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CTRI Number  CTRI/2023/09/057842 [Registered on: 19/09/2023] Trial Registered Prospectively
Last Modified On: 17/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role of Cognitive Behavioral therapy in treatment of overweight and obese children in India 
Scientific Title of Study   Effect of Targeted Cognitive Behavioral Therapy on physical and psychological well-being in children with obesity and overweight: A Hospital-Based Randomized Control Trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tulasiram Nallam 
Designation  Junior Resident 
Affiliation  AIIMS PATNA 
Address  Department of Paediatrics, D2B, 2nd Floor, AIIMS Patna, Patna - Aurangabad Rd, Phulwari Sharif, Patna, Bihar 801507

Patna
BIHAR
801507
India 
Phone  9966050828  
Fax    
Email  mailmethulasiram@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrPradeep Kumar 
Designation  Associate Professor 
Affiliation  AIIMS PATNA 
Address  Department of Paediatrics, D2B, 2nd Floor, AIIMS Patna, Patna - Aurangabad Rd, Phulwari Sharif, Patna, Bihar 801507Bihar 801507

Patna
BIHAR
801507
India 
Phone  9939980752  
Fax    
Email  drpradeepkumar@aiimspatna.org  
 
Details of Contact Person
Public Query  
Name  Tulasiram Nallam 
Designation  Junior Resident 
Affiliation  AIIMS PATNA 
Address  Department of Paediatrics, D2B, 2nd Floor, AIIMS Patna, Patna - Aurangabad Rd, Phulwari Sharif, Patna, Bihar 801507

Patna
BIHAR
801507
India 
Phone  9966050828  
Fax    
Email  mailmethulasiram@gmail.com  
 
Source of Monetary or Material Support  
Department of pediatrics,ALL INDIA INSTITUTE OF MEDICAL SCIENCES,PHULWARISHERIFF PATNA,BIHAR,801507 
 
Primary Sponsor  
Name  AIIMS PATNA 
Address  AIIMS Patna- Aurangabad Rd, Phulwari Sharif, Patna, Bihar 801507 
Type of Sponsor  Government medical college 
 
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 
DrTULASI RAM NALLAM  AIIMS PATNA  Paediatrics Medicine OPD and IPD 2nd Floor, AIIMS Patna - Aurangabad Rd, Phulwari Sharif, Patna, Bihar 801507 Patna BIHAR
Patna
BIHAR 		 9966050828

mailmethulasiram@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,ALL INIDIA INSTITUTE OF MEDICAL SCIENCES,PATNA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E660||Obesity due to excess calories,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  COGNITIVE BEHAVIORAL THERAPY  COGNITIVE BEHAVIORAL THERAPY includes both Psychoeducation,and modification eating habits, physical activity, recognition and restructuring of negative thoughts, stress management, improving problem solving skills and maintenance and relapse prevention etc.The total duration of intervention is for a period of 6 months with therapy sessions divided as fortnightly for 3 months and once a month for 2 months with total sessions of 8.Assesment is done at 3 months,6 months and 9 months of start of the trial seperately for each individual. 
Comparator Agent  Standard therapy (pharmacological and physical exercise )  use of Regular physical exercise and medication like metformin.The assesment will be done at 3,6 and 9 months of beginning of trial seperately for each individual. 
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  Children aged between 7-16 years who are overweight or obese as per Indian academy of Paediatrics criteria (IAP BMI charts 2015)  
 
ExclusionCriteria 
Details  1. Patients receiving medication known to cause weight gain (corticosteroids, antipsychotics, antiepileptics etc.)
2. Syndromic overweight and obese patients
3. Developmentally delayed patients
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction of weight, along with improved psychological wellbeing of the patients  3 time points - 3 months,6 months and 1 year of initiation therapy  
 
Secondary Outcome  
Outcome  TimePoints 
- To determine the effect of Cognitive Behavioral Therapy with Standard Therapy on complications of overweight and obesity in children  3 time points - 3 months,6 months and 1 year of initiation therapy  
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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)   29/09/2023 
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 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  

This trial objective is to assess the effectiveness of Cognitive Behavioral Therapy (CBT) on overweight and obese children. Obesity is a growing concern among both adult and paediatric population across the globe. It’s prevalence has increased in the last decade mainly among paediatric population. Standard management of obesity includes diet modification and physical exercise along with drugs such as metformin but Obese children are more prone for psychiatric issues like depression, anxiety, attention deficit hyperactivity disorder, eating disorders etc and also for psychosocial issues like decreased self-esteem, bullying etc, thus affecting both psychological and social wellbeing of children. Therefore, CBT which helps in management of obesity and its associated complications is being under trial worldwide.

The study’s primary objective is to To identify the changes in body mass index, waist circumference, wrist circumference, waist to height ratio and psychological aspects in overweight and obese children aged 7-16 years treated with Cognitive Behavioral Therapy along with Standard Therapy.

The research question focuses on this comparison, and two hypotheses have been formulated accordingly: the null hypothesis states that CBT has no role in management of overweight and obesity, while the alternate hypothesis suggests that CBT has role in management of overweight and obesity along with standard therapy

 The study will be a single-centre, open-label, randomized controlled trial, involving Children aged between 7-16 years who are overweight or obese as per Indian academy of Paediatrics criteria (IAP BMI charts 2015) . Participants will be assigned randomly to one of two groups: the first group will receive CBT along with standard therapy, while the second group will receive standard therapy alone. The study will assess the impact of investigate the effect of cognitive-behavioral therapy along with standard therapy in treating overweight and obese children. Therapy response will  be evaluated at different time points

 The potential benefits of this study are substantial. Simple CBT changes in management of obesity might lead to a significant improvement in  both physical and psychological health of children. This could lead to improved management of obesity and obesity related complications.

 

 
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