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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ANZCTR
Last refreshed on: 13 January 2020
Main ID:  ACTRN12615000423516
Date of registration: 04/05/2015
Prospective Registration: No
Primary sponsor: Arogya World
Public title: mDiabetes – a Large Diabetes Prevention Text Messaging Initiative in India
Scientific title: In adult consumers in India, does receiving text messages, when compared to not receiving messages, improve health behaviors known to prevent diabetes?
Date of first enrolment: 25/10/2012
Target sample size: 1800
Recruitment status: Completed
URL:  https://anzctr.org.au/ACTRN12615000423516.aspx
Study type:  Interventional
Study design:  Purpose: Prevention; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;  
Phase:  Not Applicable
Countries of recruitment
India
Contacts
Name: Dr Sandhya Ramalingam   
Address:  34B, Dream Meadows Layout, ITPL Road Bangalore - 560 0066 India
Telephone: +91 988 606 1600
Email: sandhya@arogyaworld.org
Affiliation: 
Name: Dr Nalini Saligram   
Address:  Arogya World 23W651 Hobson Road Naperville IL 60540 United States of America
Telephone: +1 630 637 8923
Email: nalini@arogyaworld.org
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: Experimental – Having Nokia mobile phone (series 30 or 40) with Nokia Life Platform and opting-in for Diabetes channel

Controls – Adult consumers with non-Nokia mobile phones

Exclusion criteria: Consumers below age 18 years were excluded. Non-subscribers of Nokia Life Health channel were also excluded.

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females
Health Condition(s) or Problem(s) studied
Metabolic and Endocrine - Diabetes
Diabetes Prevention;
Diabetes Prevention
Public Health - Health promotion/education
Intervention(s)
Over 62 million individuals have been diagnosed with diabetes in India, creating a significant public health problem. India, a country with approximately 900 million mobile phone subscribers, is an optimal location to test effects of large-scale mHealth interventions to address burdensome chronic diseases. Arogya World’s mDiabetes program, a diabetes prevention text-messaging program among one million consumers from all over India, looked at the effectiveness of text messages in encouraging health behaviors known to prevent diabetes.

The current study employs a non-randomized, prospective, parallel cohort design to test the impact of text messages on health behavior change. The study had two arms – Experimentals and Controls. Experimentals were about 900 Nokia mobile phone users who opted in to receive 56 diabetes prevention text messages in their choice of 12 languages, while Controls (N=900) received no text messages or contact during the 6 month intervention period.

The frequency of text messages was as follows - one a day for the first 6 days, then twice a week for the rest of the weeks, up to 6 months. The content of the messages was different - some described how big a problem diabetes was in India, others that there were medical studies that showed that diabetes was preventable with lifestyle changes, that healthy living included increasing physical activity and improving diets. And the messages went on to cover how to incorporate physical activity into everyday lives, and also encouraged consumers to eat more fruits and vegetables and limit oily and sugary foods.

All participants were surveyed by phone at baseline and 6 months to assess a selection of health behaviors.

The study showed encouraging results - 35% of the expe
Primary Outcome(s)
Increase in adoption of healthy lifestyles, known to prevent diabetes, as measured by comparing self reported behavior change in Experimentals and Control parallel cohorts of adult consumers in India

[Health behaviour in both Experimentals and Controls was assessed before intervention began and at six months, when intervention was completed, by asking 600 plus responders from each group, a set of questions. For eg - What foods they ate. How many fruits and vegetables they ate a day. Whether they exercised regularly. And whether they consistently avoided eating fried foods etc. ]
Secondary Outcome(s)
Among non-responders, do text messages improve intent to change behavior?[Health behaviour in both Experimentals and Controls was assessed as mentioned above, before intervention began and at six months, when intervention was completed, by asking 600 plus responders from each group, a set of questions and then further questioning the non-responders about when they intended to make the change.

For eg - For those who answered No to the question - Do you exercise currently, we asked the question -Are you considering beginning to exercise or starting any physical activity? And gave them choices of
i. yes, in 30 days,
ii. yes in six months
iiii. not very soon.

Those who answered yes, in 30 days, were then included in further analysis for intent to change behavior.
]
Are there any differences in responses to text messages among rural versus urban consumers, and North Indian versus South Indian consumers?[Health behaviour in both Experimentals and Controls was assessed as mentioned above, before intervention began and at six months, when intervention was completed, by asking 600 plus responders from each group, a set of questions about the foods they ate and the physical activity they engaged in.

The data were then subsequently further analyzed by location ie based on whether the responder came from a rural location or an urban location, or North or South India.
]
Secondary ID(s)
none
Source(s) of Monetary Support
Arogya World
Secondary Sponsor(s)
Johnson & Johnson (Lifescan Inc.)
Aetna
Ethics review
Status: Approved
Approval date:
Contact:
Centre for Chronic Disease Control Institutional Ethics Committee
Results
Results available:
Date Posted:
Date Completed:
URL:
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