| 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
|
|
|
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
|
|
|
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. |