Plain English Summary
Background and study aims
Diabetes is a lifelong condition that causes a person's blood sugar level to become too high. A large number of people in India do not realize they are at risk of developing diabetes or that they have the condition. A prototype smartphone application called D-Check has been designed to communicate personal diabetes risk and contains persuasive messages to
motivate high-risk individuals to take action. The aim of this study is to assess whether D-Check has a beneficial educational and/or motivational effect for example on intentions to get a diabetes blood screening test.
Who can participate?
Healthy volunteers, aged 30-60, living in Mumbai or Chennai, who are at high risk of diabetes.
What does the study involve?
Participants complete questionnaires to assess diabetes general knowledge, beliefs, perceptions and motivation to take diabetes preventative action (i.e. go for a diabetes screening test, eat a healthy diet most of the time, take regular exercise). Two weeks later, all participants use a smartphone application at a test centre. Particpants are randomly allocated into two groups. Half the participants use the D-Check application and the other half use a commercially available financial app. After using the apps, all participants again answer questions about their diabetes beliefs, perceptions and motivation to take preventative action. Two weeks later, participants receive a follow-up visit to assess diabetes general knowledge.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
Unilever Discover (UK).
When is the study starting and how long is it expected to run for?
May to July 2012.
Who is funding the study?
Unilever Discover (UK).
Who is the main contact?
1. Emma Bertenshaw
2. Dr.A.Ramachandran
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SKN-APP-0328
Study information
Scientific title
Exploratory pilot study to evaluate a diabetes risk awareness smartphone application with high risk individuals in urban India
Acronym
Study hypothesis
D-Check - a prototype diabetes risk smartphone application (app) - will change diabetes perceptions and motivation to engage in preventative behaviour amongst high risk individuals, compared to a control condition.
Ethics approval
Unilever Independent Ethics Committee, Bangalore, India, 02/04/2012, ref: ETH2012_ N02
Study design
Randomised parallel multi-centred single-blind controlled study
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 use the contact details below to request a patient information sheet
Condition
Pre-Diabetes
Intervention
Interventional group: provision of a D-Check diabetes smartphone application in a controlled environment.
Control group: provision of a commercially available financial application in a controlled environment.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Change in intention to engage in preventative action (i.e. blood screening, taking regular exercise and eating a healthy diet) from baseline to post intervention (two weeks later)
2. Change in diabetes risk perceptions and beliefs including susceptibility, perceived severity and perceived outcomes of taking diabetes preventative action, from baseline to post intervention
3. Change in Diabetes awareness & knowledge from baseline to follow-up (four weeks later)
Secondary outcome measures
1. Self-efficacy
2. Emotional response to the risk
3. Self-reported health information seeking and preventative behaviour
4. Qualitative appraisal of the app
Overall trial start date
16/05/2012
Overall trial end date
01/07/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Healthy volunteers
2. Female and male, between 30-60 years old
3. Living in Mumbai or Chennai
4. Regularly read in English
5. Have good vision
6. Use smartphone applications on a regular basis
7. At high risk of diabetes (defined by a risk score over 21)
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
200 participants
Participant exclusion criteria
1. Diabetics
2. Had blood screened for diabetes - or any other tests of diabetes status - within the last year
3. Disability that impacts physical activity status or use of a mobile phone
Recruitment start date
16/05/2012
Recruitment end date
01/07/2012
Locations
Countries of recruitment
India
Trial participating centre
Unilever Discover
Bedford
MK44 1LQ
United Kingdom
Sponsor information
Organisation
Unilever Discover (UK)
Sponsor details
Colworth Science Park
Sharnbrook
Bedford
MK44 1LQ
United Kingdom
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Unilever Discover (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
Basic results (scientific)
Publication list