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CTRI Number  CTRI/2025/11/096785 [Registered on: 03/11/2025] Trial Registered Prospectively
Last Modified On: 24/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Other (Specify) [TECHNO BASED INTERVENTION]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Individual Based Lifestyle Modification Versus Techno- Based Lifestyle Modification Among Diabetes Mellitus 
Scientific Title of Study   EFFECTIVENESS OF INDIVIDUAL BASED LIFESTYLE MODIFICATION VERSUS TEHNO-BASED LIFESTYLE MODIFICATION INTERVENTION ON SELF-CARE, GLYCEMIC CONTROL, FOOT ULCER RISK AND QUALITY OF LIFE OF PATIENTS WITH DIABETES MELLITUS- A RANDOMIZED CONTROLLED TRIAL. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  JV JEEVITHA 
Designation  Assistant Professor Department of Medical Surgical Nursing 
Affiliation  KMCH COLLEGE OF NURSING 
Address  259 267, post, phase 2, Balaji Nagar, Kalapatti, Coimbatore
259 267, post, phase 2, Balaji Nagar, Kalapatti, Coimbatore
Coimbatore
TAMIL NADU
641048
India 
Phone  8838312572  
Fax  0000  
Email  jeevitha@kmchcon.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Madhavi S 
Designation  Professor cum Principal 
Affiliation  KMCH College of Nursing 
Address  259 267 phase 2 Balaji Nagar Kalapatti Coimbatore 641 048
259 267 phase 2 Balaji Nagar Kalapatti Coimbatore 641 048
Coimbatore
TAMIL NADU
641048
India 
Phone  9444150993  
Fax  000  
Email  principal@kmchcon.ac.in  
 
Details of Contact Person
Public Query  
Name  Madhavi S 
Designation  Professor cum Principal 
Affiliation  KMCH College of Nursing 
Address  259 267 phase 2 Balaji Nagar Kalapatti Coimbatore Tamil Nadu 641 048
259 267 phase 2 Balaji Nagar Kalapatti Coimbatore Tamil Nadu 641 048
Coimbatore
TAMIL NADU
641048
India 
Phone  9444150993  
Fax  0000  
Email  principal@kmchcon.ac.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  JV JEEVITHA 
Address  KMCH College of Nursing 259 and 267 phase II Balaji Nagar Kalapatti post Coimbatore 641048 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
JV Jeevitha  Dr Shankar Dhandapani  Department of Endocrinology and Diabetology Kovai Medical Center & Hospital Avinasi Road, Coimbatore 641014 641014
Coimbatore
TAMIL NADU 		 8838312572
000
jeevitha@kmchcon.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL HUMAN ETHICS COMMITTEE KMCH INSTITUTE OF ALLIED HEALTH SCIENCES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  INDIVIDUAL BASED LIFESTYLE MODIFICATION INTERVENTION AND TECHNO BASED LIFESTYLE MODIFICATION INTERVENTION  Individual Based lifestyle modification Intervention It is a patient centered approach to life style modification. It involves a series of 3 counselling session after routine standardized diabetic education and counselling. It involves extensive assessment, education on self-management including dietary management, medication adherence, foot care and it aims at facilitating of positive coping. The study participants will be monitored in the first month, third month and sixth month. Techno based lifestyle modification intervention The investigator has planned to develop a new diabetic app aims at educating and promoting positive reinforcement and positive behaviour. The participants will be educated about the features of the app and demonstrated on its use while they are attending the outpatient department. This app will have the following features like self-care behaviour which includes dietary choices, caloric counter, exercises, foot care, reminder for medication, weight and height data, positive feedback for an appropriate behaviour. The app will be developed by the investigator in Tamil / English. Before discharge, the patients will be directed to download the app from the Google play store. The participants will be monitored in the first month, third month and sixth month. 
Comparator Agent  STANDARD CARE  It is a hospital based routine care which includes the following of regular medications, insulin administration, diabetic diet and follow up 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients who are diagnosed with Type 2 Diabetes mellitus and with HbA1c 8% and above 8%.
Patients who aged 40-70 yrs.
Both male and female.
Patients who can use android mobile phones with ease.
Patients who could read and understand Tamil or English.
 
