| CTRI Number |
CTRI/2023/07/054988 [Registered on: 10/07/2023] Trial Registered Prospectively |
| Last Modified On: |
09/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessing the Diet pattern, Physical Activity Levels and Muscular and Skeletal Health of Corporate Executives in Mumbai |
|
Scientific Title of Study
|
Assessment of Dietary pattern, Physical Activity Levels and Musculoskeletal Health of Corporate Executives in Suburban Mumbai |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Radhika Mishra |
| Designation |
Student- M.Sc. in Clinical Nutrition and Dietetics |
| Affiliation |
Dr. BMN College of Home Science |
| Address |
Dr. BMN College of Home Science, Department of Postgraduate Studies in Clinical Nutrition and Dietetics, 338, R.A. Kidwai Road, Matunga, Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400019
India |
| Phone |
|
| Fax |
|
| Email |
radhikamishra112233@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rupali Sengupta |
| Designation |
Head of the Department |
| Affiliation |
Dr. BMN College of Home Science |
| Address |
Dr. BMN College of Home Science, Department of Postgraduate Studies in Clinical Nutrition and Dietetics, 338, R.A. Kidwai Road, Matunga, Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400019
India |
| Phone |
|
| Fax |
|
| Email |
rupali@bmncollege.com |
|
Details of Contact Person
Public Query
|
| Name |
Radhika Mishra |
| Designation |
Student- M.Sc. in Clinical Nutrition and Dietetics |
| Affiliation |
Dr. BMN College of Home Science |
| Address |
Dr. BMN College of Home Science, Department of Postgraduate Studies in Clinical Nutrition and Dietetics, 338, R.A. Kidwai Road, Matunga, Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400019
India |
| Phone |
|
| Fax |
|
| Email |
radhikamishra112233@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Radhika Mishra |
| Address |
338, R.A. Kidwai Road, Matunga, Mumbai, Maharashtra 400019 |
| Type of Sponsor |
Other [Self Sponsored] |
|
|
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 |
| Radhika Mishra |
Dr. BMN College of Home Science |
Dr. BMN College of Home Science, Department of Postgraduate Studies in Clinical Nutrition and Dietetics, 338, R.A. Kidwai Road, Matunga, Mumbai, Maharashtra
Mumbai
MAHARASHTRA |
8668725639
radhikamishra112233@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seva Mandal Education Societys Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NA |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Corporate executives
Working at least 7 hrs./day
Executives who are willing to participate
Working in Suburban Mumbai |
|
| ExclusionCriteria |
| Details |
Anyone not willing to participate
Anyone with a history of trauma, spinal fracture/ surgery, degenerative, inflammatory musculoskeletal conditions like osteoarthritis, spondylitis, rheumatoid arthritis, kidney conditions, etc. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Corporate executives may have an unhealthy dietary pattern and low physical activity levels.
Unhealthy diet, sedentary lifestyle may have an effect on musculoskeletal health of corporate executives. |
At baseline |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
19/07/2023 |
| 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="0"
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
|
Aim: To study the correlation between Dietary pattern, Physical activity levels and Musculoskeletal health in Corporate executives in Suburban Mumbai.
Objectives:
- To assess the dietary pattern of corporate executives using FFQ - To asses the physical activity levels of corporate executives using GPAQ - To assess the Musculoskeletal health of Corporate executives using Nordic Musculoskeletal Questionnaire. - To compare all the parameters under the study and its effect on corporate executives.
|