| CTRI Number |
CTRI/2026/01/102269 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
22/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Behavioral |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A study to assess the effect of a community-based intervention programme on knowledge, perception, lifestyle and biochemical parameters among diabetic adults |
|
Scientific Title of Study
|
Effectiveness Of Community Driven Diabetic Nephropathy Prevention (CDDNP) Package on Knowledge, Perception, Lifestyle and Biochemical parameters among Diabetic Adults |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
CJAYASREE |
| Designation |
PROFESSOR |
| Affiliation |
Tamilnadu Dr MGR Medical University |
| Address |
Room no.3,
Head of the Department,
Community Health Nursing Department,
Omayal Achi College of Nursing,
45, Ambattur Road,
Puzhal
Room no.3,
Head of the Department,
Community Health Nursing Department,
Omayal Achi College of Nursing,
45, Ambattur Road,
Puzhal
Thiruvallur
TAMIL NADU
600066
India |
| Phone |
9840106816 |
| Fax |
|
| Email |
jayasree_type@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
CJAYASREE |
| Designation |
PROFESSOR |
| Affiliation |
Omayal Achi College of Nursing |
| Address |
Room no.3,
Head of the Department,
Community Health Nursing Department,
Omayal Achi College of Nursing,
45, Ambattur Road,
Puzhal
Room no.3,
Head of the Department,
Community Health Nursing Department,
Omayal Achi College of Nursing,
45, Ambattur Road,
Puzhal
Thiruvallur
TAMIL NADU
600066
India |
| Phone |
9840106816 |
| Fax |
|
| Email |
jayasree_type@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
CJAYASREE |
| Designation |
PROFESSOR |
| Affiliation |
Omayal Achi College of Nursing |
| Address |
Room no.3,
Head of the Department,
Community Health Nursing Department,
Omayal Achi College of Nursing,
45, Ambattur Road,
Puzhal
Room no.3,
Head of the Department,
Community Health Nursing Department,
Omayal Achi College of Nursing,
45, Ambattur Road,
Puzhal
Thiruvallur
TAMIL NADU
600066
India |
| Phone |
9840106816 |
| Fax |
|
| Email |
jayasree_type@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Omayal Achi Community Health Centre
1/63, Anna Salai,
Arakkambakkam, Pandeswaram Post, Avadi (IAF)
Chennai-55
Tamilnadu
India |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 S Kanchana |
Villages adopted by Omayal Achi Community Health Centre |
Omayal Achi Community Health Centre,
Arakkambakkam
Avadi
Thiruvallur
TAMIL NADU |
9884046488
kanchana_khan@yahoo.co.in |
| MsAmbika |
Villages adopted by Omayal Achi Community Health Centre |
Omayal Achi Community Health Centre,
Arakkambakkam, Avadi
Thiruvallur
TAMIL NADU |
9944891009
oachc1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INTERNATIONAL CENTRE FOR COLLABORATIVE RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E112||Type 2 diabetes mellitus with kidney complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Community Driven Diabetic Nephropathy Prevention Package |
Structured community-based health education and awareness programme focusing on diabetic nephropathy prevention including lifestyle modification, Tai chi exercise, dietary advice, physical activity, medication adherence and regular screening practicesfor a period of 6 months |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adults who are
Medically diagnosed as Diabetes Mellitus with 5 years of chronicity
Able to understand and speak Tamil or English
Accept and co-operate for the change
Residing in the selected village
|
|
| ExclusionCriteria |
| Details |
Adults who are
Medically diagnosed with Renal diseases
Undergone the same or similar type of structured awareness programme
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of the community-driven diabetic nephropathy prevention package as measured by change in biochemical parameters among diabetic adults (e.g., urine albumin, serum creatinine, Hba1c) |
Baseline, 1st month, 3rd month and 6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Outcome 1:
Change in knowledge regarding diabetic nephropathy prevention among diabetic adults.
Outcome 2:
Change in perception towards diabetic nephropathy prevention.
Outcome 3:
Change in lifestyle practices (diet, physical activity, self-care practices). |
Baseline and 3 months post-intervention and 6th month follow up |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
11/02/2026 |
| 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="0"
Months="8"
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
|
Diabetes mellitus is a major public health problem and diabetic nephropathy is one of its serious complications leading to chronic kidney disease. Early prevention through lifestyle modification, awareness and community participation plays a key role in reducing disease burden. This study aims to assess the effectiveness of a community driven diabetic nephropathy prevention package on knowledge, perception, lifestyle practices and biochemical parameters among diabetic adults. A quasi experimental pre test post test control group design will be adopted among diabetic adults residing in adopted villages of Omayal Achi Community Health Centre. In this package the training to be given to the volunteers from each village and they already have trained volunteers in the aspect of diabetic care. The investigator trains them in the aspect of diabetic nephropathy prevention package. The intervention group will receive a structured community driven prevention package including buzz group teaching, Information, Education and communication by means of PPT, Tai chi exercise demonstration and redemonstration by the study group and family counselling along with the family members in the aspect of intake output chart, plant based diet, self motivation to drink adequate water etc, while the control group will receive routine care. Outcomes will be assessed at baseline and after the intervention period to determine the effectiveness of the prevention package. |