Study to evaluate a smartphone application for raising diabetes risk awareness in urban India

ISRCTN ISRCTN08439795
DOI https://doi.org/10.1186/ISRCTN08439795
Secondary identifying numbers SKN-APP-0328
Submission date
16/05/2012
Registration date
31/05/2012
Last edited
30/11/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Emma Bertenshaw
Scientific

Unilever Discover
Colworth Science Park
Sharnbrook
Bedford
MK44 1LQ
United Kingdom

Study information

Study designRandomised parallel multi-centred single-blind controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleExploratory pilot study to evaluate a diabetes risk awareness smartphone application with high risk individuals in urban India
Study objectivesD-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(s)Unilever Independent Ethics Committee, Bangalore, India, 02/04/2012, ref: ETH2012_ N02
Health condition(s) or problem(s) studiedPre-Diabetes
InterventionInterventional 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 typeOther
Primary outcome measure1. 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 measures1. Self-efficacy
2. Emotional response to the risk
3. Self-reported health information seeking and preventative behaviour
4. Qualitative appraisal of the app
Overall study start date16/05/2012
Completion date01/07/2012

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
SexBoth
Target number of participants200 participants
Key inclusion criteria1. 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)
Key exclusion criteria1. 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
Date of first enrolment16/05/2012
Date of final enrolment01/07/2012

Locations

Countries of recruitment

  • England
  • India
  • United Kingdom

Study participating centre

Unilever Discover
Bedford
MK44 1LQ
United Kingdom

Sponsor information

Unilever Discover (UK)
Industry

Colworth Science Park
Sharnbrook
Bedford
MK44 1LQ
United Kingdom

Website http://www.unilever.co.uk/
ROR logo "ROR" https://ror.org/05n8ah907

Funders

Funder type

Industry

Unilever Discover (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan