| CTRI Number |
CTRI/2020/03/024327 [Registered on: 27/03/2020] Trial Registered Prospectively |
| Last Modified On: |
28/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Prevention of Type 2 diabetes and Cardiovascular diseases using digital applications. |
|
Scientific Title of Study
|
Digital Interventions for Health Promotion and Prevention of T2D and CVD in South Asians. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R M Anjana |
| Designation |
Vice President |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
No 4, Conran Smith Road,
Gopalapuram,
Chennai
Chennai
TAMIL NADU
600086
India |
| Phone |
044-43968888 |
| Fax |
044-28350935 |
| Email |
dranjana@drmohans.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ranjani Harish |
| Designation |
Senior Scientist and Head, Translational Research Department |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
No 4, Conran Smith Road,
Gopalapuram,
Chennai
Chennai
TAMIL NADU
600086
India |
| Phone |
044-43968888 |
| Fax |
044-28350935 |
| Email |
drranjanih@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ranjani Harish |
| Designation |
Senior Scientist and Head, Translational Research Department |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
No 4, Conran Smith Road,
Gopalapuram,
Chennai
TAMIL NADU
600086
India |
| Phone |
044-43968888 |
| Fax |
044-28350935 |
| Email |
drranjanih@gmail.com |
|
|
Source of Monetary or Material Support
|
| NIHR GHRU
Imperial College London, School of Public Health St Mary’s Campus W2 1PG, United Kingdom |
|
|
Primary Sponsor
|
| Name |
NIHR GHRU |
| Address |
Imperial College London, School of Public Health St Mary’s Campus W2 1PG, United Kingdom |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr RM Anjana |
Dr. Mohans Diabetes Specialities Centre and Madras Diabetes Research Foundation |
No 4, Conran Smith Road,
Gopalapuram,
Chennai - 600 086
Chennai
TAMIL NADU |
43968888
28350935
dranjana@drmohans.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MADRAS DIABETESResearch 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 25 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mobile health application |
The participants will receive an access to a lifestyle intervention program in the form of an android smart phone app- which will teach participants about healthy eating, weight loss, exercise, diabetes prevention and healthy living phone application. |
| Comparator Agent |
N/A |
N/A |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants having a moderate to high IDRS (a score of 30 and above) |
|
| ExclusionCriteria |
| Details |
Individuals with known diabetes or any other contra indications that would not permit them to follow lifestyle prescriptions. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To provide a robust evidence base for efficient, effective and scalable m-health interventions to prevent T2D and CVD amongst South Asians |
At the end of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study weight loss and/or inch loss and track behaviour change for a period of 4 months. |
At the beginning and end of he study |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="610" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/04/2020 |
| Date of Study Completion (India) |
31/01/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Study Purpose: This study aims to prevent type 2 diabetes and cardiovascular diseases through digital mobile apps by encouraging lifestyle changes. As part of the study, we aim to test the effectiveness of various mobile phone applications in the primary prevention of diabetes.
Specific objectives of the study are as follows: 1. Identify and evaluate currently available mobile applications for prevention of T2D and CVD amongst South Asians using the Mobile App Rating Scale (MARS) tool. 2. Develop two applications (apps) locally in association with an app developer. 3. Pilot Test the two newly developed applications and one or two applications from the commercial sector against primary end-points such as app usability, preferences, engagement, along with secondary end points like weight loss and/or inch loss and change in behaviour (step count/calorie intake etc.)
From the pilot study, we hope to develop a novel innovative application that can be tested on a larger scale in a randomised clinical trial mode. We have built this as our future work once we complete the pilot study. Overall we expect that the digital study will provide a robust evidence base for efficient, effective and scalable m-health interventions to prevent T2D and CVD amongst South Asians
|