FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2015/07/006011 [Registered on: 16/07/2015] Trial Registered Prospectively
Last Modified On: 06/10/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A reality TV based diabetes prevention program using mobile phone technology 
Scientific Title of Study   MOBILE HEALTH TECHNOLOGY FOR THE PREVENTION OF TYPE 2 DIABETES 
Trial Acronym  mDiab 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr V Mohan 
Designation  President and Chief of Diabetes Research, Diabetology and Epidemiology 
Affiliation  Dr Mohans Diabetes Specialities Centre and Madras Diabetes Research Foundation 
Address  No 6 Conron Smith Road Gopalapuram Chennai

Chennai
TAMIL NADU
600086
India 
Phone  044-43968888  
Fax  28350935  
Email  drmohans@diabetes.ind.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ranjani Harish 
Designation  Sr. Scientist and Head of the Department (Translational Research) 
Affiliation  Dr Mohans Diabetes Specialities Centre and Madras Diabetes Research Foundation 
Address  No 6 Conron Smith Road Gopalapuram Chennai

Chennai
TAMIL NADU
600086
India 
Phone  09940042073  
Fax  28350935  
Email  drranjanih@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ms Shruti Muralidharan 
Designation  Doctoral Student 
Affiliation  Deakin University and Madras Diabetes Research Foundation 
Address  No 6 Conron Smith Road Gopalapuram Chennai

Chennai
TAMIL NADU
600086
India 
Phone  08754089470  
Fax  28350935  
Email  shruti.muralidharan@gmail.com  
 
Source of Monetary or Material Support  
Biotechnology Industry Research Assistance Council (BIRAC) 1st Floor ,MTNL Building ,9 , CGO Complex, Lodhi Road, New Delhi-110003 
 
Primary Sponsor  
Name  Biotechnology Industry Research Assistance Council BIRAC 
Address  1st Floor ,MTNL Building ,9 , CGO Complex, Lodhi Road, New Delhi-110003 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Mr Sidhant Jena  Bangalore  Chief Executive Officer Janacare Inc 84 8th C Main Koramangala 3J Block Bangalore 560034
Bangalore
KARNATAKA 
9871644034

sjena@janacare.com 
Dr V Mohan  Chennai  Director and Chief of Diabetes Research Madras Diabetes Research Foundation No 6 Conron Smith Road Gopalapuram Chennai 600086
Chennai
TAMIL NADU 
044-43968888
28350935
drmohans@diabetes.ind.in 
Dr Nikhil Tandon  New Delhi  Dept. of Endocrinology and Metabolism All India Institute of Medical Sciences (AIIMS) Ansari Nagar New Delhi 110029
South
DELHI 
011-26593433

nikhil_tandon@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee All India Institute of Medical Sciences  Approved 
Madras Diabetes Research Foundation Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Adults above the age of 20 years at risk for Type 2 Diabetes 
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Mobile health application  The participants randomized to this group will receive an access reality TV based lifestyle intervention program in the form of an android smart phone app, which will teach participants about healthy eating, weight loss, and exercise through video lessons for 12 weeks inbuilt in a mobile health smart phone application. 
Comparator Agent  Standard care   The participants randomized to this group will receive standard care which includes a brochure on healthy eating, weight loss, and exercise at baseline. 
 
Inclusion Criteria
Modification(s)  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Android Smartphone users between 20 and 65 years of age
a) BMI greater than or equal to 25 kg/m2 and/or
b) IDRS greater than or equal to 60 and/or
c) IDRS greater than or equal to 40 and BMI greater than or equal to 23 kg/m2 and/or
d) BMI greater than or equal to 23 kg/m2 and random (110–199 mg/dl) (or) fasting (100 to 125 mg/dl) capillary glucose indicating
prediabetes and/or
e) IDRS greater than or equal to 40 and random (110 to 199 mg/dl) (or) fasting (100–125 mg/dl) capillary glucose indicating prediabetes 
 
ExclusionCriteria 
Details  Participants involved in other wellness programs, self reported and newly diagnosed diabetes
Those who have underone any major surgery (especially cardiovascular or bariatric) within the part three years
Pregnancy
Type 1 Diabetes
Cardiovascular disorders, Advanced stage cancer, kidney failure and or on dialysis
Inability to walk and orthopedic disabilities 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
5% weight loss
 
10-12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in cardiometabolic risk factors (waist circumference, blood pressure, serum glucose, lipids and insulin) and behavioral and social variables.  3-4 months and 10-12 months 
 
Target Sample Size   Total Sample Size="1500"
Sample Size from India="1500" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/08/2015 
Date of Study Completion (India) 06/04/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Muralidharan S, Ranjani H, Mohan Anjana R, et al. Engagement and Weight Loss: Results from the Mobile Health and Diabetes Trial. Diabetes Technol Ther. 2019;21(9):507-513. doi:10.1089/dia.2019.0134 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

The proposed study, Mobile Health Technology for the prevention of Type 2 Diabetes (mDiab) is a Randomized Control Trial. It aims to implement and evaluate a Reality TV based lifestyle intervention delivered via a mobile phone application with 1500 people defined as “high risk” randomized to either the reality TV based lifestyle intervention or standard lifestyle counselling at three sites in India namely Chennai, Bengaluru and New Delhi. The research question here is whether lifestyle intervention delivered in the form of a reality based TV show captured as video lessons and delivered via a mobile health (mHealth) application can prevent or delay Type 2 Diabetes in "high risk" population. The “high risk” category in this study is defined as those adults who have one or more of the inclusion criteria. The intervention is in the form of 12 weekly video lessons adapted from the Diabetes Community Lifestyle Improvement Program (D-CLIP), a primary prevention translational trial for diabetes prevention conducted at the MDRF in Chennai, India and to be delivered via android smart phones. The primary outcome will look at a 5% weight loss at 10-12 months. The secondary outcomes will look at improvement in cardio metabolic risk factors (waist circumference, blood pressure, plasma glucose, serum lipids and fasting insulin) and behavioral and social variables at 3-4 months and 10-12 months. 

* IDRS is a simplified validated diabetes risk score devised by Dr V Mohan and Colleagues of the Madras Diabetes Research Foundation. It uses the 4 risk factors, age, physical activity, family history and waist circumference to identify the risk for type 2 diabetes in the Indian population.

 
Close