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Trial registered on ANZCTR


Registration number
ACTRN12615000423516
Ethics application status
Approved
Date submitted
11/02/2015
Date registered
4/05/2015
Date last updated
4/05/2015
Type of registration
Retrospectively registered

Titles & IDs
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?
Secondary ID [1] 286154 0
none
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Prevention 294160 0
Condition category
Condition code
Metabolic and Endocrine 294488 294488 0 0
Diabetes
Public Health 295095 295095 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 experimental group compared to 21% in the control group reported positively changing more than one health behavior (p<.001).

This study shows that large-scale text message based diabetes prevention interventions have the potential to be an effective option for population level health behavior change.
Intervention code [1] 291155 0
Prevention
Intervention code [2] 291156 0
Lifestyle
Intervention code [3] 291157 0
Behaviour
Comparator / control treatment
Consumers from all over India who had non-Nokia mobile phones and did not get our text messages
Control group
Active

Outcomes
Primary outcome [1] 294266 0
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

Timepoint [1] 294266 0
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 [1] 312907 0
Among non-responders, do text messages improve intent to change behavior?
Timepoint [1] 312907 0
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.
Secondary outcome [2] 312908 0
Are there any differences in responses to text messages among rural versus urban consumers, and North Indian versus South Indian consumers?
Timepoint [2] 312908 0
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.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Consumers below age 18 years were excluded. Non-subscribers of Nokia Life Health channel were also excluded.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The current study was designed to detect a 10% difference between groups with 80% power and 90% confidence . In absence of reliable estimates on the indicators of interest, a p value of 50% was assumed which produced a sample size estimate of 384 for each group. Assuming about a 15% rate of being lost to follow up and to distinguish differences between a rural and urban sample, the objective was to recruit at least 450 participants for each group. We doubled the number to be able to study rural and urban consumer responses.

All participant survey results collected at baseline were included in the analyses. Post-intervention surveys were matched to baseline surveys on phone number and demographic data. All surveys were included in the baseline analyses, but only matched surveys were included in the longitudinal analysis.

Chi-square tests were performed to detect group differences in baseline measures and retention as well as group differences in the ability to reach a level of behavior change during the intervention.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6650 0
India
State/province [1] 6650 0

Funding & Sponsors
Funding source category [1] 290724 0
Charities/Societies/Foundations
Name [1] 290724 0
Arogya World
Address [1] 290724 0
23W651 Hobson Road
Naperville IL 60540
Country [1] 290724 0
United States of America
Primary sponsor type
Charities/Societies/Foundations
Name
Arogya World
Address
23W651 Hobson Rd, Naperville IL 60540
Country
United States of America
Secondary sponsor category [1] 289414 0
Commercial sector/Industry
Name [1] 289414 0
Johnson & Johnson (Lifescan Inc.)
Address [1] 289414 0
One Johnson & Johnson Plaza
New Brunswick, New Jersey 08933
Country [1] 289414 0
United States of America
Secondary sponsor category [2] 289415 0
Commercial sector/Industry
Name [2] 289415 0
Aetna
Address [2] 289415 0
Aetna International | 151 Farmington Ave, Hartford, CT 06156
Country [2] 289415 0
United States of America
Other collaborator category [1] 278340 0
Commercial sector/Industry
Name [1] 278340 0
Nokia
Address [1] 278340 0
# 2A, 5th Floor, Jupiter Block, Prestige Technology Park, Kadabeesanahalli, Marathalli-Sarjapur Outer Ring Road,
Bangalore - 560103

Nokia India used to be at this address when we did our study. The mobile phone business was subsequently sold to one company and the Nokia Life business to yet another.
Country [1] 278340 0
India
Other collaborator category [2] 278341 0
University
Name [2] 278341 0
Emory University
Address [2] 278341 0
Emory University

1518 Clifton Rd NE

Atlanta, Georgia 30322
Country [2] 278341 0
United States of America
Other collaborator category [3] 278342 0
Charities/Societies/Foundations
Name [3] 278342 0
Public Health Foundation of India
Address [3] 278342 0
ISID Campus
4 Institutional Area
Vasant Kunj
New Delhi – 110070
Country [3] 278342 0
India
Other collaborator category [4] 278343 0
Charities/Societies/Foundations
Name [4] 278343 0
Madras Diabetes Research Foundation
Address [4] 278343 0
No 4, Conran Smith Road,
Gopalapuram,
Chennai - 600 086
Country [4] 278343 0
India

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292361 0
Centre for Chronic Disease Control Institutional Ethics Committee
Ethics committee address [1] 292361 0
Tower #4, C-9 Commercial Complex,
Vasant Kunj, New Delhi 110070
Ethics committee country [1] 292361 0
India
Date submitted for ethics approval [1] 292361 0
Approval date [1] 292361 0
17/10/2012
Ethics approval number [1] 292361 0
CCDC_IEC_12_2012

Summary
Brief summary
In India, there are more than 900 million mobile subscribers.

‘m-health’, defined as integration of mobile telecommunication technology in the health arena, has been successfully used as a behavior change communication medium in India : health related information delivered in the form of text messages via short message service (SMS), or as pictures through mobile phones, has effectively altered the knowledge, attitudes and behaviors of participants in fields such as for breast self-examination, oral health or HIV/AIDS.

This mobile phone based text messaging intervention is designed to address the benefits of changing lifestyle to prevent diabetes and to impact processes of change with greatest attention for people in the 'contemplation' to 'action' stages. This trial aims to test the efficacy of an SMS campaign to bring about behavior change known to prevent diabetes. The text messages are to be delivered in 12 languages over 6 months to about 900 participants (urban and rural) who have Nokia mobile phones and have subscribed to Nokia Life Health channels. Behavior change will be assessed by pre-post comparisons in those who received the text messages as well as those (controls) who did not.
Trial website
Trial related presentations / publications
Late breaking abstract and poster presented at World Diabetes Congress, December 2013.
http://arogyaworld.org/wp-content/uploads/2013/12/IDF_2013_mDiabetes_Poster.pdf
Public notes

Contacts
Principal investigator
Name 54842 0
Dr Monika Arora
Address 54842 0
Monika Arora, Ph.D.
Director: Health Promotion
&
Adjunct Associate Professor
Public Health Foundation of India
ISID Campus
4 Institutional Area
Vasant Kunj
New Delhi – 110070


Country 54842 0
India
Phone 54842 0
Phone: +91 11 49566000;
Fax 54842 0
Fax: +91 11 49566063,
Email 54842 0
Monika.arora@phfi.org
Contact person for public queries
Name 54843 0
Dr Nalini Saligram
Address 54843 0
Arogya World
23W651 Hobson Road
Naperville IL 60540
Country 54843 0
United States of America
Phone 54843 0
+1 630 637 8923
Fax 54843 0
Email 54843 0
nalini@arogyaworld.org
Contact person for scientific queries
Name 54844 0
Dr Sandhya Ramalingam
Address 54844 0
34B, Dream Meadows Layout,
ITPL Road Bangalore - 560 0066
Country 54844 0
India
Phone 54844 0
+91 988 606 1600
Fax 54844 0
Email 54844 0
sandhya@arogyaworld.org

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary