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CTRI Number  CTRI/2024/07/070608 [Registered on: 15/07/2024] Trial Registered Prospectively
Last Modified On: 11/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Behavioral
Nutraceutical 
Study Design  Single Arm Study 
Public Title of Study   heath education on hypertensive and obese residents of m.m.nagar to reduce BMI and control blood pressure 
Scientific Title of Study   Impact of health education on Hypertensive and Obesity patients amongst residents of Maraimalai Nagar Municipality,Chengalpattu District,Tamilnadu,India– A Community Interventional Trial 
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. Adithyan.N 
Designation  M D Community medicine  
Affiliation  SRM Medical College Hospital and Research Centre 
Address  Post Graduate Department of Community Medicine SRM MCH & RC SRM nagar Potheri Kattankullathur

Kancheepuram
TAMIL NADU
603203
India 
Phone  9677649177  
Fax    
Email  dr.adithyan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Roshni Mary Peter 
Designation  M D Community medicine  
Affiliation  SRM Medical College Hospital and Research Centre 
Address  Associate Professor Department of Community Medicine SRM MCH & RC SRM nagar Potheri Kattankullathur

Kancheepuram
TAMIL NADU
603203
India 
Phone  8940091300  
Fax    
Email  roshnimarypeter85@gmail.com  
 
Details of Contact Person
Public Query  
Name  Adithyan  
Designation  M D Community medicine  
Affiliation  SRM Medical College Hospital and Research Centre 
Address  PostGraduate Department of Community Medicine SRM MCH & RC SRM nagar Potheri Kattankullathur

Kancheepuram
TAMIL NADU
603203
India 
Phone  9677649177  
Fax    
Email  dr.adithyan@gmail.com  
 
Source of Monetary or Material Support  
Adithyan Post graduate Department of community medicine SRM Medical College Hospital And Research Centre Srm Nagar, Potheri, Kattankulathur – 603 203 Kancheepuram – Dist 
 
Primary Sponsor  
Name  Adithyan N 
Address  2a/2 kannaiyan street arcot 632503 
Type of Sponsor  Other [self] 
 
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 
dradithyan  SRM Medical College Hospital And Research Centre  Community Medicine Department SRM Medical College Hospital And Research Centre
Kancheepuram
TAMIL NADU 		 9677649177

dr.adithyan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRMIEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I10||Essential (primary) hypertension, (2) ICD-10 Condition: E669||Obesity, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  health education  increase duration of physical activity decrease salt intake do regular checkup regular intake of medications after 3 months so 2 visits one before intervention and other after 3 months 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All adults above 18 years of age with HTN and who were overweight and obese  
 
ExclusionCriteria 
Details  Those who are
Not willing to participate in the study or give consent,
Not available at the time of visits(3 visits)
Planning to move from place of study and non residents of M.M. Nagar
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in Mean Blood Pressure in the Community
 		 12 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in Mean BMI in the Community  10 weeks 
 
Target Sample Size   Total Sample Size="312"
Sample Size from India="312" 
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   Phase 4 
Date of First Enrollment (India)   01/08/2024 
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="0"
Months="3"
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   INTRODUCTION
Overweight and obesity are universally recognized as a risk factor for numerous health conditions such as type 2 diabetes, hypertension, some types of cancer, cardiovascular disease, poor quality of life, functional limitations, and mental health concerns
High blood pressure (BP) is ranked as the third most important risk factor for attributable burden of disease in south Asia (2010) studies showed that the crude stroke prevalence in different parts of India ranged from 44.29 to 559/100,000 persons during the past two decades
Justification
•A rise in trends of diseases related to lifestyle like Hypertension and Obesity in Urban society due  
–Unhealthy food intake
–Decrease in physical activity
–Busy life schedules.
–Decrease intake of home cooked foods
–Unawareness of healthy food habits.
•Not many studies have been done to demonstrate the effect of health education on Blood Pressure and Weight reduction in Chengalpattu district , tamilnadu
Aim and Objectives
To identify and measure Blood pressure & Obesity indices of hypertensive and obesity patients before health education
To Evaluate the Blood pressure & Obesity indices of hypertensive and obesity patients post health education

OUTCOME MEASURES: 
Reduction in Mean Blood Pressure in the Community
Reduction in Mean BMI in the Community
Methodology
Study Design         : Community Interventional Trial
Study area             : SRM Urban Field practice area
Study population : All adults above 18 years of age with Hypertension, Overweight and Obese residing in Maraimalai Nagar municipality ,Chengalpattu district ,Tamilnadu,India.
Study period : 1 year
•Data collection : data of hypertensive and obesity patients will be obtained from family folder of SRM Urban Health Centre . M.M. Nagar
•Sampling method : Simple random sampling
•Eligibility Criteria
–Inclusion criteria:
•All adults above 18 years of age with HTN and who were overweight and obese (BMI>24.9 kg/m2).
•Hypertensive according to JNC 8 2014 of Systolic BP ▁(>)140 mm/hg and/or Diastolic BP ▁(>) 90 mm/hg
•Overweight and Obesity according to WHO and NIH guidelines for Asian individuals define overweight as a BMI - 23 to 24.9 kg/m2 and obesity as a BMI - >25 kg/m2.
•Eligibility Criteria
–Exclusion criteria :
• Those who are
–Not willing to participate in the study or give consent,
–Not available at the time of visits(3 visits)
–Planning to move from place of study and non residents of M.M. Nagar
 
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