| CTRI Number |
CTRI/2025/03/083277 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
22/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study on Muscle Strength and Function in Obese and Non-Obese Adolescents |
|
Scientific Title of Study
|
A comparative study to assess muscle strength and muscle function of obese and non-obese adolescents in Mumbai |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ansari Alfiya Kausar Salim Ahmed |
| Designation |
student |
| Affiliation |
Dr BMN College of Home Science |
| Address |
Room No 903, D-Wing
Department of Post Graduate Clinical Nutrition and Dietetics
Dr BMN College of Home Science
Kidwai Road Matunga
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9892152846 |
| Fax |
|
| Email |
ansarialfiya2202@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amrita Behel |
| Designation |
Assistant professor |
| Affiliation |
SMT. P.N. DOSHI WOMENS COLLEGE |
| Address |
Department of Food Science and Nutrition
JAG DHIR BODA VIDYA SANKUL,
Camalane, Ghatkopar West,
Mumbai, Maharashtra 400086
Department of Food Science and Nutrition
JAG DHIR BODA VIDYA SANKUL,
Camalane, Ghatkopar West,
Mumbai, Maharashtra 400086
Mumbai (Suburban)
MAHARASHTRA
400086
India |
| Phone |
919869361456 |
| Fax |
|
| Email |
amrita.behel@spndoshi.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amrita Behel |
| Designation |
Assistant professor |
| Affiliation |
SMT. P.N. DOSHI WOMENS COLLEGE |
| Address |
Department of Food Science and Nutrition
JAG DHIR BODA VIDYA SANKUL,
Camalane, Ghatkopar West,
Mumbai, Maharashtra 400086
Department of Food Science and Nutrition
JAG DHIR BODA VIDYA SANKUL,
Camalane, Ghatkopar West,
Mumbai, Maharashtra 400086
Mumbai (Suburban)
MAHARASHTRA
400086
India |
| Phone |
919869361456 |
| Fax |
|
| Email |
amrita.behel@spndoshi.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Alfiya Kausar Salim Ahmed Ansari |
| Address |
plot no.: 25, line number: B, room no.: 08, Govandi, Shivaji Nagar, opposite Jafri School. |
| 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 |
| Mr Feroz |
Al Kausar Urdu High School |
Al Kausar Urdu High School (Primary & Secondary),Govandi, Shivaji Nagar Mumbai 400043, Maharashtra
Mumbai
MAHARASHTRA |
8898904889
noorsabaansari8804@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seva Mandal Education Societys Institutional Ethics Committee (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
A Comparative Study to Assess Muscle Strength and Muscle Function of Obese and Non-Obese Adolescents in Mumbai
|
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
1. Age should be in between (10-17 years)
2. Should be attending Mumbai Schools and colleges
3. Voluntarily agrees to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Any hand or arm injury in the past 6 months
2. Any limitation in the use of both hands that could constrain the proper use of the dynamometer or any other health condition.
3. Refusal to participate in study. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study will throw light on the association between the BMI, dietary and lifestyle choices and muscle strength and muscle function of adolescents in Mumbai. Low levels of physical activity and poor dietary and lifestyle choices may be associated with suboptimal future health of children and adolescents. An understanding of these factors will help make suggestions to bring about improvements for heathier future health outcomes. |
The outcome will be assessed at baseline, 4 weeks, and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association between dietary habits and muscle strength |
At baseline (Through Food Frequency Questionnaire FFQ) |
|
|
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)
|
08/04/2025 |
| 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
|
Title: A Comparative Study to Assess Muscle Strength and Muscle Function of Obese and Non-Obese Adolescents in Mumbai
Brief Summary: This study aims to assess and compare muscle strength and muscle function between obese and non-obese adolescents aged 10-17 years in Mumbai. The study will utilize Body Mass Index (BMI) for obesity classification and employ tools such as the CAMRY Digital Hand Dynamometer to measure handgrip strength and the 6-Minute Walk Test (6MWT) to evaluate muscle function. Dietary habits and physical activity levels will also be assessed to understand their relationship with muscle strength. The findings will contribute to understanding the impact of obesity on muscle performance in adolescents. |