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CTRI Number  CTRI/2018/04/013068 [Registered on: 05/04/2018] Trial Registered Retrospectively
Last Modified On: 27/03/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross sectional, case control study 
Study Design  Other 
Public Title of Study   A study regarding quality of life in children with severe malnutrition in the age group 5 to 12 years. 
Scientific Title of Study   Study regarding the Quality of Life in children with Severe Acute Malnutrition. 
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  alkaraja1@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Laxmi T 
Designation  M.D. Pediatrics 
Affiliation  Lokmanya Tilak Municipal Medical College and General Hospital 
Address  College building, LTMGH and LTMMC, Dr. Babasaheb Ambedkar road, Sion

Mumbai
MAHARASHTRA
400022
India 
Phone  7738201231  
Fax    
Email  tlakshmi889@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Laxmi T 
Designation  M.D. Pediatrics 
Affiliation  Lokmanya Tilak Municipal Medical College and General Hospital 
Address  College building, LTMGH and LTMMC, Dr. Babasaheb Ambedkar road, Sion

Mumbai
MAHARASHTRA
400022
India 
Phone  7738201231  
Fax    
Email  tlakshmi889@gmail.com  
 
Source of Monetary or Material Support  
UNICEF, 35, Mahakali Caves Rd, Hanuman Nagar, Andheri East, Mumbai, Maharashtra 400053 
 
Primary Sponsor  
Name  UNICEF 
Address  35, Mahakali Caves Rd, Hanuman Nagar, Andheri East, Mumbai, Maharashtra 400053 
Type of Sponsor  Other [Non-governmental organization] 
 
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 
Dr Alka Jadhav  Nutritional Rehabilitation, Research and Training Centre  NRRTC, Urban health centre (Chota sion hospital), Room no. 108, Dept of Pediatrics, Ground floor, 60 feet road, Dharavi
Mumbai
MAHARASHTRA 
9769765309

alkaraja1@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Lokmanya Tilak Municipal College and General Hospital - Staff and Research Society  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Severe Acute Malnutrition,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Quality of life  Physical Functioning, Social Functioning, Emotional Functioning and School Functioning 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1) children with severe thinness in the age group 5-12 years
2) Age, sex, socio-economic and culturally matched healthy children as controls.  
 
ExclusionCriteria 
Details  1) Children with severe thinness who were chronically ill or immunocompromised.
2) Mentally unstable children who were severely thin.
3) Children with oncological and neurological illness.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the functioning of SAM children with respect to physical, emotional, social
and psychological wellbeing with the help of PedsQL questionnaire.  
Day 1 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the impact of social and demographic factors on the quality of life in children with severe thinness.
 
Day 1 
 
Target Sample Size   Total Sample Size="105"
Sample Size from India="105" 
Final Enrollment numbers achieved (Total)= "105"
Final Enrollment numbers achieved (India)="105" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/07/2015 
Date of Study Completion (India) 29/12/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 29/12/2016 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Children between 5 to 12 years of age admitted in the Pediatrics ward and also those

children coming to the outpatient department, were diagnosed as severe thinness after

an anthropometric screening. Every alternate child diagnosed as severe thinness was

included in the study group after ruling out other chronic illnesses (except tuberculosis).

Age and sex matched healthy siblings of these children and other children hospitalized

for various illnesses, with normal nutritional status were included as controls. A written

informed consent from the parents (Annexure III) and ascent of the patient was

obtained.

A detailed history including demographic information such as age, gender , socio

economic status(SES) and community was recorded in a predesigned case record form

(Annexure IV).A detailed dietary history, birth history, immunization history and

developmental history were also obtained.              

The socioeconomic status was categorized using Kuppuswamy  Scale .

A detailed general physical examination ( including associated clinical findings like anemia,

clubbing, pedal edema) and systemic examination was done with special emphasis on

anthropometric measurements and nutritional status which was derived based on weight and

height. Weight was determined using electronic weighing scale and height was determined by

stadiometer.Body Mass Index was calculated using the formula( weight in kg)/( height in

metre)2        

Children with BMI for age less than or equal to three standard deviations WHO 2007 reference

value were designated to have Severe Thinness . Those children falling between two and

three standard deviations below the median were designated to have Thinness. The height for

age and weight for age less than or equal to three standard deviations were designated as

severely stunted and severe underweight respectively. Those falling between two and three

standard deviations below the median were designated as stunted and moderately under

weight respectively 

Baseline investigations including complete hemogram, liver function test ( SGOT/SGPT ,

serum albumin) , renal function test ( blood urea nitrogen / serum creatinine) were done.

Special investigations : chest xray,sputum for AFB, mantoux, USG abdomen , CT scan

chest/abdomen were done as indicated. These investigations were reviewed and documented.

The quality of life assessment was performed using the Pediatric Quality of Life Inventory

(PedsQL) 4.0 Generic Core Scale. A user agreement was signed with the MAPI research

Institute, Lyon, France, prior to the use of the questionnaire. The Peds QoL4.0 Generic Core

Scale includes parallel child self-reports and parent proxy-reports (Annexure VI). We used this

questionnaire in 3 languages, UK English, Hindi and Marathi. Two separate questionnaires

were administered for children aged 5 to 7 years and 8 to 12 years. Children between 7 to 8

years were given the questionnaire used by children in the age group 8 to 12 years. These

were completed independently by children and their parents.

Peds QoL items ask how much of a problem a particular issue has been for the patient during

certain period. Item responses are measured on 5 point rating scale ranging from 0 (almost

always problem) to 100 (never a problem). These 23 items consist of 8 items on physical

functioning, 5 on emotional, 5 on social, and 5 on school ,yielding a total score ranging from 0

to 100 with higher score indicating higher quality of life (83)(54). Additionally, the Peds QoL 4.0

questionnaire contains a Psychosocial Health Summary score which represents the sum of

items over the number of items answered in the emotional, social and school functioning

scales.

The scores for each dimension are calculated as follows: the mean score is represented by the

sum of the items over the number of items answered; missing values are replaced by the

mean score of the remaining items; if more than 50% of the items in a given scale are missing,

the scale scores are not computed. Raw scores are transformed into standardized scores on a

scale from 0 to 100 with higher scores representing higher functioning levels.

The reliability, internal consistency and validity of the PedsQL questionnaire have been

assessed in pediatric populations with acute and chronic health conditions, besides in

physically healthy pediatric populations.

A study of physical, social, emotional and scholastic scores was performed on children

between 5 and 12 years with severe thinness and it was compared against the same

for normal children in the same age group. For children who were hospitalized, they

were interviewed after recovering from acute illness and before discharge from hospital.

Also the socio-economic status of the child and his parents (parent’s education,

occupation and income) and the basic details (age/gender/community/presenting

complaints etc) were collected and compared. The sample size was estimated as 60

subjects and 45 controls (Total = 105). Socio-demographic variables were recorded

and the HRQOL was assessed with PedsQL 4.0.  

 
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