CTRI

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CTRI Number

CTRI/2023/08/056683 [Registered on: 21/08/2023] Trial Registered Prospectively

Last Modified On:

19/08/2023

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Cross Sectional Study

Study Design

Single Arm Study

Public Title of Study

Assessment of risk for heart related disease in overweight and obese person.

Scientific Title of Study

Screening for Cardiovascular Disease risk in Overweight and Obese individuals.

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Ramyashree
Designation	PG student
Affiliation	MCHP
Address	2nd Floor Department of Physiotherapy Manipal College of Health Professions Manipal Academy of Higher Education Manipal 576104 2nd Floor, Department of Physiotherapy Manipal College of Health Professions Manipal Academy of Higher Education Manipal 576104 Udupi KARNATAKA 576104 India
Phone	9379625763
Fax
Email	ramyashree.mchpmpl2022@learner.manipal.edu

Details of Contact Person
Scientific Query

Name	Mrs NiveditaS Prabhu
Designation	Assistant professor- selection grade
Affiliation	Manipal College of Health Professions
Address	2nd floor, Department of Physiotherapy Manipal College of Health Professions Manipal Academy of Higher Education Manipal 576104 Udupi KARNATAKA 576104 India
Phone	9901729546
Fax
Email	nivedita.kamath@manipal.edu

Details of Contact Person
Public Query

Name	Dr G Arun Maiya
Designation	Dean, Manipal College of Health Professions
Affiliation	Manipal College of Health Professions
Address	2nd floor, Department of Physiotherapy Manipal College of Health Professions Manipal Academy pf Higher Education Manipal 576104 Udupi KARNATAKA 576104 India
Phone	9845350823
Fax
Email	arun.maiya@manipal.edu

Source of Monetary or Material Support

Kasturba Hospital, Manipal, Udupi, Karnataka

Primary Sponsor

Name	Ramyashree
Address	Department of Physiotherapy, Manipal College Of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka, India
Type of Sponsor	Research institution and hospital

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
Ramyashree	Kasturba Hospital	Fitness lab, Department of Physiotherapy, Baliga block, Kasturba Hospital Udupi KARNATAKA	9379625763 ramyashree.mchpmpl2022@learner.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 - 2 (Student Research)	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Healthy individual who comes under overweight and obese category

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	NIL	NIL

Inclusion Criteria

Age From	18.00 Year(s)
Age To	45.00 Year(s)
Gender	Both
Details	Individual with age of 18yrs - 45yrs Waist circumference: (For men:>85, For women:>80cm) Waist to hip ratio: (For men:>0.88, For women:>0.81)

ExclusionCriteria

Details

Individuals under any medications for any cardiovascular related co-morbidities.
History of renal or hepatic diseases
Chronic smokers and alcoholics(>6months)

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Screening for cardiovascular disease risk in overweight & obese individuals	1 year

Secondary Outcome

Outcome	TimePoints
Profiling of Physical activity	1year

Target Sample Size

Total Sample Size="244"
Sample Size from India="244"
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)

28/08/2023

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="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

Permission to conduct the study is obtained from Institutional Research Committee(IRC), MCHP, MAHE, and Institutional Ethics Committee (IEC), Kasturba Hospital, Manipal. After obtaining approval, the study will be registered under the Clinical Trials Registry India (CTRI).

The Will be a cross sectional observational study including 244 participants.

All participants who are visiting the Department of Medicine and the general population who are Overweight and obese individual will be screened thoroughly for inclusion and exclusion criteria. Study protocol will be explained to the participant and participant information sheet will be given following which Informed consent will be taken. they will be screened routinely for Body Composition Analysis using Bioelectrical Impedance analyzer (BIA) and routine blood reports as prescribed by the physician will be recorded from the clinical records based on the Inclusion and exclusion criteria. Demographic data will be taken. Body weight and Height will be measured relatively using a stadiometer and weighing machine. Waist and hip circumference will be measured using inch tape. Global Physical Activity Questionnaire (GPAQ) will be administered to all participants and the investigator will help them to fill it. The collected data will be analyzed. The participants will be categorized according to their level of physical activity with the help of score obtained from GPAQ.