Movement as medicine for type 2 diabetes
| ISRCTN | ISRCTN67997502 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67997502 |
| Protocol serial number | N/A |
| Sponsor | NHS County Durham and Darlington (UK) |
| Funder | NHS North East Health Innovation Education Cluster (UK) |
- Submission date
- 11/01/2012
- Registration date
- 23/01/2012
- Last edited
- 25/02/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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 with Type 2 diabetes (diabetes controlled by diet, oral medication or both, not insulin)
What does the study involve?
All primary care practices in the County Durham and Darlington region are invited to take part in the study. 40 practices are selected to take part and randomly allocated to one of two groups: structured support or usual clinical care. Healthcare professionals from practices allocated to the structured support group are specifically trained to provide evidence-based support to their patients to help them to become more physically active and maintain this over time. They 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 receives their own toolkit. All the patients in the structured support group 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 have to wear a physical activity monitor for 7 days at the start of the study, and again one, three, six and 12 months later. Practices allocated to the usual clinical care group are 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 may help people with Type 2 diabetes in increasing levels of physical activity and improving glucose control. There are 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 the study starting and how long is it expected to run for?
July 2012 to December 2014
Who is funding the study?
1. NHS Health Innovation and Education Cluster (HIEC) (UK)
2. Medical Research Council (MRC) (UK)
Who is the main contact?
Prof. Mike Trenell
michael.trenell@ncl.ac.uk
Contact information
Scientific
Newcastle University
Faculty of Medical Sciences
Institute of Cellular Medicine
William Leech Building
Newcastle upon Tyne
NE2 4HH
United Kingdom
| Phone | +44 (0)191 222 6935 |
|---|---|
| michael.trenell@ncl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre clustered randomised controlled with parallel groups |
| Secondary study design | Cluster randomised trial |
| Study type | Participant information sheet |
| 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 |
| Study objectives | 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). |
| Ethics approval(s) | Sunderland REC committee, 13/04/2012, ref: 12/NE/0037 |
| Health condition(s) or problem(s) studied | Non-insulin-dependent type 2 diabetes |
| Intervention | 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 |
| Intervention type | Other |
| Primary outcome measure(s) |
Primary care practitioners: |
| Key secondary outcome measure(s) |
Primary care practitioners: |
| Completion date | 01/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 200 |
| Key inclusion criteria | Current inclusion criteria as of 15/07/2013: 1. Adults aged ≥18 years 2. Diagnosis of non-insulin dependent type 2 diabetes for a minimum of two years 3. Capacity to provide informed consent 4. Ability to write and converse in English Previous 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 |
| Key exclusion criteria | Contra-indications to performing physical activity |
| Date of first enrolment | 01/07/2012 |
| Date of final enrolment | 01/12/2014 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
NE2 4HH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 03/02/2014 | Yes | No | |
| Abstract results | results presented at Diabetes UK Professional Conference at | 01/03/2015 | No | No | |
| Other publications | intervention development | 19/07/2016 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
25/02/2021: Publication reference added.
12/01/2017: Publication reference added.
15/07/2013: The following changes were made to the trial record:
1. The target number of participants was changed from 400 to 200.
2. The overall trial end date was changed from 31/03/2014 to 01/12/2014.
