes |
| ISRCTN | ISRCTN67997502 |
| ClinicalTrials.gov identifier | |
| Public title | Movement as medicine for type 2 diabetes |
| Scientific title | Feasibility, acceptability and effectiveness of a multi-faceted behavioural intervention targeting levels of physical activity in adults with type 2 diabetes in primary care: movement as medicine for type 2 diabetes |
| Acronym | N/A |
| Serial number at source | N/A |
| Study hypothesis | A theory-based behavioural intervention will be more effective than standard clinical care for impacting positively on levels of free living physical activity and concomittant levels of glycated hemoglobin) (HbA1c) |
| Lay summary |
Lay summary added as of 24/04/2012
Background and study aims Research has shown that increasing levels of physical activity can produce significant improvements in blood glucose control in people with Type 2 diabetes. What is not well understood is how best to support people with Type 2 diabetes to become more physically active and maintain this over time. This study aims to find out whether the use of structured support provided by healthcare professionals in primary care is feasible, acceptable and effective for increasing levels of physical activity and improving glucose control in people with Type 2 diabetes. Who can participate? Adults aged 18 years or over Have a confirmed diagnosis of non-insulin dependent Type 2 diabetes (diabetes controlled by diet, oral medication or both – not insulin) Diagnosis of non-insulin dependent diabetes for a minimum of two years Have physical activity levels below the current recommendations of 30 minutes or more on at least five days of the week What does the study involve? All primary care practices in the County Durham and Darlington region will be invited to take part in the study. 40 practices will be selected to take part and allocated at random to one of two groups, structured support or usual clinical care. Healthcare professionals from practices allocated to the structured support group will be specifically trained to provide evidence-based support to their patients to help them to become more physically active and maintain this over time. They will do this with the help of a specially developed Movement as Medicine ‘toolkit’. Every patient who joins the study in practices allocated to structured support will receive their own toolkit. All the patients in the structured support group will have to attend four diabetes review appointments over a 12 month period, complete a questionnaire at the start of the study, and again one, three, six and 12 months later. Patients will have to wear a physical activity monitor for seven days at the start of the study, and again one, three, six and 12 months later Practices allocated to the usual clinical care group will be asked to deliver care as they usually would during diabetes review appointments. What are the possible benefits and risks of participating? Structured support provided by healthcare professionals in primary care will possibly help people with Type 2 diabetes in increasing levels of physical activity and improving glucose control. No risks associated with participating in the study. Where is the study run from? The study is run by Newcastle University; however it will be carried out in primary care practices across the County Durham and Darlington region. When is study starting and how long is it expected to run for? The study is expected to start during July 2012 and will run for 24 months. The last patient will be recruited 12 months after the study starts. Who is funding the study? The study is funded by NHS Health Innovation and Education Cluster (HIEC) and the Medical Research Council (MRC). Who is the main contact? Dr Mike Trenell michael.trenell@ncl.ac.uk |
| Ethics approval | Not provided at time of registration |
| Study design | Single centre clustered randomised controlled with parallel groups |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Non-insulin dependent type 2 diabetes |
| Participants - inclusion criteria |
1. Adults aged ≥18 years
2. Diagnosis of non-insulin dependent type 2 diabetes for a minimum of two years 3. Physical activity/ exercise is below recommendations (i.e. 30 minutes per day three times per week) 4. Capacity to provide informed consent 5. Ability to write and converse in English |
| Participants - exclusion criteria | Contra-indications to performing physical activity |
| Anticipated start date | 01/07/2012 |
| Anticipated end date | 31/03/2014 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | A total of 400 adults with type 2 diabetes will be randomly selected. An equal number (200 per group) will be entered in to the intervention and control arm of the trial |
| Interventions |
A theory based accredited online training programme for primary care practitioners and a toolkit of paper-based materials, activity planners and trackers, a pedometer and DVD.
Intervention group: Patients will attend four face to face diabetes review appointments over a 12 month period (baseline, 1, 6 and 12 months) where they will be supported using the toolkit to increase their levels of physical activity. In addition both the intervention and control group will receive a telephone call at 3 months. Control group: Standard clinical care |
| Primary outcome measure(s) |
Primary care practitioners:
Counselling and behaviour change skills Patients: Objectively and subjectively assessed physical activity behaviour |
| Secondary outcome measure(s) |
Primary care practitioners:
1. Diabetes and physical activity-related knowledge and attitudes/beliefs 2. Self efficacy for delivering physical activity-related counseling to adults with type 2 diabetes Patients: 1. Glucose control (HbA1c) 2. Blood pressure 3. Body mass index (BMI) and waist circumference 4. Diabetes and physical activity related knowledge and attitudes/beliefs 5. Physical activity related self efficacy 6. Health-related quality of life |
| Sources of funding | NHS North East Health Innovation Education Cluster (UK) |
| Trial website | |
| Publications | |
| Contact name | Dr Michael Trenell |
| Address |
Newcastle University
Faculty of Medical Sciences Institute of Cellular Medicine William Leech Building |
| City/town | Newcastle upon Tyne |
| Zip/Postcode | NE2 4HH |
| Country | United Kingdom |
| Tel | +44 (0)191 222 6935 |
| Fax | +44 (0)191 222 5685 |
| michael.trenell@ncl.ac.uk | |
| Sponsor | NHS County Durham and Darlington (UK) |
| Address |
c/o Mr Richard Errington
John Snow House Durham University Science Park |
| City/town | County Durham |
| Zip/Postcode | DH1 3YG |
| Country | United Kingdom |
| Tel | +44 (0)191 374 4211 |
| richard.errington@nhs.net | |
| Sponsor website: | http://www.countydurham.nhs.uk/ |
| Date applied | 11/01/2012 |
| Last edited | 24/04/2012 |
| Date ISRCTN assigned | 23/01/2012 |
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