Condition category
Nutritional, Metabolic, Endocrine
Date applied
10/07/2014
Date assigned
20/08/2014
Last edited
16/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
People with type 2 diabetes have to take very good care of their health . Among other things, physical activity is very important as it helps to reduce and maintain glucose level in the blood. It is vital that people with type 2 diabetes do regular exercise (physical activity) in order to maintain a healthy blood glucose levels . Here, we investigate how good avirtual health trainer, which is accessible through a website, is at promoting physical activity in people with type 2 diabetes living in remote and/or rural areas of the UK.

Who can participate?
Adults with diabetes, managing their disease with pills or lifestyle changes and residents of Inverness, Fort William, Skye and Caithness areas of the UK, can take part.

What does the study involve?
Participants will be randomly allocated to receive the interactive virtual health trainer (intervention group 1), information only virtual health trainer (intervention group 2) or usual care (standard care exercise information). Chemical changes within their body and their level of physical activity will be measured on three occasions over a 7 day period at the start of the study, then after three and six months. This will be compared with their self-reporting of physical activity and with the previous measures taken at the start of the study or 3 months. The usual care group will receive leaflets based on the website material regarding information on the benefits of physical activity on type 2 diabetes, current recommendations for physical activity and information on exercise and diabetes-related complications. The virtual health trainer group will also be given this information but is accessed through the website. The interactive virtual health group will have access to this information but will be able to log onto the website. This will give them access to interactive features such as a tool to monitor their physical activity, a physical activity consultation which will help them to set up goals and targets and the option to choose challenges which they can accomplish over a few physical activity sessions. This group will also have access to a map that can help them find places in their area to become more active. The website will act as a support tool to promote physical activity in remote areas. Each participant will be given a physical activity monitor(accelerometer) and asked to wear this for seven days during all waking hours to measure their level of activity at these time points. A small number of people of the group who already perform home blood glucose testing will also be asked to wear a continuous glucose monitoring system for three days at the same time they wear the accelerometer.

What are the possible benefits and risks of participating?
Participants will receive access to a support tool which helps increase and monitor physical activity. By increasing physical activity they may find improvements in their blood glucose and insulin sensitivity as well as other associated health benefits. We do not expect any significant risks as a result of taking part in this study. However patients may experience a little discomfort during the blood collection procedure and they will be warned that they may feel a little pain when the needle is inserted. Also increasing physical activity can result in some muscle soreness but structured advice will be given on how to best avoid this.

Where is the study run from?
The study is run from Inverness, Fort William, Skye and Caithness areas in the UK.

When is the study starting and how long is it expected to run for?
The study started in November 2013 and will run until September 2014.

Who is funding the study?
Lifescan Ltd, Inverness (UK)

Who is the main contact?
Miss Jenni Connelly
diabetesexercise@uhi.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Miss Jenni Connelly

ORCID ID

Contact details

Department of Diabetes and Cardiovascular Science
Centre for Health Science
Old Perth Road
Inverness
IV2 3JH
United Kingdom
diabetesexercise@uhi.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Trial of a virtual health trainer to promote physical activity in the management of type 2 diabetes in rural and remote areas

Acronym

Study hypothesis

To identify whether a web-based virtual trainer can increase physical activity in people with type 2 diabetes

Ethics approval

North of Scotland NRES Committee, 03/07/2014, ref.13/NS/0069

Study design

Single-centre interventional study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

Type 2 diabetes

Intervention

This is an intervention study where diabetes physical activity advice will be given to three different groups. The control group will receive written advice in leaflet form, intervention group 1 will receive the same advice but in the form of a website and the third group will have access to this advice as well as interactive components on the site.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Changes in physical activity
Measured over a 7 day period at baseline, and then three and six months using actigraph acclerometers

Secondary outcome measures

The following measures will be collected at three time points baseline, 3 months and 6 months.
1. Physiological Measures:
1.1. Blood pressure
1.2. Measurement of height
1.3. Weight and calculation of BMI
1.4. Waist/hip meaurements
2. Venepuncture - sampling blood to measure:
2.1. HbA1c
2.2. Cholesterol
3. Physical Activity: objectively measured using actigraph accelerometers and subjectively measured using the International Physical Activity Questionnaire (IPAQ).
4. Continuous blood glucose will be measured in a subsample of the group at the same three timepoints but for 6 days, these are measured using Medtronic iPro2.

Overall trial start date

04/11/2013

Overall trial end date

14/09/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. People with type 2 diabetes
2. Over 18 years old
3. Must manage their diabetes through lifestyle or oral medication
4. Able to give informed consent
5. Must be able to speak English
6. Resident in Inverness, Fort William, Skye and Caithness areas
7. Must have access to a computer with internet access

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

36

Participant exclusion criteria

1. Under 18 years old
2. Unable to give informed consent
3. Living outside the sample geographical areas
4. Must not manage their diabetes through insulin
5. Those with any physical disability or diabetes related complication that precludes increasing physical activity or impairs communication
6. People with visual or hearing impairments
7. People that have no access to the internet

Recruitment start date

04/11/2013

Recruitment end date

14/09/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Diabetes and Cardiovascular Science
Inverness
IV2 3JH
United Kingdom

Sponsor information

Organisation

University of The Highlands and Islands (UK)

Sponsor details

c/o Jenni Connelly
Department of Diabetes and Cardiovascular Science
Centre for Health Science
Old Perth Road
Inverness
IV2 3JH
United Kingdom

Sponsor type

Research organisation

Website

Funders

Funder type

Industry

Funder name

Lifescan Ltd, Inverness (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

Publication citations

Additional files

Editorial Notes