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CTRI Number  CTRI/2025/01/079723 [Registered on: 29/01/2025] Trial Registered Prospectively
Last Modified On: 28/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   correlation between sleep time, screen time and playtime on anthropometry in school children 
Scientific Title of Study   Correlation between quality of physical activity, sleep pattern and screen time on anthropometry in school going children between the age 6-12 years in post covid era - cross sectional study 
Trial Acronym  Correlation between activities and anthropometry  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sanjana M 
Designation  MBBS Post graduate in Paediatrics 
Affiliation  BGS Global Institute of Medical Sciences  
Address  Department of Paediatrics BGS Global Institute of Medical Sciences Kengeri Bangalore Karnataka 560060
Kengeri Bengaluru 560060
Bangalore
KARNATAKA
560060
India 
Phone  9945885938  
Fax    
Email  sanjanamanjunath.95@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr RAMESH M 
Designation  PROFESSOR and Head of the department of Paediatrics  
Affiliation  BGS Global Institute of Medical Sciences  
Address  Department of Paediatrics BGS Global Institute of Medical Sciences Kengeri Bangalore Karnataka 560060
Kengeri Bengaluru 560060
Bangalore
KARNATAKA
560060
India 
Phone  9900111261  
Fax    
Email  rameshmalliah@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ramesh M 
Designation  PROFESSOR AND HEAD OF THE DEPARTMENT of Paediatrics  
Affiliation  BGS Global Institute of Medical Sciences  
Address  DEPTMENT OF PAEDIATRICS BGS Global Institute of Medical Sciences Kengeri BENGALURU 560060
KENGERI BENGALURU 560060
Bangalore
KARNATAKA
560060
India 
Phone  9900111261  
Fax    
Email  rameshmalliah@gmail.com  
 
Source of Monetary or Material Support  
BGS Global Institute of Medical Sciences Kengeri Bangalore Karnataka India 570060 
 
Primary Sponsor  
Name  Dr Sanjana M 
Address  BGS Global Institute of Medical Sciences Kengeri Bangalore India 560060 
Type of Sponsor  Other [SELF] 
 
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 SANJANA M  BGS   BGS Public school KENGERI BENAGLURU Karnataka 560060
Bangalore
KARNATAKA 
9945885938

sanjanamanjunath.95@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
BGS GIMS IEC  Approved 
BGS GIMS institutional ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  STABLE 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  ALL SCHOOL GOING CHILDREN BETWEEN THE AGE 6 TO 12 YEARS OF AGE
All children whose parents fill the forms and give approval  
 
ExclusionCriteria 
Details  CHILDREN WITH KNOWN CHRONIC MEDICAL ILLNESSES LIKE RENAL FAILURE, CONGENITAL HEART DISEASES, CONGENITAL MALFORMATIONS, CHILDREN WITH DISABILITY AND SYNDROMIC CHILDREN.
PARENTS OF CHILDREN WHO DID NOT GIVE CONSENT. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
to estimate height weight and BMI among school children between the age 6 to 12 years  6 months  
 
Secondary Outcome  
Outcome  TimePoints 
to estimate the physical activity score Pittsburgh sleep quality index & digital screen exposure in children between the age 6 to 12 years  6 months 
to correlate the impact of digital screen time duration & quality of physical activity sleep pattern & Childs anthropometry   6 months 
 
Target Sample Size   Total Sample Size="460"
Sample Size from India="460" 
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)   10/02/2025 
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="1"
Months="1"
Days="1" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

SARS COV-2 VIRUS was first identified in the city of Wuhan, China in 2019. And the WHO declared the outbreak as public health emergency of international concern, and a pandemic on March 11, 2020. First case was detected in India on- January 27, 20202.

India has already had 3 waves; among them the first two waves had a very bad impact on the entire population. During the coronavirus disease 2019 (COVID-19) pandemic, social distancing policies such as home confinement, school closures, and minimal/no outdoor play for all children, resulted in unusual lifestyle changes in children and adolescents and lead to increased usage of gadgets and screen time. Studies have shown that the lockdown measures have affected the general well-being of children and adolescents more profoundly than the infection itself. Due to lockdown, schools were shut and classes were conducted online. Previously there were recommendations for screen time based on the age of child, which were being followed sparingly. Due to online teaching all the children were exposed to gadgets and were forced to outway from the recommendation.  Because of lockdown the kids were confined to home and physical activities significantly reduced. Since the outbreak, there has been increasing interest in the impact of these policies on physical activity (PA), screen time, and sleep patterns among children and adolescents. The prevalence of physically inactive school-aged children increased from 21% in January 2020 to 66% in March 2020 

Sleep especially, night sleep has a very important role to play in the circadian rhythm and general well being of child. Hormones such as growth hormone, melatonin and adrenocorticotropic hormone (GH and ACTH) have diurnal regulation and is related to sleep. Studies have shown potential influence of the COVID 19 pandemic on sleep quality in children and adolescents. Children also had a longer sleep duration, with delayed sleep onset and wake-up times, as a result of homeschooling, increased screen time and lack of physical activity. Although adequate sleep is mandatory for children, researchers found a pooled prevalence of sleep disturbances of up to 54% in children during the pandemic.

A recent report in the US showed that the non-academic screen time of children doubled during the COVID-19 pandemic from 3.8 to 7.7 h a day. This raises concerns regarding the known potential harms of excessive screen time, mainly the risks to health physical and mental health such as greater obesity and higher depressive symptoms, among school-aged children. 

The COVID-19 pandemic could have exacerbated existing lifestyle problems such as physical inactivity and sedentary lifestyles due to missed Physical activity classes which used to be mandatory before in school, because of lockdown the peer to peer group interaction/ play were affected and contributed to the increased screen time.

Studies have shown, onset of chronic health conditions like obesity, hypertension, diabetes mellitus, etc are due to lifestyle modifications in early age. 

I would like to conduct a study to know the correlation between lifestyle habits, including physical activity, sleep patterns, and screen time and  anthropometry, post COVID-19 outbreak and in order to examine the impact of it on children. 


 
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