| CTRI Number |
CTRI/2026/01/100028 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
18/06/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Personalized lifestyle prescription (Exercise and Diet) for Indians with Cardio metabolic Diseases |
|
Scientific Title of Study
|
Development and Validation of a Novel, Third-Generation Lifestyle (Exercise and Nutrition) Prescription for Precision Medicine in Indians with cardio metabolic diseases (DEVELOP Study). |
| Trial Acronym |
DEVELOP Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pranathi Racha |
| Designation |
Assistant Professor |
| Affiliation |
St. Johns Medical College |
| Address |
3rd floor, Department of Physiology, Golden Jubilee Block, St. Johns Medical College, Sarjapur Road, Bangalore- 560034, Karnataka.
Bangalore
KARNATAKA
560034
India |
| Phone |
9620194601 |
| Fax |
|
| Email |
pranathi.r@stjohns.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Denis Xavier |
| Designation |
Professor and Head |
| Affiliation |
St. Johns Research Institute |
| Address |
1st Floor,Department of Pharmacology St Johns Medical College Head, Division of Clinical Research and training St. Johns Research Institute Koramangala
Bangalore India
Bangalore
KARNATAKA
560034
India |
| Phone |
9886126801 |
| Fax |
|
| Email |
denis.xavier@stjohns.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pranathi Racha |
| Designation |
Assistant Professor |
| Affiliation |
St. Johns Medical College |
| Address |
3rd floor, Department of Physiology, Golden Jubilee Block, St. Johns Medical College, Sarjapur Road, Bangalore- 560034, Karnataka
Bangalore
KARNATAKA
560034
India |
| Phone |
9620194601 |
| Fax |
|
| Email |
pranathi.r@stjohns.in |
|
|
Source of Monetary or Material Support
|
| ICMR Small Assistance Grant |
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
V. Ramalingaswami Bhawan, Post Office 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 = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pranathi Racha |
St. Johns Medical College Hospital |
Sarjapur Road, Koramangala, Bengaluru, Karnataka 560034.
Bangalore
KARNATAKA |
9620194601
pranathi.r@stjohns.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| St Johns Medical College Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
No risk factors for cardio metabolic diseases. |
| Patients |
(1) ICD-10 Condition: E889||Metabolic disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Healthy volunteers and Cardio Metabolic patients (stages 0-4) (table 1) (2), aged 18-60 years, sedentary to moderately active (PAL 2) 34, willing to adapt to exercise and provide informed consent. |
|
| ExclusionCriteria |
| Details |
Contraindications to structured exercise (e.g., uncontrolled
hypertension, unstable angina), inability to exercise due to conditions like osteoarthritis, or non-compliance risks (e.g., distant residence, cognitive impairment) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Development and validation of a third- generation precision lifestyle prescription (TGPLP) in improving adherence to optimal physical activity and diet compared to standard of care |
Baseline and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cost-effectiveness, acceptability, and scalability of third generation precision lifestyle prescription for a larger randomized controlled trial. |
24- 36 months |
|
|
Target Sample Size
|
Total Sample Size="2250"
Sample Size from India="2250"
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
|
N/A |
|
Date of First Enrollment (India)
|
22/01/2026 |
| 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="3"
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 - NO
|
Brief Summary
Modification(s)
|
Cardiometabolic diseases (CMDs) such as hypertension, dyslipidaemia, and type 2 diabetes significantly increase cardio- and cerebrovascular risk. Conventional manually written first-generation lifestyle prescriptions show sub- optimal adherence, while second-generation electronic prescriptions without artificial intelligence (AI) are limited in India. Third-generation lifestyle prescriptions integrate wearable, clinical and physiological parameters, genetic information, and evidence-based guidelines using AI/machine-learning (ML) tools to generate precise, individualised recommendations, an approach unexplored in India. This study proposes the development of a culturally relevant Third-Generation Precision Lifestyle Prescription (TGPLP) that can be customised by treating physicians. Objective 1 is to develop TGPLP using detailed prospective data from 2,000 participants across CMD stages, integrating genetic, wearable, clinical, and lifestyle datasets through AI/ML. Objective 2 is to evaluate the preliminary efficacy of TGPLP on adherence to physical activity and diet over 12 weeks through a pilot randomised controlled trial in 200 particpants. Objective 3 is to assess cost, acceptability, and scalability to inform a future multi-centre RCT. We will Assess physical activity using IPAQ questionnaire instead of SJRI developed PAQ for its wider international acceptance, standardized scoring system, and ease of administration in large clinical studies. |