| CTRI Number |
CTRI/2024/10/075902 [Registered on: 25/10/2024] Trial Registered Prospectively |
| Last Modified On: |
23/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
How childhood obesity affects behavior and mental health of a child |
|
Scientific Title of Study
|
Impact of Childhood Obesity on Mental Health, Behavioral Challenges, and Quality of Life: A Cross-Sectional Survey |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Riya sharma |
| Designation |
student |
| Affiliation |
Galgotias university |
| Address |
School of Allied Health Sciences, Department of Physiotherapy, B-315, Galgotias university Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9258790220 |
| Fax |
|
| Email |
riyyaa1101@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Alay Raj |
| Designation |
Student |
| Affiliation |
Galgotias university |
| Address |
School of Medical and Allied Health Sciences, Department of Physiotherapy, Galgotias University Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
7488723980 |
| Fax |
|
| Email |
Alayrathore567@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rituraj verma |
| Designation |
Professor |
| Affiliation |
Galgotias university |
| Address |
School of Medical and Allied Health Sciences, Department of Physiotherapy, Galgotias University Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9953434095 |
| Fax |
|
| Email |
rituraj.verma@galgotiasuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of physiotherapy galgotias university Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201 |
|
|
Primary Sponsor
|
| Name |
Galgotias university |
| Address |
School of Medical and Allied Health Sciences, Department of Physiotherapy, Galgotias University Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida |
| Type of Sponsor |
Research institution |
|
|
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 Rituraj verma |
Galgotias university |
School of Medical and Allied Health Sciences, Department of Physiotherapy, Galgotias University Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH |
9953434095
rituraj.verma@galgotiasuniversity.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Research Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z685||Body mass index (BMI) pediatric, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 6 to 14 years.
Children diagnosed with obesity BMI 25-34.9(10).
Non-obese children BMI 18.5-24.9(10).
Consent from parents/guardians and assent from the children. |
|
| ExclusionCriteria |
| Details |
Children with chronic medical conditions affecting weight or growth (e.g., endocrine disorders).
Children with diagnosed psychological or developmental disorders unrelated to obesity.
Lack of consent from parents/guardians.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Level of anxiety
Depression
self esteem |
One time study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Behavioral challenges
Social challenges
Quality of Life |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
19/11/2024 |
| 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="0"
Months="2"
Days="2" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Childhood obesity is a rapidly escalating public health concern globally, with significant implications for both physical and mental well-being. The prevalence of childhood obesity has more than doubled in the past three decades, affecting millions of children worldwide. According to the World Health Organization (WHO), over 340 million children and adolescents aged 5-19 were classified as overweight or obese in 2016, a trend that shows no signs of abating. While the physical health consequences of childhood obesity, such as type 2 diabetes, cardiovascular disease, and orthopedic complications, have been extensively studied, its impact on mental health remains relatively underexplored. This observational study aims to address this gap by examining the complex relationship between child obesity and mental health, highlighting the psychological challenges faced by obese children and the broader social, environmental, and behavioral factors that contribute to this multifaceted issue. |