Improving the outcomes of NHS Health Checks in Southwark
| ISRCTN | ISRCTN51870347 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51870347 |
| Secondary identifying numbers | Public Health England R&D Ref:R&D 185 REC Ref 14/SC/1027 |
- Submission date
- 25/07/2014
- Registration date
- 15/09/2014
- Last edited
- 29/05/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
The aim of this study is to find out whether text messages improve engagement with a programme to prevent diabetes in Southwark. Text messages are used to give out periodic reminders, feedback on physical activity, motivational messages, and comparisons with others on the programme. The aim of these messages is to increase motivation and improve people's health. The messages are delivered by the automated IT system called Refer-All, which is already in place in Southwark (as well as other Local Authorities). There are no other differences in patient care.
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 are 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 are 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?
July 2014 to January 2015
Who is funding the study?
Public Health England (UK)
Who is the main contact?
Dr Tim Chadborn
Contact information
Scientific
Skipton House
80 London Road
London
SE1 6LH
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please email Hugo.harper@behaviouralinsights.co.uk to request a patient information sheet |
| Scientific title | Improving the outcomes of NHS Health Checks in Southwark: a randomised controlled trial |
| Study objectives | 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(s) | NRES Committee South Central- Berkshire B, 29/05/2014, ref. 14/SC/1027 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 26/07/2014 |
| Completion date | 01/01/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 300 |
| Key inclusion criteria | 1. 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. Completed full consent to participate in the trial 3. Over 35 and of both genders |
| Key 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. |
| Date of first enrolment | 26/07/2014 |
| Date of final enrolment | 01/01/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
SE1 6LH
United Kingdom
Sponsor information
Government
c/o Elizabeth Coates
Porton Down
Salisbury
SP5 0JG
United Kingdom
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- PHE
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
29/05/2020: No publications found.
09/05/2017: No publications found, verifying study status with principal investigator.
