Condition category
Nutritional, Metabolic, Endocrine
Date applied
11/01/2012
Date assigned
23/01/2012
Last edited
05/02/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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?
1. Adults aged 18 years or over
2. Have a confirmed diagnosis of non-insulin-dependent Type 2 diabetes (diabetes controlled by diet, oral medication or both – not insulin)
3. Diagnosis of non-insulin-dependent diabetes for a minimum of two years

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 the 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?
Professor Mike Trenell
michael.trenell@ncl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Michael Trenell

ORCID ID

Contact details

Newcastle University
Faculty of Medical Sciences
Institute of Cellular Medicine
William Leech Building
Newcastle upon Tyne
NE2 4HH
United Kingdom
+44 (0)191 222 6935
michael.trenell@ncl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

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).

Please note that as of 15/07/2013 this trial record was amended. Most of the changes to this record can be found in the relevant field, under the date on which the amendment was made. The following changes have also taken place:
1. Number of participants to be recruited was changed from 400 to 200
2. Anticipated end date of the study was changed from 31/03/2014 to 01/12/2014

Ethics approval

Added as of 15/07/2013: approved by Sunderland REC committee on 13/04/2012 (ref: 12/NE/0037)

Study design

Single-centre clustered randomised controlled with parallel groups

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

Primary care practitioners:
Counselling and behaviour change skills

Patients:
Objectively and subjectively assessed physical activity behaviour

Secondary outcome measures

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

Overall trial start date

01/07/2012

Overall trial end date

01/12/2014

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

A total of 200 adults with type 2 diabetes will be randomly selected. An equal number (100 per group) will be entered in to the intervention and control arm of the trial

Participant exclusion criteria

Contra-indications to performing physical activity

Recruitment start date

01/07/2012

Recruitment end date

01/12/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Newcastle University
Newcastle upon Tyne
NE2 4HH
United Kingdom

Sponsor information

Organisation

NHS County Durham and Darlington (UK)

Sponsor details

c/o Mr Richard Errington
John Snow House
Durham University Science Park
County Durham
DH1 3YG
United Kingdom
+44 (0)191 374 4211
richard.errington@nhs.net

Sponsor type

Hospital/treatment centre

Website

http://www.countydurham.nhs.uk/

Funders

Funder type

Hospital/treatment centre

Funder name

NHS North East Health Innovation Education Cluster (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

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24491134

Publication citations

  1. Protocol

    Avery L, Sniehotta FF, Denton SJ, Steen N, McColl E, Taylor R, Trenell MI, Movement as Medicine for Type 2 Diabetes: protocol for an open pilot study and external pilot clustered randomised controlled trial to assess acceptability, feasibility and fidelity of a multifaceted behavioural intervention targeting physical activity in primary care., Trials, 2014, 15, 46, doi: 10.1186/1745-6215-15-46.

Additional files

Editorial Notes