| CTRI Number |
CTRI/2026/03/107141 [Registered on: 30/03/2026] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
A study to see whether WhatsApp messages supporting healthy lifestyle changes can help prevent diabetes among adults at high risk for diabetes in Indian cities |
|
Scientific Title of Study
|
Effectiveness of a digital diabetes prevention initiative in Indian cities: Hybrid type 2 pragmatic cluster-RCT using mHealth (ICMR-DPCI) |
| Trial Acronym |
ICMR-DPCI |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Joshua Chadwick |
| Designation |
Scientist C (Medical) |
| Affiliation |
ICMR-National Institute of Epidemiology, Chennai |
| Address |
Division of Noncommunicable Disease Epidemiology, 2nd Floor,
R-127, Second Main Road,TNHB, Ayapakkam
Chennai
TAMIL NADU
600077
India |
| Phone |
09176270955 |
| Fax |
|
| Email |
joshuachadwick89@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Joshua Chadwick |
| Designation |
Scientist C (Medical) |
| Affiliation |
ICMR-National Institute of Epidemiology, Chennai |
| Address |
Division of Noncommunicable Disease Epidemiology, 2nd Floor,
R-127, Second Main Road,TNHB, Ayapakkam
Chennai
TAMIL NADU
600077
India |
| Phone |
09176270955 |
| Fax |
|
| Email |
joshuachadwick89@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Joshua Chadwick |
| Designation |
Scientist C (Medical) |
| Affiliation |
ICMR-National Institute of Epidemiology, Chennai |
| Address |
Division of Noncommunicable Disease Epidemiology, 2nd Floor,
R-127, Second Main Road,TNHB, Ayapakkam
Chennai
TAMIL NADU
600077
India |
| Phone |
09176270955 |
| Fax |
|
| Email |
joshuachadwick89@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research (ICMR),
V. Ramalingaswami Bhawan,
P.O. Box No. 4911
Ansari Nagar,
New Delhi - 110029,
India |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research (ICMR) |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911
Ansari Nagar, New Delhi - 110029, India |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Suyesh Shrivastava |
Primary Health Centres (PHC) |
Govind Das District Hospital (Victoria Hospital),
Badi Omti, Ganjipura Road,
Jabalpur,
Madhya Pradesh-482 002
Jabalpur
MADHYA PRADESH |
9131642464
dr.ssuyesh@gmail.com |
| Dr Joshua Chadwick |
Urban primary health centres (UPHC) |
Greater Chennai Corporation (Public Health Department),
Ripon Building, Chennai-600003.
TAMIL NADU
Chennai
TAMIL NADU |
9176270955
joshuachadwick89@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, ICMR-NIRTH, Jabalpur |
Approved |
| Institutional Human Ethics Committee ICMR-National Institute of Epidemiology |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R730||Abnormal glucose, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Arm |
All participants are provided with a health education booklet containing information on symptoms, complications, and risk factors of T2DM with the recommended levels for primary prevention. |
| Intervention |
ICMR-DPCI |
The ICMR-DPCI intervention is a fully automated, WhatsApp-based self-management support programme for diabetes prevention. After enrolment, participants receive approximately 100–120 pre-scheduled, theme-based multimedia messages over a period of six months. The messages include text, images, audio, and video content and are delivered without real-time human involvement. The content focuses on lifestyle modification, including healthy diet, physical activity, sleep, stress management, and other behaviours relevant to diabetes prevention. The duration of intervention is for 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
64.00 Year(s) |
| Gender |
Both |
| Details |
- Permanent residents of the selected zone
- Indian Diabetes Risk Score (IDRS) greater than 60 and-or Community Based Assessment Checklist (CBAC) score greater than 4
- Individuals with prediabetes with HbA1c from 5.7 to 6.4
- Willingness to provide informed consent
- Ownership of smartphone with internet access or we will include those who can
reliably access a smartphone via a family member for the intervention period.
- Willing and able to answer calls and read multimedia messages in Tamil, Hindi, or
English as part of the study. |
|
| ExclusionCriteria |
| Details |
- Patients with type 1 diabetes mellitus and type 2 diabetes mellitus (self-reported) for prediabetes (objective)
- Patients with learning difficulties or vision and/or hearing impairments without a
caregiver, making it impossible to use a mobile phone
- Malignancy or life-threatening disease with death probable in 4 years
- Inability or unwillingness of individual or legal guardian to give written informed consent
- Pregnant women |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary outcome is the progression to diabetes which is defined as HbA1c greater than or equal to 6.5 percent at any follow up visit or in another care setting with American Diabetes Association (ADA) criteria for diagnosis of diabetes.
|
Baseline, 6 months and 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcomes include the proportion of participants achieving HbA1c less than or equal to 6.4 percent, blood pressure, blood lipids, body weight, dietary intake, physical activity, acceptability of intervention and sedentary behaviour measured using valid and reliable self-report questionnaires. |
Baseline and follow up at 12 months. |
|
|
Target Sample Size
|
Total Sample Size="3532"
Sample Size from India="3532"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/09/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [joshuachadwick89@gmail.com].
- For how long will this data be available start date provided 31-08-2028 and end date provided 01-09-2033?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Rationale India has more than 101 million individuals diagnosed with type 2 diabetes mellitus (T2DM). There is an urgent need to focus on preventing or delaying the onset of this condition. We propose a study, Digital-Diabetes Prevention and Control Initiative (ICMR-DPCI) a first implementation trial to evaluate the effectiveness of lifestyle modification delivered through WhatsApp (mHealth) for the prevention of diabetes among individuals with higher risk for developing diabetes within public primary health facilities of Chennai, Tamil Nadu and Jabalpur, Madya Pradesh, India.
Methods 72 primary health centres (PHCs) will be randomised to the intervention arm or control arm in Chennai and Jabalpur, India, beginning with a dual step screening for individuals aged 18 to 64 based on CBAC or IDRS scores and HbA1c levels. Participants in the control arm will receive a health education booklet detailing the symptoms, complications, and risk factors associated with T2DM, emphasising primary prevention strategies. Participants in the intervention arm receive a fully automated self-management support programme delivered twice a week for 12 months, with 100-120 messages, supported by Chatbot to motivate and support them in engaging in the behaviours needed to prevent progression to diabetes successfully. Follow-up assessments will be done at 12 months. The primary outcome is incidence of T2DM. Secondary outcomes include behavioural, clinical, quality of life and biochemical measures (HbA1c and blood lipids). An economic evaluation will also be conducted.
Expected outcome Findings from this study will enhance policies and practices related to lifestyle modification initiatives aimed at diabetes prevention in India. |