| CTRI Number |
CTRI/2025/11/097776 [Registered on: 20/11/2025] Trial Registered Prospectively |
| Last Modified On: |
20/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Diabetes Among Young Adults in Coastal Karnataka and How a Community Program Can Help |
|
Scientific Title of Study
|
Prevalence of Diabetes and Effectiveness of a Community-Based Intervention Among Young Adults in Coastal Karnataka: A Mixed Method Study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
George Koshy |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Dept. of Community Medicine, KMC Manipal, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7011525708 |
| Fax |
|
| Email |
george.kmcmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sanjay Kini |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Dept. of Community Medicine, KMC Manipal, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9844616750 |
| Fax |
|
| Email |
sanjay.kb@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
George Koshy |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Dept. of Community Medicine, KMC Manipal, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7011525708 |
| Fax |
|
| Email |
george.kmcmpl2024@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal, MAHE |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College, Manipal |
| Address |
Kasturba Medical College, Madhav Nagar, Manipal, Karnataka, India 576104 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| George Koshy |
Kumbashi |
Kumbashi (Kumbhashi), Kundapura Taluk, Udupi District, Karnataka, India
Udupi
KARNATAKA |
7011525708
george.kmcmpl2024@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Institutional Ethics Committee-1 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ICD-10 CONDITION: E11 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lifestyle intervention package including educational videos, individualized diet plan, physical activity counseling, and regular follow-up for 6 months among newly diagnosed type 2 diabetes patients. |
Educational videos: Short validated videos on diabetes care, diet, and lifestyle, sent at regular intervals via social messaging apps.
Customized diet plan: Individualized according to BMI and eating habits.
Physical activity assessment & promotion: Counseling and self-reported monitoring of physical activity.
Enrollment post observational study
|
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 18 to 40 years
Permanent residents of Kumbashi for at least 1 year
Willing to participate in the study |
|
| ExclusionCriteria |
| Details |
Pregnant women.
Terminally ill individuals.
People with psychiatric diagnoses who cannot comprehend the questionnaire. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in HbA1C levels among newly diagnosed high-risk individuals with Type 2 Diabetes after lifestyle intervention. |
BASELINE (FROM MARCH 2025) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Risk factor analysis for type 2 diabetes (age, abdominal obesity, physical activity, family history, BMI, diet, alcohol/tobacco use, stress, blood pressure, etc.).
Prevalence of newly diagnosed type 2 diabetes using IDRS screening + GRBS/CBG testing.
Effectiveness of lifestyle intervention (educational video, customized diet plan, physical activity assessment, medication support) in improving glycemic control among high-risk/undiagnosed diabetics |
6 months after intervention |
|
|
Target Sample Size
|
Total Sample Size="1280"
Sample Size from India="1280"
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)
|
01/12/2025 |
| 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="2"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This community-based mixed-method study will be conducted among young adults (18–40 years) in Kumbashi, coastal Karnataka. The study has two components. First, a cross-sectional survey will estimate the prevalence of type 1 and type 2 diabetes and assess risk factors using tools such as the Indian Diabetes Risk Score (IDRS), anthropometry, blood pressure, stress scale, and blood glucose testing. Second, a prospective single-arm interventional study will be carried out among newly diagnosed type 2 diabetes patients identified during the survey. These participants will receive a lifestyle intervention package consisting of educational videos, individualized diet plans, physical activity counselling, and regular follow-up for six months. The primary outcome will be change in HbA1C levels after six months of intervention. The study aims to generate evidence on the burden of diabetes in young adults and evaluate the effectiveness of a scalable community-based intervention for diabetes control and prevention. |