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
|
|
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
|
|
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. |