Condition category
Nutritional, Metabolic, Endocrine
Date applied
16/05/2012
Date assigned
31/05/2012
Last edited
30/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Emma Bertenshaw

ORCID ID

Contact details

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

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 measures

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

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

http://www.unilever.co.uk/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes