| CTRI Number |
CTRI/2025/12/099435 [Registered on: 18/12/2025] Trial Registered Prospectively |
| Last Modified On: |
11/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A study to improve blood pressure and healthy habits among industrial workers using World Health Organization guidelines. |
|
Scientific Title of Study
|
Effectiveness of WHO PEN- Guided Life style Intervention on Blood Pressure, Health Behaviors and Medication Adherence among Industrial Workers with Hypertension in Hosur: 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 Mounika V |
| Designation |
Junior Resident |
| Affiliation |
St. Peter’s Medical College, Hospital and Research Institute, Hosur |
| Address |
St. Peter’s Medical College, Hospital and Research Institute, Hosur
Dr MGR Nagar, Near AERI Campus, Opp SIPCOT –II,Hosur – 635130, Krishnagiri District
Dharmapuri
TAMIL NADU
635130
India |
| Phone |
8300110606 |
| Fax |
|
| Email |
vsmounika@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naresh Kumar S J |
| Designation |
Professor & HoD |
| Affiliation |
St. Peter’s Medical College, Hospital and Research Institute, Hosur |
| Address |
St. Peter’s Medical College, Hospital and Research Institute, Hosur
Dr MGR Nagar, Near AERI Campus, Opp SIPCOT –II,Hosur – 635130, Krishnagiri District
Dharmapuri
TAMIL NADU
635130
India |
| Phone |
9986902478 |
| Fax |
|
| Email |
naresh17771@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mounika V |
| Designation |
Junior Resident |
| Affiliation |
St. Peter’s Medical College, Hospital and Research Institute, Hosur |
| Address |
St. Peter’s Medical College, Hospital and Research Institute, Hosur
Dr MGR Nagar, Near AERI Campus, Opp SIPCOT –II,Hosur – 635130, Krishnagiri District
Dharmapuri
TAMIL NADU
635130
India |
| Phone |
8300110606 |
| Fax |
|
| Email |
vsmounika@gmail.com |
|
|
Source of Monetary or Material Support
|
| St. Peters Medical College, Hospital and Research Institute
Dr MGR Nagar, Near AERI Campus, Opp SIPCOT –II,
Hosur – 635130, Krishnagiri District, Tamil nadu, India |
|
|
Primary Sponsor
|
| Name |
St. Peter’s Medical College, Hospital and Research Institute, Hosur |
| Address |
St. Peter’s Medical College, Hospital and Research Institute, Hosur
Dr MGR Nagar, Near AERI Campus, Opp SIPCOT –II,Hosur – 635130, Krishnagiri District |
| Type of Sponsor |
Other [Government aided Medical college and Hospital] |
|
|
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 Mounika V |
St. Peter’s Medical College, Hospital and Research Institute, Hosur |
Department of Community Medicine , 3rd Floor , Acedemic Block, St. Peter’s Medical College, Hospital and Research Institute, Hosur
Dr MGR Nagar, Near AERI Campus, Opp SIPCOT –II,Hosur – 635130, Krishnagiri District
Dharmapuri
TAMIL NADU |
08300110606
vsmounika@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Routine Health Education |
The control group will receive routine health education other than the WHO PEN protocol. This will consist of general lifestyle advice on balanced diet, regular physical activity, reduction of sedentary lifestyle and stress delivered through standard PowerPoint presentations in the native language in small group sessions. These sessions will also be scheduled during work break times. No personalized counseling or digital reinforcement (via SMS or WhatsApp) will be provided to the control group.The first session will take place at the baseline visit, during which all required data will be collected and blood pressure will be measured. Follow-up counseling sessions will be conducted at 2 months, 4 months, and 6 months, with BP measured at each visit. The final assessment at 6 months will include reassessment of all baseline parameters.
|
| Intervention |
Structured, in-person lifestyle counseling based on WHO PEN guideline |
The intervention group will receive structured, in-person lifestyle counseling based on WHO PEN guidelines, delivered by trained healthcare professionals. The first session will take place at the baseline visit, during which all required data will be collected and blood pressure will be measured. Follow-up counseling sessions will be conducted at 2 months, 4 months, and 6 months, with BP measured at each visit. The final assessment at 6 months will include reassessment of all baseline parameters.
Counseling sessions will be conducted in person during work break times and scheduled according to participant’s shift hours and availability, to ensure minimal disruption to routine job responsibilities. Health education will be reinforced using printed handouts and visual aids in their native language. The counseling will focus on dietary advice, physical activity promotion, cessation of tobacco and alcohol use and medication adherence. Additionally, participants will receive weekly reinforcement messages via SMS and WhatsApp throughout the 6-month intervention period.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Blue-collar workers.
Diagnosed with hypertension - BP more than or equal to 140/90 mmHg, regardless of current treatment status.
|
|
| ExclusionCriteria |
| Details |
Individuals with uncontrolled/severe comorbid conditions.
Pregnant/lactating women.
White-collar workers. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Blood Pressure |
Baseline and post 6 months of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| changes in dietary practices, physical activity, tobacco/alcohol use, and medication adherence (MMAS-8). |
Baseline and post 6 months of intervention |
|
|
Target Sample Size
|
Total Sample Size="352"
Sample Size from India="352"
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)
|
22/12/2025 |
| 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="2"
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
|
This quasi-experimental study aims to evaluate the effectiveness of a WHO PEN–guided lifestyle intervention on blood pressure control, health behaviors, and medication adherence among industrial workers with hypertension in Hosur, Tamil Nadu. Two large industries (>10,000 workers) will be selected from SIPCOT Phase I and II using multistage stratified sampling. One industry will be assigned to the intervention group and the other to the control group by simple randomization (coin toss).
A total of 358 hypertensive workers (179 per group) will be selected through simple random sampling from occupational health records. The intervention group will receive structured WHO PEN-based lifestyle counseling at baseline, 2, 4, and 6 months, along with weekly reinforcement messages. The control group will receive routine health education practiced in the industry.
Primary outcome: change in systolic and diastolic blood pressure over 6 months.
Secondary outcomes: changes in dietary practices, physical activity, tobacco/alcohol use, and medication adherence (MMAS-8).
Blood pressure, anthropometry, and lifestyle parameters will be assessed at baseline and at 6 months. Data will be analyzed using paired/unpaired t-tests, chi-square tests, and repeated measures ANOVA. The study aims to generate evidence on integrating WHO PEN lifestyle counseling into industrial health systems to improve hypertension management. |