| CTRI Number |
CTRI/2023/12/060421 [Registered on: 01/12/2023] Trial Registered Prospectively |
| Last Modified On: |
27/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Activity levels (walking, jogging, etc.) and the sleeping time in individuals and how they might be related to any diseases risk (blood pressure, diabetes, etc.) in individuals living in Udupi taluk. |
|
Scientific Title of Study
|
Physical activity levels and sleep time and its relation to chronic disease risk in Indian adults living in Udupi taluk: a cross sectional study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manaswi Reddy Aerva |
| Designation |
Post graduate student |
| Affiliation |
Manipal academy of higher education (MAHE) |
| Address |
2nd floor, Department of Exercise and Sports Science, Manipal college of health professions, MAHE.
Udupi
KARNATAKA
576104
India |
| Phone |
9618747478 |
| Fax |
|
| Email |
manaswi.mchpmpl2022@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Manaswi Reddy Aerva |
| Designation |
Post graduate student |
| Affiliation |
Manipal academy of higher education |
| Address |
2nd floor, Department of exercise and sports science, Manipal college of health professions, MAHE.
Udupi
KARNATAKA
576104
India |
| Phone |
9618747478 |
| Fax |
|
| Email |
manaswi.mchpmpl2022@learner.manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Baskaran Chandrasekaran |
| Designation |
Assistant professor |
| Affiliation |
Manipal college of health professions |
| Address |
2nd floor, Exercise and Sport Science Department, Manipal college of health professions (MCHP), MAHE.
Udupi
KARNATAKA
576104
India |
| Phone |
7639280758 |
| Fax |
|
| Email |
baskaran.c@manipal.edu |
|
|
Source of Monetary or Material Support
|
| 2nd floor, Department of exercise and sports science, Manipal College of Health Professions, MAHE. |
|
|
Primary Sponsor
|
| Name |
Manipal College of Health Professions |
| Address |
Department of Exercise and sport science, Manipal college of health professions, MAHE |
| Type of Sponsor |
Private medical college |
|
|
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 Baskaran Chandrasekaran |
Manipal College of Health Professions |
9Q4M+HX2, 2nd floor, Department of exercise and sport science, Manipal college of health professions, MAHE.
Udupi
KARNATAKA |
7639280751
baskaran.c@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
general community dwelling adults |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
People living in Udupi taluk.
People who understand, read and write Kannada.
People who understand, read and write English. |
|
| ExclusionCriteria |
| Details |
People who do not have internet access |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| physical activity levels and sleep time |
one time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| non communicable diseases. |
one time |
|
|
Target Sample Size
|
Total Sample Size="265"
Sample Size from India="265"
Final Enrollment numbers achieved (Total)= "310"
Final Enrollment numbers achieved (India)="310" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/12/2023 |
| Date of Study Completion (India) |
23/02/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
This is a cross sectional study to explain the potential association of physical activity levels and sleep time with chronic diseases risk. The population of interest is from Udupi Taluk. The questionnaire will be advertised on social media and on University campus in Udupi where they can access and answer the questionnaire. The responses on physical activity and sleep time will be calculated using frequency models. The relation between physical activity, sleep time and chronic diseases risk will be calculated using linear models. |