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

ISRCTN	ISRCTN08439795
DOI	https://doi.org/10.1186/ISRCTN08439795
Protocol serial number	SKN-APP-0328
Sponsor	Unilever Discover (UK)
Funder	Unilever Discover (UK)

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

Primary study design	Interventional
Study design	Randomised parallel multi-centred single-blind controlled study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Exploratory pilot study to evaluate a diabetes risk awareness smartphone application with high risk individuals in urban India
Study objectives	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(s)	Unilever Independent Ethics Committee, Bangalore, India, 02/04/2012, ref: ETH2012_ N02
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	1. Self-efficacy 2. Emotional response to the risk 3. Self-reported health information seeking and preventative behaviour 4. Qualitative appraisal of the app
Completion date	01/07/2012

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	All
Target sample size at registration	200
Key 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)
Key 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
Date of first enrolment	16/05/2012
Date of final enrolment	01/07/2012

Locations

Countries of recruitment

United Kingdom
England
India

Study participating centre

Unilever Discover

Bedford
MK44 1LQ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes