| CTRI Number |
CTRI/2026/01/101479 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
02/08/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Structured lifestyle framework consisting of diet, physical activity and sleep] |
| Study Design |
Other |
|
Public Title of Study
|
A study to evaluate a structured lifestyle modification program for glycemic control in Type 2 Diabetes |
|
Scientific Title of Study
|
Effectiveness of a Structured Lifestyle Modification Framework on Glycemic Control in Type 2 Diabetes Mellitus: A Quasi-Experimental 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 |
Dr B Dharani |
| Designation |
Assistant Professor |
| Affiliation |
ACS Medical College and Hospital |
| Address |
Department of Physiology,
ACS Medical College and Hospital,
Velappanchavadi,
Chennai – 600077, Tamil Nadu, India
Chennai
TAMIL NADU
600077
India |
| Phone |
8610263796 |
| Fax |
|
| Email |
dharani.physio@acsmch.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B Dharani |
| Designation |
Assistant Professor |
| Affiliation |
ACS Medical College and Hospital |
| Address |
Department of Physiology,
ACS Medical College and Hospital,
Velappanchavadi,
Chennai – 600077, Tamil Nadu, India
TAMIL NADU
600077
India |
| Phone |
8610263796 |
| Fax |
|
| Email |
dharani.physio@acsmch.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr B Dharani |
| Designation |
Assistant Professor |
| Affiliation |
ACS Medical College and Hospital |
| Address |
Department of Physiology,
ACS Medical College and Hospital,
Velappanchavadi,
Chennai – 600077, Tamil Nadu, India
TAMIL NADU
600077
India |
| Phone |
8610263796 |
| Fax |
|
| Email |
dharani.physio@acsmch.ac.in |
|
|
Source of Monetary or Material Support
|
| ACS Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
ACS Medical College and Hospital |
| Address |
ACS Medical College and Hospital,
Velappanchavadi,
Chennai – 600077, Tamil Nadu, India |
| 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 |
| Dr B Dharani |
ACS Medical College and Hospital |
Department of Physiology,
ACS Medical College and Hospital,
Velappanchavadi,
Chennai – 600077, Tamil Nadu, India
Chennai
TAMIL NADU |
8610263796
dharani.physio@acsmch.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACS Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
| Comparator Agent |
NA |
NA |
| Intervention |
Structured lifestyle modification framework |
Structured lifestyle modification framework consisting of structured diet, physical activity and sleep |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged thirty to sixty years with a diagnosis of type two diabetes mellitus for a duration of at least one year
Glycated hemoglobin value between seven percent and ten percent
Stable use of oral antidiabetic medications for the previous three months
Ownership and regular use of a smartphone to enable follow up and monitoring
Willingness to make modifications in dietary habits, sleep patterns, and physical activity behaviours
Willingness to provide written informed consent to participate in the study |
|
| ExclusionCriteria |
| Details |
Current treatment with insulin therapy
Pregnant or lactating women
Presence of comorbid medical conditions or physical limitations that restrict participation in physical activity
History of psychiatric illness or cognitive impairment that may interfere with study compliance
Current enrolment in any other structured lifestyle intervention or weight management programme
Presence of medical contraindications to physical exercise |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in glycaemic control as measured by HbA1c (%) from baseline to 6 months (24 weeks) following the structured lifestyle modification intervention in adults with type 2 diabetes mellitus. |
Baseline, at 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in anthropometric parameters from baseline to 6 months
Change in blood pressure from baseline to 6 months
Change in body composition from baseline to 6 months
Change in HbA1c at 3 months from baseline
Change in quality of life from baseline to 6 months
Adherence, feasibility, and acceptability of the structured lifestyle modification intervention over 6 months |
Baseline, at 3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 1 |
|
Date of First Enrollment (India)
|
02/02/2026 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 quasi-experimental study aims to evaluate the effectiveness of a culturally adapted structured lifestyle modification framework on glycemic control in adults with type 2 diabetes mellitus. Participants will undergo a 6-month intervention focusing on diet, physical activity, and sleep hygiene, with digital follow-up for adherence monitoring. Glycemic control will be assessed using HbA1c at baseline, 3 months, and 6 months. Secondary outcomes include changes in anthropometric measures, blood pressure, body composition, quality of life, and feasibility and acceptability of the intervention. The study seeks to generate evidence for a low-cost, scalable lifestyle intervention suitable for real-world Indian settings. |