| CTRI Number |
CTRI/2025/11/096995 [Registered on: 06/11/2025] Trial Registered Prospectively |
| Last Modified On: |
03/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of a health education programme on reducing lifestyle-related disease risks among fishermen in rural Puducherry. |
|
Scientific Title of Study
|
An embedded experimental model to assess the effectiveness of a health promotion intervention on non-communicable disease risk factors among fishermen in rural Puducherry – A one-phase approach. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NIJANTHAN |
| Designation |
MD Community Medicine |
| Affiliation |
Aarupadai Veedu Medical College |
| Address |
Department of community medicine
Aarupadai veedu medical college,
Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9344769765 |
| Fax |
|
| Email |
nijanthanduraisamy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Nishanthini.N |
| Designation |
Professor |
| Affiliation |
Aarupadai Veedu Medical College |
| Address |
Department of community medicine
Aarupadai veedu medical college,
Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9894953477 |
| Fax |
|
| Email |
nishanthini.natarajan@avmc.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
NIJANTHAN |
| Designation |
MD Community Medicine |
| Affiliation |
Aarupadai Veedu Medical College |
| Address |
Department of community medicine
Aarupadai veedu medical college,
Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9344769765 |
| Fax |
|
| Email |
nijanthanduraisamy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Health Research (DHR),
Ministry of Health and Family Welfare, Government of India,
1st Floor, IRCS Building,
1, Red Cross Road,
New Delhi – 110001, India. |
|
|
Primary Sponsor
|
| Name |
Nijanthan D |
| Address |
Department of Community Medicine, Aarupadai Veedu Medical College and Hospital, Kirumampakkam, Puducherry – 607402 |
| Type of Sponsor |
Other [Myself] |
|
|
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 Nijanthan D |
Aarupadai Veedu Medical College & Hospital (AVMC&H) |
Department of Community Medicine,
Aarupadai Veedu Medical College & Hospital,
Kirumampakkam, Bahour Commune Panchayat,
Puducherry – 607402,
India.
Pondicherry
PONDICHERRY |
9344769765
nijanthanduraisamy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee, Aarupadai Veedu Medical College & Hospital (AVMC), Puducherry |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
tobacco use (F17), alcohol use (F10), unhealthy diet (Z72.4), physical inactivity (Z72.3), obesity (E66),stress-related disorders (F43), and sleep disorders (G47) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Routine Health Advice (Control Group) |
Participants in the control group receive only routine health advice provided through existing PHC services, without structured health-promotion sessions. Usual IEC materials available at PHC are used. No follow-up educational sessions are conducted during the study period.
Total duration of comparator (follow-up): 3 months. |
| Intervention |
WHO PEN Protocol 2 Health Promotion Intervention |
Structured health-education and counselling sessions based on WHO PEN Protocol 2 (Health education and counselling on healthy behaviours). Participants receive modules on tobacco cessation, alcohol moderation, healthy diet, physical activity, stress management, and sleep hygiene. The intervention includes group education, demonstrations, visual aids.
Primary focus – reduction of NCD risk factors (blood pressure, BMI, tobacco/alcohol use, physical activity, diet).
Total duration of intervention: 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
Fishermen with NCD risk factors
Fishermen above 18 years of age to 65 years
Fishermen who are permanent residence of the study area
|
|
| ExclusionCriteria |
| Details |
Fishermen who are not actively engaged in fishing for past one year
Fishermen who were sick during baseline data collection
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in mean non-communicable disease (NCD) risk-factor profile among fishermen following a WHO PEN Protocol 2-based health-promotion intervention. Indicators include systolic and diastolic blood pressure, body mass index (BMI), tobacco and alcohol use status, fruit and vegetable intake, physical-activity levels, and stress score (PSS-10) |
Baseline and 6 months post-intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in mean Pittsburgh Sleep Quality Index (PSQI) score among participants. |
Baseline and 3 months |
| Change in knowledge and attitude scores regarding healthy lifestyle practices. |
Baseline and 3 months |
|
|
Target Sample Size
|
Total Sample Size="116"
Sample Size from India="116"
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)
|
17/11/2025 |
| 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="6"
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
|
This interventional community-based study aims to assess the effectiveness of a health promotion intervention based on WHO PEN Protocol 2 in reducing non-communicable disease (NCD) risk factors among fishermen in rural Puducherry. The study follows a one-phase embedded experimental design with two groups – intervention and control. A total of 116 adult fishermen aged 18–65 years will be enrolled, with 58 participants in each arm. The intervention group will receive structured health education and counselling sessions on tobacco cessation, alcohol moderation, healthy diet, physical activity, stress management, and sleep hygiene. The control group will receive routine health advice through existing PHC services. Pre and post-intervention assessments will be carried out using standardized tools – WHO STEPS questionnaire (for risk factors), GPAQ (for physical activity), PSS-10 (for stress), and PSQI (for sleep quality). Anthropometric and blood pressure measurements will be taken using standard methods. The primary outcome will be the change in mean NCD risk-factor profile after three months of intervention. Secondary outcomes include improvement in sleep quality and knowledge regarding healthy lifestyle practices. The study will be conducted at Veerampattinam village, under the field practice area of Aarupadai Veedu Medical College and Hospital, Puducherry. Ethical clearance has been obtained from the Institutional Human Ethics Committee (ECR/847/INST/PY/2016/RR-20). |