| CTRI Number |
CTRI/2024/04/065302 [Registered on: 05/04/2024] Trial Registered Prospectively |
| Last Modified On: |
04/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Association of total body fat and belly fat in middle aged women of West India |
|
Scientific Title of Study
|
Association of general obesity and visceral obesity in middle aged women of West India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rinkal Chavda |
| Designation |
Resident doctor |
| Affiliation |
Government Medical College Bhavnagar |
| Address |
Resident room, Department of Physiology, Government Medical College Bhavnagar, Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9408116858 |
| Fax |
|
| Email |
rinkalchavda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayesh Solanki |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College Bhavnagar |
| Address |
Department of Physiology, Government Medical College Bhavnagar, Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9898361004 |
| Fax |
|
| Email |
drjaymin_83@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rinkal Chavda |
| Designation |
Resident Doctor |
| Affiliation |
Government Medical College Bhavnagar |
| Address |
Resident room, Department of Physiology, Government Medical College Bhavnagar, Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9408116858 |
| Fax |
|
| Email |
rinkalchavda@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College Bhavnagar, India -364001 |
|
|
Primary Sponsor
|
| Name |
Government Medical College Bhavnagar |
| Address |
Government Medical College Bhavnagar, behind S T bus stand, jail road, Bhavnagar,India-364001 |
| Type of Sponsor |
Government 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 Rinkal Chavda |
Government Medical College Bhavnagar |
Department of Physiology, Government Medical College, behind S T bus stand, jail road, Bhavnagar-364001
Bhavnagar
GUJARAT |
9408116858
rinkalchavda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee, Government Medical College Bhavnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Apparently healthy females of age 40-60 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Apparently healthy females of age 40 to 60 years |
|
| ExclusionCriteria |
| Details |
1)Subject with known chronic disease
2)Dehydration during BEI analysis
3)Individual with thyroid disorder (self-reported)
4)Individual consuming alcohol, tobacco or smoking (self-reported) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study will show prevalence of general and visceral obesity and their association with each other in middle aged women from our city. |
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
This study will give association of both obesity in middle aged women With menopause & SRPA (self reported physical activity)
|
At baseline |
|
|
Target Sample Size
|
Total Sample Size="196"
Sample Size from India="196"
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)
|
01/05/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Study design: A cross-sectional study Study population : General population . Study Duration: 6 months (4+2) Duration of Data collection : 4 months Sample size: 196 (Raosoft sample size calculator) Confidence level 95% Margin of error 5% Response percentage 5% Population: 10 Lakhs Sampling method: convenient sampling
JUSTIFICATION: Obesity is lifestyle related disorder. In Middle aged women due to estrogen Support withdrawal, there is adverse body composition change, leading to obesity. In light of this , we intend to study prevalence of general and visceral obesity and their association with each other in middle aged women from our city. This study will give prevalence & association of both obesity in middle aged women.
OBJECTIVES: (1) To estimate WC, HC & WHR of Study participants (2) To assess body composition by bio-electrical impedance of study participants(3) To determine proportion of participants having general or visceral obesity. (4) To compare visceral Obesity in groups stratified by general Obesity. (5) To compare general & Visceral Obesity among groups stratified by menopause and physical activity (self-reported)(SRPA)
|