 
ExclusionCriteria 
Details  Patients with severe complications like retinopathy, neuropathy, nephropathy.
Patients with peripheral vascular disease, eczema and injury or trauma to foot.
Patients diagnosed with psychiatry illness.
Patients diagnosed with cognitive or visual disturbances.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Self-care practices assessed through the Diabetes Self-Management Questionnaire-Revised.
Self-care, Blood Sugar and HbA1C.
Self-care, Blood Sugar, HbA1C, Foot Ulcer risk assessment through the Diabetic foot risk assessment tool-Knowledge assessment tool, Diabetes Foot care Questionnaire and SINBAD and Quality of Life assessment through the WHOQOL- BREF 26 Item Questionnaire. 		 1st month
3rd month
6th month 
 
Secondary Outcome  
Outcome  TimePoints 
QUALITY OF LIFE  Post Test 3- 6 months – Self-care, Glycemic control, Foot ulcer risk & Quality of life
 
 
Target Sample Size   Total Sample Size="630"
Sample Size from India="630" 
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 3 
Date of First Enrollment (India)   15/05/2026 
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="4"
Months="6"
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  

OBJECTIVES

Primary objective:

1.To determine the effectiveness of individual based lifestyle modification intervention on self-care compliance and glycemic control of patients with type 2 Diabetes mellitus.

2. To evaluate the effectiveness of techno-based lifestyle modification intervention on self-care compliance and glycemic control of patients with type 2 Diabetes mellitus.

3.To compare the effectiveness of individual based lifestyle modification intervention versus Techno-based lifestyle modification intervention on self-care compliance and glycemic control of patients with type 2 Diabetes mellitus.

Secondary objective:

1.To compare the effectiveness of individual based lifestyle modification versus techno-based lifestyle modification intervention on foot ulcer risk and Quality of Life of patients with type 2 Diabetes mellitus.

2.To find out the association between socio demographic, clinical variable with self-care, glycemic control, foot ulcer risk and Quality of Life.

HYPOTHESES

H 1: There will be a significant difference in self-care, glycemic control, foot ulcer risk and quality of life among the patients with type 2 Diabetes mellitus who receive individual based lifestyle modification intervention and those who receive standard care at (P<0.05).

H2. There will be a significant difference in self-care and glycemic control, foot ulcer risk and quality of life among the patients with type 2 Diabetes mellitus who received techno-based lifestyle modification intervention and those who receive standard care at (P<0.05).

H 3: There will be a significant difference in self-care, glycemic control, foot ulcer risk and quality of life of patients with type 2 Diabetes mellitus who receive individual based lifestyle modification intervention and those who receive techno-based lifestyle modification intervention at (P<0.05).

Plan for Data Collection

Formal permission will be obtained from Chairperson, Ethical committee. Patient information sheet will be obtained and informed consent will be obtained. Demographic and clinical data will be extracted from medical records. In study period the individual based and techno-based life style modification intervention will be administered to Experimental Group A and Experimental Group B for 6 months. For Individual based life style modification intervention group, the patients will be assessed using medical history, current medications, lifestyle factors, psychosocial factors and cultural considerations and educated about the monitoring of blood glucose levels, medication adherence, insulin regimens, maintaining of balanced diet, engaging in regular physical activity, foot care and the diabetes complications.

Along with the education, the demonstration will be done regarding the foot care and self- administration of insulin. The counselling session will be conducted twice in the first month of the study period and once in a month in the consequent months.

For the Techno-based life style modification intervention group, a DM app will be developed to monitor the glycemic control, self-care, foot ulcer risk and Quality of Life.


 
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