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CTRI Number  CTRI/2024/11/076715 [Registered on: 12/11/2024] Trial Registered Prospectively
Last Modified On: 12/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Cluster Randomized Trial 
Public Title of Study   Study to improve cardiovascular health among young adults. 
Scientific Title of Study   Effectiveness of Technology Empowered App on Cardiovascular Health and Health Literacy among young adults studying in health professional colleges of Udupi Taluk, Karnataka- A Cluster Randomized Controlled 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  Charlet Jasmine Vaz 
Designation  Assistant Professor 
Affiliation  Manipal College of Nursing 
Address  Manipal College of Nursing, Manipal Academy of Higher Education, Manipal Madhav Nagar Karnataka India

Udupi
KARNATAKA
576104
India 
Phone  9686379580  
Fax    
Email  charlet.vaz@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Melita Sheilini 
Designation  Associate Professor 
Affiliation  Manipal College of Nursing 
Address  Manipal College of Nursing, Manipal Academy of Higher Education, Manipal Madhav Nagar Karnataka

Udupi
KARNATAKA
576104
India 
Phone  8095976561  
Fax    
Email  shyli.mel@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Melita Sheilini 
Designation  Associate Professor 
Affiliation  Manipal College of Nursing 
Address  Manipal College of Nursing, Manipal Academy of Higher Education, Manipal Madhav Nagar Karnataka

Udupi
KARNATAKA
576104
India 
Phone  8095976561  
Fax    
Email  shyli.mel@manipal.edu  
 
Source of Monetary or Material Support  
Manipal College of Nursing Manipal Academy of Higher Education, Manipal Madhav Nagar-576104 Karnataka,India 
 
Primary Sponsor  
Name  Charlet Jasmine Vaz 
Address  Manipal College of Nursing Manipal Academy of Higher Education Manipal Madhav Nagar 576104 Karnataka 
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 
Dr Melita Sheilini  Manipal Health professional College  Department of Medical Surgical Nursing Manipal College of Nursing MAHE Manipal Room Number 33167
Udupi
KARNATAKA 		 8095976561

shyli.mel@manipal.edu 
 
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  healthy young adults who will be consenting 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Onsite awareness programme  Standard routine care for duration of one year 
Intervention  Technology Empowered App on Cardiovascular Health and Health Literacy   Technology Empowered App on Cardiovascular Health and Health Literacy and onsite awareness programme for duration of one year.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Phase I: Young adults studying in health professional colleges between 18-25 years of age
Phase II:
Young adults studying in health professional colleges screened to have suboptimal cardiovascular health during Phase I, having android mobile phones, who are consenting for blood lipids and HbA1c investigation.
 
 
ExclusionCriteria 
Details  Young adults previously diagnosed to have Coronary Artery Disease, Ischemic Heart Disease, Diabetes Mellitus and HbA1c more than 7, Blood pressure level more than 160 and 100, Non HDL more than 220, and on treatment.
on treatment for weight reduction, Polycystic Ovarian Disease
following any dietary regimens or health plans or using any health apps
not available during the data collection period
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
optimal cardiovascular health  at baseline, 3month, 6 month and 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Cardiovascular Health literacy  at baseline, 3month, 6 month and 12 months 
 
Target Sample Size   Total Sample Size="800"
Sample Size from India="800" 
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 2 
Date of First Enrollment (India)   02/12/2024 
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="3"
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 Cluster randomized controlled trial to assess the effectiveness of technology empowered app on Cardiovascular health and health literacy among young adults studying in health professional colleges of Udupi Taluk, Karnataka. The study has 2 phases, Phase 1, cardiovascular health of young adults will be assessed using tool to assess cardiovascular health. The development of technology empowered app will be done in phase 1. Phase 2 those young adults who are screened to have suboptimal cardiovascular health will be assigned to intervention and control group. the control group will receive onsite awareness program, while the intervention group will receive app and onsite awareness programme. Both groups will be followed at baseline, 3 months, 6 months, and 12 months. 
The objectives of the study are 

Phase I

Develop and validate the Technology Empowered App on Cardiovascular Health among young adults of health professional colleges.

Assess the cardiovascular health among the young adults of health professional colleges.

Determine the cardiovascular health literacy among the young adults of health professional colleges.

Phase II 

Find the effectiveness of the App on cardiovascular health and health literacy among the subjects in the experimental group as compared to the control group at baseline, three, six, and twelve months.

 
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