| CTRI Number |
CTRI/2024/05/067895 [Registered on: 27/05/2024] Trial Registered Prospectively |
| Last Modified On: |
22/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Lifestyle factors and their impact on exercise in people with overweight. |
|
Scientific Title of Study
|
Lifestyle factors influencing physical activity among overweight and obese adults. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Maithili Ghule |
| Designation |
postgraduate student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Physiotherapy
Second floor,
Manipal College of Health Professions , Manipal Academy of higher education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9773264161 |
| Fax |
|
| Email |
maithili.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Mukesh K Sinha |
| Designation |
Assistant Professor- Selection Grade |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Physiotherapy, Second floor, Manipal College of Health Professions, Manipal Academy of higher education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9535679047 |
| Fax |
|
| Email |
mukesh.sinha@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mr Mukesh K Sinha |
| Designation |
Assistant Professor- Selection Grade |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Physiotherapy, Second floor, Manipal College of Health Professions, Manipal Academy of higher education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9535679047 |
| Fax |
|
| Email |
mukesh.sinha@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal- 576104 |
|
|
Primary Sponsor
|
| Name |
Maithili Ghule |
| Address |
Department of Physiotherapy, Manipal College of Health Profesions, Manipal Academy of Higher Education, Manipal- 576104 |
| Type of Sponsor |
Other [self] |
|
|
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 Vaishali K |
Kasturba medical college and Kasturba hospital |
Cardiopulmonary fitness laboratory Unit, Department of Physiotherapy, Third floor, CTC block, Kasturba Hospital, Udupi, Manipal
Udupi
KARNATAKA |
9353039762
vaishali.kh@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Overweight and Obese aged between 18-40 years
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
BMI of 25 kg/m2 up to 34.9 kg/m2 |
|
| ExclusionCriteria |
| Details |
1)BMI more than 35 kg/m2 (morbid obese)
2)Individuals diagnosed with cardiovascular, respiratory, neuromotor, musculoskeletal, cognitive disorders
3)Acute or febrile conditions
4)Individuals diagnosed with mental health conditions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VO2MAX, Physical activity, Sedentary behavior, Stress, Sleep, Nutrition, Self efficacy,Motivation,Readiness to change behavior, Social support, Environmental factors, Socioeconomic factors |
One-time baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/06/2024 |
| Date of Study Completion (India) |
31/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
Purpose of the study is to look at the various lifestyle factors, influencing physical activity or exercise for overweight adults. 100 participants including men and women who are overweight, aged 18 to 40 years old with Body Mass Index (BMI) of more than 25 kg/m2 will be enrolled in this study. Participants will be screened for eligibility. Individuals willing to participate will be asked for consent in written. Measurement of their body fat and visceral fat, and checking your physical activity levels. Then, their peak oxygen consumption (VO2 peak) using the submaximal exercise testing (YMCA test). Various lifestyle factors will be measured using questionnaires. |