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CTRI Number  CTRI/2023/03/050615 [Registered on: 13/03/2023] Trial Registered Prospectively
Last Modified On: 09/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Cognitive Retraining]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Cognitive Retraining Intervention for Treating Cognitive Deficits Among Obese Individuals. 
Scientific Title of Study   Efficacy of Cognitive Retraining Based Intervention Module for Treating Cognitive Deficits Among Obese Individuals.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gauri Shanker Kaloiya 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room no: 4085 4th floor AIIMS, New Delhi

South
DELHI
110029
India 
Phone  011-26593705  
Fax    
Email  gkaloiya@aiims.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Gauri Shanker Kaloiya 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room no: 4085 4th floor AIIMS, New Delhi


DELHI
110029
India 
Phone    
Fax    
Email  gkaloiya@aiims.edu  
 
Details of Contact Person
Public Query  
Name  Dr Gauri Shanker Kaloiya 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room no: 4085 4th floor AIIMS, New Delhi


DELHI
110029
India 
Phone    
Fax    
Email  gkaloiya@aiims.edu  
 
Source of Monetary or Material Support  
Department of Medicine, AIIMS, New Delhi 
 
Primary Sponsor  
Name  AIIMS, New Delhi 
Address  AIIMS, NEW DELHI ANSARI NAGAR 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NONE  NONE 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr G S Kaloiya  All India Institute of Medical Sciences  Room no:215 New RAK OPD Department of Medicine
South
DELHI 		 9821805360

gkaloiya@aiims.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee  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  Cogitive retraing based intervention  Participants enrolled in the experimental group will be given standard treatment along with an intervention which involves cognitive retraining as developed in phase 1. This intervention will include 6-8 sessions in the three-month duration, lasting from 45 minutes to one hour.  
Comparator Agent  Standard treatment  Standard care will include dietary counselling, advice to follow moderate-intensity physical activity and pharmacological intervention as per the indication (to be decided by the treating physician). The standard care will be given as per the treatment protocol of the Obesity and metabolic disorder clinic by the faculty and counsellors of the obesity and metabolic disorder clinic. Standard care will be given to participants of both, experimental and control groups.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Body Mass index (more than 25 Kg/m2)
2. Patients with cognitive deficits on Neuropsychological Tests
3. Age 20-50 years
4. Can read and write in Hindi or English
5. Willing to give consent to participate in the study and intend to follow up regularly
 
 
ExclusionCriteria 
Details  1. Pregnancy and lactation at the time of the study (or planning a pregnancy in the next year).
2. Acute infections and advanced end-organ damage.
3. Severe end-organ damage or chronic diseases: renal/ hepatic failure, any malignancy.
4. Any serious medical or psychiatric condition interfering with the intervention.
5. Participants showing possible cognitive decline on MMSE.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
There will be an improvement in the cognitive scores.
The improvement in the psychological scores will be assessed 		 3rd month 
 
Secondary Outcome  
Outcome  TimePoints 
There will be an improvement in psychological measures.
There will be an improvement in blood parameters.
There will be more weight loss in the experimental group in comparison to the control group.
 		 3rd month 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   13/03/2023 
Date of Study Completion (India) 29/01/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 29/01/2024 
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 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This study aimed to determine whether improvements in cognitive function may contribute to higher weight loss in patients presenting overweight/obesity. 
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