| 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
|
|
|
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
|
|
|
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.
|