| CTRI Number |
CTRI/2024/11/076184 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
04/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
A study on prevention of Type 2 Diabetes Mellitus (T2DM) among prediabetes steel plant employees |
|
Scientific Title of Study
|
"“EFFECTIVENESS OF NURSE-LED INTERVENTION PACKAGE (NLIP) ON KNOWLEDGE, ATTITUDE, EXPRESSED PRACTICE AND BIO-PHYSIOLOGICAL PARAMETERS REGARDING PREVENTION OF TYPE-2 DIABETES MELLITUS (T2DM) AMONG PREDIABETIC EMPLOYEES OF ROURKELA STEEL PLANT(RSP) ODISHA,INDIA". |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nabanita Jena |
| Designation |
Vice Principal |
| Affiliation |
Nurses Training Institute IGH RSP SAIL |
| Address |
Vice Principal Office
Nurses Training Institute
Ispat General Hospital
Rourkela Steel Plant
Rourkela
Sundargarh
ORISSA
769005
India |
| Phone |
9437247529 |
| Fax |
|
| Email |
nabanitajena@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr A Maria Therese |
| Designation |
Vice Principal |
| Affiliation |
MTPG&RIHS |
| Address |
College Of Nursing
MTPG&RIHS
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9894141223 |
| Fax |
|
| Email |
dr.maria163@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sushil Kumar |
| Designation |
Consultant, Medicine |
| Affiliation |
RSP,SAIL |
| Address |
Ispat General Hospital
RSP
SAIL
Sundargarh
ORISSA
769005
India |
| Phone |
8895500765 |
| Fax |
|
| Email |
skumar.dr90@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nurses Training Institute
Ispat General Hospital
Rourkela Steel Plant
ROURKELA
Odisha
India
Pincode 769005 |
|
|
Primary Sponsor
|
| Name |
Nabanita Jena |
| Address |
Nurses Training Institute
Ispat General Hospital
Rourkela
Odisha
India
Pincode 769005 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Nabanita Jena |
Ispat General Hospital, Rourkela Steel Plant |
Room no -8, Medicine OPD,Endocrinology department,Rourkela-769005
Sundargarh
ORISSA |
9437247529
nabanitajena@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ISTITUTIONAL REVIEW BOARD,ISPAT GENERAL HOSPITAL, ROURKELA, ODISHA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E08-E13||Diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Nurse Led Intervention Package(NLIP) |
A structured educational and counselling session will be prepared by the investigator to educate the Prediabetic Employees. A Video for 35- 40 minutes on prevention of Diabetics will be developed . The education focused on the followings -assessment, diagnosis, life style management like diet, physical activity (weight control measures and exercise), quite smoking and restricting alcohol consumption with regard to prevention of Type 2 Diabetes Mellitus. Counselling will be given on any personal issues and doubts will be clarified so that clients will understand the prevention of Diabetes.
At the end of the 30th day, 60th day and 90th day the post test 1, 2, 3 will be carried out to assess the level of knowledge, Attitude, Practice among the Prediabetes RSP employees with the help of same tool.
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Employees of Rourkela Steel Plant who
Were in the age group of 30- 60 years
Had clinically diagnosed with pre diabetes (medical record showing FBS more than 100 to 125 mg/dl, HbA1c 5.7 to 6.5)
Had body weight [over weight (BMI greater than or equal to 25) or obese (BMI greater than or equal to 30)]
Understand English or Local language
Willing to participate in the study
Present during the data collection |
|
| ExclusionCriteria |
| Details |
Employee with type 1, type 2 and gestational diabetes.
People with severe cognitive impairment or physical impairment and terminally ill people.
Had evidence of a serious medical illness.
|
|
|
Method of Generating Random Sequence
|
Other |
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Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effectiveness of Nurse-Led Intervention Package (NLIP) on knowledge, Attitude, expressed practice and Bio physiological parameters regarding prevention of Type 2 Diabetes Mellitus among Prediabetes employees of Rourkela Steel Plant after intervention in the experimental group. |
1 month, 2 month, 3 months interval data will be collected |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To associate effectiveness of Nurse-Led Intervention Package (NLIP) on knowledge, Attitude, expressed practice and Bio physiological parameters among Prediabetes employees of Rourkela Steel Plant with their selected socio demographic variables |
1 month, 2 month, 3 months interval data will be collected |
| To correlate the post-test knowledge score with Attitude, expressed practice and Bio physiological parameters among Prediabetes employees of Rourkela Steel Plant in the experimental group |
1 month, 2 month, 3 months interval data will be collected |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
07/11/2024 |
| 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)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
Modification(s)
|
Diabetes is one of the main fast-growing Non-communicable Disease (NCD) risk to global public health. Prediabetes is a condition in which individuals have blood glucose levels higher than normal but not high enough to be classified as diabetes. People with prediabetes have an increased risk of Type 2 diabetes. An estimated 34% of adults have prediabetes. Prediabetes is now recognized as a reversible condition that increases an individual’s risk for development of diabetes.. The Nurse-led Intervention Package (NLIP) is educational programme delivered through video assisted teaching on Prediabetes and prevention of T2DM where close involvement of patients and caregivers is encouraged. Researcher will provide education, counselling, guidance and monitor the patient condition regularly in order to prevention of the occurrence of Type 2 Diabetes Mellitus. The researcher, from her experience observed that many employees of Rourkela Steel Plant, Odisha diagnosed as Prediabetes and found that they are not following healthy life style like not monitoring the blood glucose level regularly, not taking balance diet, not doing physical activity regularly, not maintaining normal BMI and not adhering to the treatment strategies properly. Due to these unhealthy habits finally, they are developing type 2 Diabetes and experiencing its severe complications.
Developing Nurse-led Intervention package (NLIP) can help people to manage their Prediabetes condition and reduce the risk of developing T2DM and its complications. A Nurse-led Intervention package (NLIP) can be cost effective and efficient way to improve patient outcome.
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