| CTRI Number |
CTRI/2025/09/094756 [Registered on: 15/09/2025] Trial Registered Prospectively |
| Last Modified On: |
14/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
Effect of health education on risk factors of diabetes, hypertension and obesity |
|
Scientific Title of Study
|
Effect of health education on risk factors of non-communicable diseases among industrial workers of district Faridabad; 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 Neelam Doley |
| Designation |
junior resident post graduate student |
| Affiliation |
ESIC medical college and hospital faridabad |
| Address |
community medicine
NH-3, K.L. Mehta Road,
Behind B.K. Hospital, New Industrial Town, Faridabad, Haryana, 121001
Faridabad
HARYANA
121001
India |
| Phone |
8133823459 |
| Fax |
|
| Email |
doleyneelam123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mithilesh Kumar |
| Designation |
Associate professor |
| Affiliation |
ESIC medical college and hospital faridabad |
| Address |
community medicine
NH-3, K.L. Mehta Road,
Behind B.K. Hospital, New Industrial Town, Faridabad, Haryana, 121001
Faridabad
HARYANA
121001
India |
| Phone |
9999756351 |
| Fax |
|
| Email |
dr.mithilesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mithilesh Kumar |
| Designation |
Associate professor |
| Affiliation |
ESIC medical college and hospital faridabad |
| Address |
community medicine
NH-3, K.L. Mehta Road,
Behind B.K. Hospital, New Industrial Town, Faridabad, Haryana, 121001
Faridabad
HARYANA
121001
India |
| Phone |
9999756351 |
| Fax |
|
| Email |
dr.mithilesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC Medical College and Hospital,
NH-3, K.L. Mehta Road,
Behind B.K. Hospital, New Industrial Town, Faridabad, Haryana, 121001 |
|
|
Primary Sponsor
|
| Name |
Dr Neelam Doley |
| Address |
community medicine
ESIC Medical College and Hospital,NH-3, K.L. Mehta Road,Behind B.K. Hospital, New Industrial Town, Faridabad, Haryana, 121001 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Mithilesh Kumar |
community medicine
ESIC Medical College and Hospital,NH-3, K.L. Mehta Road,Behind B.K. Hospital, New Industrial Town, Faridabad, Haryana, 121001 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Neelam Doley |
ESIC medical college and hospital |
Community Medicine
Faridabad
HARYANA |
8133823459
doleyneelam123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ESIC medical college and hospital, faridabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
people working in industry |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
health education |
6 months
health education will be given using information, education and communication(IEC) in form of pamphlets, audio visual presentations and health talks in hindi. Text message containing health lifestyle advices will also be send to participanting interventional group and find its effect on blood pressure, blood sugar level, body mass index and body fat percentage |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
For factories;
Factories with more than 500 workers
For workers;
All factory workers of the selected factories who are literate and above age 18.
Workers with mobile phones having text messaging facilities.
Workers who are willing to continue for one year in the selected factory.
All workers willing to participate and who give written consent. |
|
| ExclusionCriteria |
| Details |
Workers diagnosed with cancer, any psychiatric illness, thyroid disorders, chronic
kidney disease, or chronic liver disease.
Workers on steroid therapy.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Participants Random blood glucose, Blood pressure, Body mass index and Body fat percentage will be measured |
At 0 and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Participants Physical activity, alcohol consumption, tobacco use, salt intake, fruits & vegetable intake, oil intake, waist circumference, hip circumference, waist hip ratio & knowledge, attitude & practice will be measured. |
at 0 & 6 months |
|
|
Target Sample Size
|
Total Sample Size="562"
Sample Size from India="562"
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)
|
01/10/2025 |
| 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="1"
Months="0"
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
|
A
quasi-experimental study will be carried out on industrial workers of district Faridabad.
The primary objective is to estimate the effect of six months’ health education
on risk factors of non-communicable disease (Blood pressure, Blood sugar level,
Body mass index and Body fat percentage) among industrial workers in the
intervention group. The secondary objective is firstly to determine the change
in knowledge, attitude and practice related to non-communicable diseases before
and after the intervention among the study participants. Secondly to compare
the change in risk factors for non-communicable diseases between intervention
and control group after the intervention. Thirdly to evaluate the difference in
non-communicable disease parameters in the high-risk group (known
hypertensives, diabetics, obese) before and after the intervention. Two
factories one for intervention group and one for control group will be randomly
selected after obtaining data from regional office on number of workers. The study
will be conducted for a period of 1 year of which 2 months for pre data
collection, 6 months of health education as intervention will be given to
intervention group and general advice will be given to control group, 2 months post
data collection and 2 months of analysis. Based on inclusion and exclusion
criteria a total of 562 workers will be enrolled using consecutive sampling of
which 281 will belong to intervention group and 281 in the control group. Health
education focusing on healthy dietary intake, regular exercise and non-consumption
of alcohol and tobacco will be given in the form information education and communication
(IEC) pamphlet, chart, health talk, audio video presentation in Hindi. The session
will be conducted on the first, third and fifth month. A brief text message
will be given on second, fourth month. The control group will be given general
advice regarding non-communicable disease on the first month. Measurement as
mention in the form for primary and secondary outcome will be taken on first and
sixth month in both groups. Necessary question pertaining to study are prepared.
The data collected will be analysed using SPSS 25. |