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CTRI Number  CTRI/2021/07/035285 [Registered on: 30/07/2021] Trial Registered Prospectively
Last Modified On: 29/07/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Other 
Public Title of Study   Effect of giving reminder calls for appointment to Severely Acute Malnourished children receiving treatment. 
Scientific Title of Study   A single blinded, randomized control trial on improving adherence to treatment of Severe acute malnutrition by providing reminder calls. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Alka Jadhav  
Designation  Professor Pediatrics  
Affiliation  Lokmanya Tilak Municipal Medical College and General Hospital  
Address  Room no. 120, 1st floor, college building, LTMGH and LTMMC, Dr. Babasaheb Ambedkar road, Sion

Mumbai
MAHARASHTRA
400022
India 
Phone  9769765309  
Fax    
Email  nrrcproject@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Alka Jadhav  
Designation  Professor Pediatrics  
Affiliation  Lokmanya Tilak Municipal Medical College and General Hospital  
Address  Room no. 120, 1st floor, college building, LTMGH and LTMMC, Dr. Babasaheb Ambedkar road, Sion


MAHARASHTRA
400022
India 
Phone  9769765309  
Fax    
Email  nrrcproject@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Alka Jadhav  
Designation  Professor Pediatrics  
Affiliation  Lokmanya Tilak Municipal Medical College and General Hospital  
Address  Room no. 120, 1st floor, college building, LTMGH and LTMMC, Dr. Babasaheb Ambedkar road, Sion


MAHARASHTRA
400022
India 
Phone  9769765309  
Fax    
Email  nrrcproject@gmail.com  
 
Source of Monetary or Material Support  
ARMMAN 
Lokmanya Tilak Municipal Medical College and General Hospital  
 
Primary Sponsor  
Name  Lokmanya Tilak Municipal Medical College and General Hospital  
Address  Room no. 120, 1st floor, college building, LTMGH and LTMMC, Dr. Babasaheb Ambedkar road, Sion, Mumbai- 400022 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
ARMMAN  47/48, Oasis, 2nd Floor, Nehru Road, Vakola, Santacruz (E), Mumba- 400055 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Alka Jadhav  Nutrition Rehabilitation Research and Training Centre  Room no. 110, Nutrition OPD, Urban Health Centre, Dept. of Pediatrics, 1st floor, 60 feet road, Dharavi, Mumbai- 400017
Mumbai
MAHARASHTRA 
9769765309

nrrcproject@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Human Research. Lokmanya Tilak Municipal Medical College & General Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  No reminder calls  Severely acute malnourished patient in the comparator group will not be receiving reminder calls for their next scheduled visit. 
Intervention  Reminder calls  Severely acute malnourished patient in the intervention group will be receiving reminder calls for their next scheduled visit.  
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  59.00 Month(s)
Gender  Both 
Details  SAM children (6-59 months) admitted at NRRTC on MNT based on any of the following criteria:
1) Weight for Height < -3 SD z-score (SAM)
2) Mid Upper Arm Circumference (MUAC) < 115 cm (SAM)(for children above the age of 6 months)
3) Bilateral pitting oedema.
 
 
ExclusionCriteria 
Details  1) Children with other significant acute as well as chronic underlying disease
2) Children with no access to Phone number or mobile number
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the defaulter rate between patient seeking treatment at NRRTC.  2nd week, 4th week, 6th week, 8th week, 10th week, 12th week 
 
Secondary Outcome  
Outcome  TimePoints 
Rate of recovery between two groups  8th week, 12th week 
 
Target Sample Size   Total Sample Size="385"
Sample Size from India="385" 
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)   02/08/2021 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not published yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

1)    This is a single blinded 2 arm randomized control trial. After identifying the child as severely acute malnourished as per WHO criteria i.e. 1) Weight for height< -3 SD OR 2) Mid upper arm circumference <11.5 cm OR 3) Presence of bilateral pedal oedema of nutritional origin. Instrument like Electronic weighing scale, Infantometer, stadiometer, shakir tapes and WHO growth charts will be used for the anthropometric assessment of the patient. This assessment would be done by NRRTC staff nurse. NRRTC Medical officer would check for any medical complication as per IMCI protocol. If any complication is present the patient would be admitted in pediatric ward 21 and 22. If patient has no complication patient will be given appetite test.

2)      Management of Severe Acute Malnutrition:  Once the patient is enrolled into the program, the patient is started on Medical Nutrition Therapy (MNT). Medical nutrition therapy (MNT) is indigenous Ready to use therapeutic food (RUTF). RUTF is recommended by UNICEF and WHO for treatment of malnutrition. MNT consist of Sugar 28%, Peanut Paste 25%, Skimmed milk powder 24%, Vegetable oil 21%, Vitamins, Minerals, Emulsifier (HP1).

 3)  After passing the appetite test, patient will be called to OPD on weekly bases for 8 weeks to 12 weeks  where he/she will be provided with MNT and patients anthropometry (weight, height and MUAC) would be monitored. After starting the patient on MNT, he/she would be enrolled in either Group A or Group B where Group A will receive reminder calls for the next scheduled visit and Group B will not receive any calls for the visit. Every subject will receive 16 calls maximum. After the enrollment, welcome call will be given. One day prior to the scheduled visit, one call will be done for the period of eight- twelve weeks (till the child is on MNT). After completion of MNT, one call a month will be given to remind about the follow-up for a period of 4 month. The contents in the call will include a) Whether they have continued taking MNT, b) How is the child doing, c) Any fresh problems, d) General guidance about breast feeding and infant young child feeding practises, e) Hygeine and sanitaiton. If the phone is not reachable or picked up, they will be given the reminder on the day of visit. Despite of phone calls if the patient does not visit then one more phone call will be done next day after the scheduled visit date.


 
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