| 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
|
|
|
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. |