Condition category
Nutritional, Metabolic, Endocrine
Date applied
25/07/2014
Date assigned
15/09/2014
Last edited
15/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
We want to use SMS messages to improve engagement with a programme to prevent diabetes in Southwark. We propose to use SMS messages to give out periodic reminders, feedback on physical activity, motivational messages, and comparisons with others on the programme. The aim of these SMS messages is to increase motivation and improve people’s health. The messages will be delivered by the automated IT system called ‘Refer¬All’, which is already in place in Southwark (as well as other Local Authorities). There will be no difference in regular patient care. This study looks at the effect of SMS text messages.

Who can participate?
Participants are those patients engaged with the ‘Walking Away from Diabetes’ (WAFD) service in Southwark Borough in London who have regular access to a mobile phone.

What does the study involve?
Participants are randomly allocated to the intervention or the control group. Our intervention concentrates on the ‘Walking Away from Diabetes’ (WAFD) programme. This is a 12-week course that starts with a three-hour workshop that explains the benefits of physical activity and eating properly. Participants are all given a pedometer at the end of this workshop and told to record the number of steps they walk each day. They will be sent text messages about physical activity and reminders. After 12 weeks participants are called in to re-check their risk of diabetes. Information on number of steps walked will be gathered by a data link between participants’ pedometers and the IT system that issues the text messages. The control group receives usual care and does not receive any text messages.

What are the possible benefits and risks of participating?
The benefits of taking part are limited to the support provided by the SMS text messages during the 12-week programme. These include motivational, reminder and feedback information. These are designed to help participants stay motivated and engaged in sufficient physical activity and dietary changes to help reduce their risk of diabetes.

Where is the study run from?
Participants are recruited from 'Walking Away from Diabetes' session in Southwark, UK.

When is the study starting and how long is it expected to run for?
The study will start at the end of July 2014 and continue until the end of 2014.

Who is funding the study?
Public Health England, UK.

Who is the main contact?
Dr Tim Chadborn
tim.chadborn@phe.gov.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Tim Chadborn

ORCID ID

Contact details

Skipton House
80 London Road
London
SE1 6LH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Public Health England R&D Ref:R&D 185 REC Ref 14/SC/1027

Study information

Scientific title

Improving the outcomes of NHS Health Checks in Southwark: a randomised controlled trial

Acronym

Study hypothesis

That SMS text messages that provide feedback on activity, general motivation, and reminders of a re-test will reduce participants' risk of diabetes (measured by HbA1C score). A secondary hypothesis is that the group receiving the messages will have a higher average steps per day, and a higher usage rate.

Ethics approval

NRES Committee South Central- Berkshire B, 29/05/2014, ref. 14/SC/1027

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please email Hugo.harper@behaviouralinsights.co.uk to request a patient information sheet

Condition

Prediabetes risk

Intervention

This is a two arm trial: intervention and control:
1. The intervention group will receive SMS text messages that contain feedback on their performance relative to others in the programme, generic motivational messages, and reminders that they will have their risk re-assessed at the end of the 12 weeks. These messages will be received during the 12-week course. Participants will not receive more than six messages per week.
2. The control group will not receive these text messages - they will receive usual care.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Difference in HbA1c levels after the 12-week course

Secondary outcome measures

1. Average steps walked per day
2. Usage rates of pedometer, measured by number of days have a greater than 50 step rating.

Overall trial start date

26/07/2014

Overall trial end date

01/01/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Possible participants are patients who are recommended to attend a 'Walking Away from Diabetes' session in Southwark. This recommendation may occur for a number of reasons and is at the discretion of clinicians and the public health team at Southwark Local Council
2. All participants will have completed full consent to participate in the trial
3. Participants will be over 35 and of both genders

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant exclusion criteria

Participants who do not have regular access to a mobile telephone are excluded as they would not be able to receive the text messages.

Recruitment start date

26/07/2014

Recruitment end date

01/01/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Skipton House
London
SE1 6LH
United Kingdom

Sponsor information

Organisation

Public Health England (UK)

Sponsor details

c/o Elizabeth Coates
Porton Down
Salisbury
SP5 0JG
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Public Health England (UK)

Alternative name(s)

PHE

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

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