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CTRI Number  CTRI/2022/07/044364 [Registered on: 27/07/2022] Trial Registered Prospectively
Last Modified On: 23/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Rise in the trend of Obesity Among Children in the Post Covid 19 pandemic Lockdown period in Dharwad City 
Scientific Title of Study   Shift in the Prevalence of Obesity Among Primary School Going Children Post Covid 19 pandemic Lockdown in Dharwad City 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nidhi Satish Mehta  
Designation  Post Graduate Student  
Affiliation  SDM College of Physiotherapy 
Address  SDM College of Medical Sciences and Hospital SDM College of Physiotherapy Manjushree Nagar Sattur Dharwad

Dharwad
KARNATAKA
580009
India 
Phone  9742863190  
Fax  08362462253  
Email  nidhi16mehta@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jyoti S Jeevannavar 
Designation  Professor and PG Guide 
Affiliation  SDM College of Physiotherapy 
Address  SDM College of Medical Sciences and Hospital SDM College of Physiotherapy Manjushree Nagar Sattur Dharwad

Dharwad
KARNATAKA
580009
India 
Phone  9972189767  
Fax  08362462253  
Email  drjyotisj@gmail.com  
 
Details of Contact Person
Public Query  
Name  Nidhi S Mehta  
Designation  Post Graduate Student 
Affiliation  SDM College of Physiotherapy 
Address  SDM College of Medical Sciences and Hospital SDM College of Physiotherapy Manjushree Nagar Sattur Dharwad

Dharwad
KARNATAKA
580009
India 
Phone  9742863190  
Fax  08362462253  
Email  nidhi16mehta@gmail.com  
 
Source of Monetary or Material Support  
SDM College of Physiotherapy Manjushree Nagar Sattur Dharwad 
 
Primary Sponsor  
Name  Nidhi Satish Mehta  
Address  SDM College of Medical Sciences and Hospital SDM College of Physiotherapy Manjushree Nagar Sattur Dharwad 
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 
Nidhi Satish Mehta  SDM College of Medical Sciences and Hospital   Paediatric Physiotherapy Department OPD No.13 SDM College of Medical Sciences and Hospital SDM College of Physiotherapy Manjushree Nagar Sattur Dharwad
Dharwad
KARNATAKA 		 9742863190
08362462253
nidhi16mehta@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Permission   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy primary school going children  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1.Typically developing primary school going children.
2.Children of either gender.
3.Parents of children who consent for their child’s participation in the study.
 
 
ExclusionCriteria 
Details  1.Children who were diagnosed COVID-19 positive during the lockdown.
2.Children who don’t give assent for participation.
3.Children with history of developmental delay or diagnosed with other medical condition.
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Self Generated Questionnaire For Childs Physical Activity Levels and BMI.  One Time Assessment 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="300" 
Phase of Trial   N/A 
Date of First Enrollment (India)   27/07/2022 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   none at present 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

OBESITY is defined as abnormal or excessive fat accumulation that may impair health. Paediatric or childhood obesity is a growing global epidemic that requires attention due to the burden placed on the health care system for children and adults.

Childhood obesity has turned out as a major public health issue of the 21st century with an alarming rise in its prevalence in several developing countries. Paediatric or childhood obesity is the most prevalent nutritional disorder among children and adolescents worldwide. In past 30 years, paediatric obesity has more than doubled in children and tripled in adolescents worldwide. Individuals with an 85-95% BMI are classified as overweight and those with 95% BMI are classified as obese.

Childhood obesity is now an epidemic in India. With 14.4 million obese children, India has the second-highest number of obese children in the world, next to China. The prevalence of overweight and obesity in children is 15%. In private schools catering to upper-income families, the incidence has shot up to 35-40%, indicating a worrying upward trend. 

Childhood obesity is a serious medical condition that affects children and adolescents. It is particularly troubling because the extra pounds often start children on the path to health problems that were once considered as adult problems. Paediatric obesity affects all the organs in the body and has an increasing prevalence in young diabetic children. Childhood obesity is connected with increased risk of various diseases such as diabetes, cardiovascular, stroke, certain types of cancer later in life, social problem and depression among youth.   

Obesity occurs when the body consumes more calories than it burns, through overeating and under exercising. Childhood obesity is caused by excessive food consumption and drinking of high-calorie sweetened beverages, fatty foods, no exercise or physical activity, as well as genetic factors.

The fundamental cause of childhood obesity is an imbalance between calories consumed and energy spent. Indians are genetically predisposed to obesity. However, the rapid increase in childhood obesity is largely due to environmental influences. Economic prosperity leads to a change in diet from traditional to ‘modern’ foods, rich in fat and sugar. Urbanization leads to an increase in sedentary lifestyles and a decline in physical activity.

During the Covid 19 pandemic the central, state and local governments in India, put in place numerous restrictions on human movement and physical interactions in order to prevent the spread of COVID-19. Starting mid-March 2020, primary and secondary schools were closed. Children no longer had access to school based physical activities such as physical education, recess, and walking to/from school. It has been argued COVID-19 school closures may lead to increased rates of obesity in children in part because schools provide opportunities and facilities for physical activity through physical education and recess. Further the social-distancing measures which were necessary to slow the spread of COVID-19, limited the children’s ability to engage in sufficient levels of physical activity (PA) to maintain health and prevent disease.   

Children were typically engaged in lower levels of physical activities and had more sedentary time on weekend days as compared to school days. It is also known that Children tend to gain more weight over the summer, especially those who are not enrolled in structured summer camps and any physical activities. Insufficient Physical Activities and excessive sedentary behaviour (SB) among children represents a significant problem because health behaviour patterns in childhood are likely to persist into adulthood and can lead to increased risk for a number of serious health conditions (e.g., over weight/obesity, type II diabetes, and metabolic syndrome) in later childhood and adulthood.  

During COVID 19 lockdown children may not have had sufficient opportunities to take part in any physical activities and going out. This along with improper diet may lead to obesity/overweight in children. Hence this study would like to identify the shift in the prevalence of obesity as an effect of COVID LOCKDOWN among children.
 
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