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CTRI Number  CTRI/2022/01/039818 [Registered on: 28/01/2022] Trial Registered Prospectively
Last Modified On: 16/05/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study on behavioural risk factors of hypertension among schoolteachers. 
Scientific Title of Study   A study on behavioural risk factors associated with hypertension and its knowledge among schoolteachers in Palakkad district, Kerala. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Avani Murali 
Designation  Post graduate student(MPH) 
Affiliation  Prasanna school of Public Health 
Address  Room no-62 Department of Health Policy, Prasanna school of Public Health, Manipal Academy of Higher Education(MAHE),Madhav Nagar, Eshwar Nagar, Manipal, Karnataka.

Udupi
KARNATAKA
576104
India 
Phone  8792502604  
Fax    
Email  avani.murali@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Kumar Sumit 
Designation  Assistant Professor- Senior scale 
Affiliation  Prasanna school of Public Health 
Address  Room no-53 Department of Health Policy, Prasanna school of Public Health, Manipal Academy of Higher Education(MAHE),Madhav Nagar, Eshwar Nagar, Manipal, Karnataka.

Udupi
KARNATAKA
576104
India 
Phone  8867620088  
Fax    
Email  kumar.sumit@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Kumar Sumit 
Designation  Assistant Professor- Senior scale 
Affiliation  Prasanna school of Public Health 
Address  Room no-53 Department of Health Policy, Prasanna school of Public Health, Manipal Academy of Higher Education(MAHE),Madhav Nagar, Eshwar Nagar, Manipal, Karnataka.

Udupi
KARNATAKA
576104
India 
Phone  8867620088  
Fax    
Email  kumar.sumit@manipal.edu  
 
Source of Monetary or Material Support  
Department of Health Policy,Prasanna School of Public Health, Manipal Academy of Higher Education(MAHE), Madhav Nagar, Eshwar Nagar, Manipal, Karnataka-576104 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Mrs Leena G  Palakkad district  Room no-7,Senior Basic School(SBS) Meetna, Palappuram, Ottappalam, Palakkad-679103
Palakkad
KERALA 		 9495981193

leenamurali17009@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Schoolteachers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1) Both male and female schoolteachers of Government and Government aided schools in Palakkad district.
2) Primary and High school teachers in the age group of 30-55 years.
3) Those who are having a minimum work experience of one year. 
 
ExclusionCriteria 
Details  1) Contractual attendants
2) Part-time teachers
3) Those who are on leave at the time of data collection. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the behavioural risk factors associated with hypertension among the schoolteachers.  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To understand the risk factors leading to hypertension among schoolteachers and also to understand the knowledge related to this among them. The findings from the study can serve as baseline data for comparison with similar studies from other parts of the country.  12 weeks 
 
Target Sample Size   Total Sample Size="211"
Sample Size from India="211" 
Final Enrollment numbers achieved (Total)= "211"
Final Enrollment numbers achieved (India)="211" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/02/2022 
Date of Study Completion (India) 25/03/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Hypertension or elevated blood pressure is a major cause of premature death worldwide. The global prevalence of hypertension has been on the rise and World Health Organization (WHO) has estimated that currently more than a billion people have hypertension and two-thirds of them are in low- and middle-income countries.  The teaching profession is a highly stressful occupation due to enhanced psychosocial stress at the workplace. Several studies have reported a susceptibility of teachers to develop hypertension due to work-related risk factors like unhealthy diet, overweight, obesity, and lack of physical activity. The current study aims to assess the behavioural risk factors associated with hypertension among the schoolteachers in Palakkad as well as the hypertension knowledge among them. Nevertheless, the study intends to generate awareness regarding the need for early detection, control, and proper treatment of hypertension among schoolteachers. 
This cross-sectional quantitative study with a sample size of 211, will be conducted among the government and government-aided schoolteachers of the Palakkad district. In order to achieve the study objectives, participants will be interviewed face to face or in case of covid restrictions through a telephonic interview (online method) using a close-ended questionnaire.
The evidence generated through the current study can be used to address the gaps in the control of hypertension among schoolteachers as well as to a large community through them.
 
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