Condition category
Nutritional, Metabolic, Endocrine
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The aim of this study is to look for better ways to make web-pages to help people with diabetes. We have developed new web-pages and would like to test whether or not these are easier to use than standard information.

Who can participate?
Adults with type 2 diabetes can take part in this study.

What does the study involve?
This study will compare different types of web-pages for people with diabetes to see which is more helpful. To find this out, we need to put people into two groups and give each group different web-pages to look at. To try to make sure the groups are the same to start with, each person is put into a group by chance (randomly). If you decide to take part in this study, it will take about 30 minutes in total. The website will ask you to answer a questionnaire. You will then be shown the web-pages, and afterwards you will be asked to fill in another questionnaire.

What are the possible benefits and risks of participating?
Taking part in this study will help us identify better ways to make web-pages to help people with diabetes. The main risk is that you may not like the web-pages we have developed.

Where is the study run from?
This study is organised by researchers at the University of Southampton, but the study will be carried out over the internet.

When is the study starting and how long is it expected to run for?
We expect to recruit participants from July 2014 to July 2015.

Who is funding the study?
This study is part of a bigger project to improve the health of people with diabetes that is funded by the European Council.

Who is the main contact?
Dr Ingrid Muller

Trial website

Contact information



Primary contact

Dr Ingrid Muller


Contact details

University Road
SO17 1BJ
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Developing and testing accessible web-based support for patient self-management of diabetes


Study hypothesis

The aim of this work-package is to develop and trial web-based support suitable for people with lower levels of health literacy. In particular, it will examine the potential for web-based materials and tools to provide enhanced support (compared with standard written materials) by:

1. Tailoring the material to the particular needs, abilities and perspective of the user
2. Employing engaging audio-visual presentation and quiz formats
3. Providing simple interactive tools to support self-management tasks (e.g. guidance for choosing and planning lifestyle changes).

More details can be found at:

On 17/04/2014 the anticipated start date was changed from 31/05/2013 to 01/07/2014.

On 30/04/2014 the anticipated end date was changed from 31/01/2015 to 01/07/2015.

Ethics approval

NRES London – Hampstead Committee,18/03/2013, 13/LO/0316

Study design

Randomised; Interventional; Design type: Process of Care

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Quality of life

Patient information sheet




Current interventions as of 17/04/2014:
1. Interactive web-based materials: web-based-materials that are tailored, interactive and includes interactive tools
2. Static web-based materials: static version of the interactive web-based materials

Previous interventions:
1. Interactive web-based materials: web-based-materials that are tailored, interactive and includes interactive tools
2. Standard written materials: materials currently available
3. Static web-based materials: static version of the interactive web-based materials

Intervention type



Phase I/II

Drug names

Primary outcome measures

Current primary outcome measures as of 17/04/2014:
User engagement, measured by intervention completion rates

Previous primary outcome measures:
Patient enablement; Timepoint(s): immediately post intervention

Secondary outcome measures

Current secondary outcome measures as of 17/04/2014:
1. Physical activity attitudes and intentions
2. Patient enablement
3. Website satisfaction
4. Diabetes and physical activity knowledge
All of these will be measured immediately post intervention

Previous secondary outcome measures:
1. Comprehension and satisfaction with materials; Timepoint(s): immediately post intervention
2. Health literacy; Timepoint(s): immediately post intervention
3. Intention to take part in physical activity; Timepoint(s): immediately post intervention

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Adults (Male & Female; Upper Age Limit 120 years ; Lower Age Limit 18 years) with Type 2 diabetes
2. Who are able to consent

Participant type


Age group




Target number of participants

Planned Sample Size: 250; UK Sample Size: 250

Participant exclusion criteria

GPs will screen lists of potential participants to exclude individuals where there may be potential difficulties, for instance:
1. Severe mental health problems
2. Palliative care
3. Recent bereavement
4. Known opposition to involvement in research or inability to complete research measures, e.g. learning disability, inability to read / speak English.

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University Road
SO17 1BJ
United Kingdom

Sponsor information


University of Southampton (UK)

Sponsor details

Aldermoor Health Centre
SO17 1BJ
United Kingdom

Sponsor type




Funder type


Funder name

European Union Commission Framework 7 (Belgium)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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