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CTRI Number  CTRI/2023/11/059851 [Registered on: 15/11/2023] Trial Registered Prospectively
Last Modified On: 14/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   CORRELATIONAL STUDY 
Study Design  Single Arm Study 
Public Title of Study   The Association Between Obesity and Mental Processes Like Thinking, Learning and Academic Performance Among Adolescents Enrolled in School 
Scientific Title of Study   Correlation of Obesity with Cognition, Metacognition and Academic Performance in School Going Adolescents 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nandini Narang 
Designation  PG Student 
Affiliation  Amar Jyoti Institute of Physiotherapy, University of Delhi, Karkardooma, Delhi 
Address  Amar Jyoti Institute of Physiotherapy, University of Delhi, Karkardooma, Delhi

East
DELHI
110092
India 
Phone  9654690538  
Fax    
Email  nandini2697@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nidhi Singh 
Designation  Assistant Professor, Amar Jyoti Institute of Physiotherapy 
Affiliation  Amar Jyoti Institute of Physiotherapy, University of Delhi, Karkardooma, Delhi 
Address  Amar Jyoti Institute of Physiotherapy, University of Delhi, Karkardooma, Delhi

East
DELHI
110092
India 
Phone  7042627025  
Fax    
Email  nidhi.singh2411@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Nandini Narang 
Designation  PG Student 
Affiliation  Amar Jyoti Institute of Physiotherapy, University of Delhi, Karkardooma, Delhi 
Address  Amar Jyoti Institute of Physiotherapy, University of Delhi, Karkardooma, Delhi

East
DELHI
110092
India 
Phone  9654690538  
Fax    
Email  nandini2697@gmail.com  
 
Source of Monetary or Material Support  
Amar Jyoti Institute of Physiotherapy, University of Delhi, Karkardooma, Delhi 
 
Primary Sponsor  
Name  Nandini Narang 
Address  Amar Jyoti Institute of Physiotherapy, University of Delhi, Karkardooma, Delhi-110092 
Type of Sponsor  Other [Self Funded] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nidhi Singh   Inspirations Eduservices  144, Pocket 16, Sector 24, Rohini, Delhi 110085
North West
DELHI 
7042627025

nidhi.singh2411@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Amar Jyoti Institutional Review Board- Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Adolescents with BMI more than 30  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  17.00 Year(s)
Gender  Both 
Details  1. Healthy adolescents
2. School going adolescents of age 13-17 years with BMI more than 30
3. Ability to read, speak and understand English
4. Both genders
 
 
ExclusionCriteria 
Details  1. Students with known cases of chronic diseases such as diabetes mellitus, asthma, epilepsy, cognitive disorders, vision problems, anxiety, skeletal muscle disorders
2. Students who had a history of sleep disturbance or were using sedatives
3. Students with history of any psychiatric illness like ADHD, schizophrenia, bipolar disorder
4. Students with color blindness
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Body Mass Index, Stroop Color And Word Test And Metacognition Awareness Inventory  At baseline  
 
Secondary Outcome  
Outcome  TimePoints 
ACADEMIC PERFORMANCE SCORE  ONE TIME 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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)   01/12/2023 
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="1"
Months="0"
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  

The present study is observational (correlational study). The title of the study is ‘Correlation of Obesity with Cognition, Metacognition and Academic Performance in School Going Adolescents’. The purpose of the study is to find out if obesity is correlated with cognition, metacognition and academic performance in school going adolescents in south east Asian population. There is a relative dearth of research specifically focusing on cognition and metacognition in relation to obesity in adolescents. More research is needed to explore how obesity may specifically affect metacognitive abilities and the potential implications for academic performance and self-regulated learning. The procedure involves selection of adolescents aged 13-17 years meeting inclusion criterion of BMI> 30. The sampling method is convenience sampling. The cognition of subjects is assessed by Stroop Word and Color test. The subject’s task is to look at each sheet and move down the columns, reading words or naming the ink color as quickly as possible, within given time limit (45 seconds). Three scores, as well as an interference score are generated using the number of items completed on page, with higher scores reflecting better performance and less interference on reading ability.  The metacognition is checked by Metacognition awareness inventory where students will fill the questionnaire. Academic performance record is collected as average percentage of last 2 Examination with teacher assistance. Data will be recorded and analyzed.

 
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