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CTRI Number  CTRI/2017/03/008273 [Registered on: 31/03/2017] Trial Registered Prospectively
Last Modified On: 31/03/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Screening
Other (Specify) [Education]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Education for mothers on nutritional management of chidren 
Scientific Title of Study   Prevalence and risk factors for malnutrition and effectiveness of need based intervention on nutritional status and cognitive development of preschool children in Anganawadi centers of Udupi District 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ansuya 
Designation  Assistant Professor 
Affiliation  Manipal College of Nursing Manipal 
Address  Department of Community Health Nursing. Manipal College of Nursing Manipal Manipal University

Udupi
KARNATAKA
576104
India 
Phone  9535894558  
Fax    
Email  ansuya.bengre@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Baby S Nayak 
Designation  Professor 
Affiliation  Manipal College of Nursing Mnaipal 
Address  Department of Child health nursing Manipal College of Nursing Manipal Manipal Univeristy

Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  baby.s@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Baby S Nayak 
Designation  Professor 
Affiliation  Manipal College of Nursing Mnaipal 
Address  Department of Child health nursing Manipal College of Nursing Manipal Manipal Univeristy

Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  baby.s@manipal.edu  
 
Source of Monetary or Material Support  
Manipal college of Nursing Manipal, Manipal University Madhava Nagar Udupi 576104 Karnataka, India 
 
Primary Sponsor  
Name  Manipal College of Nursing Manipal 
Address  Manipal University Madhav Nagar, Manipal, Udupi District, Karnataka - 576104 India 
Type of Sponsor  Research institution and hospital 
 
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 Vijayalakshmi U Nayak  Primary Health Centre  Hirebettu PHC Athraady Post Udupi Taluk-576107
Udupi
KARNATAKA 
8277505946

phchirebettu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Kasturba Hospital Manipal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Malnutrition,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Group  No intervention Only observation 
Intervention  Need Based Intervention  Refers to the education provided to the mothers of malnourished children on malnutrion, based on identified modifiable risk factors in the form of lecture and group discussion, followed by demonstration on food preparation which are rich in protein, carbohydrate and zinc according to the requirements of preschool children, locally available, affordable and acceptable to the family in the community. Informational booklet also will be developed and distributed for the parents 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  Children and their mothers attending Anganawadis
Children and mothers who are available during data collection and willing to participate
Children with moderately and severely underweight and their mothers.
 
 
ExclusionCriteria 
Details  Children who are known case of systemic illness such as cardiac problems, renal problems etc. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Nutritional status
Cognitive development 
1st month and 6th month  
 
Secondary Outcome  
Outcome  TimePoints 
NA  NOT APPLICABLE 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
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   Phase 2 
Date of First Enrollment (India)   05/05/2017 
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   So far no publications 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Introduction

Child malnutrition is a wide spread public health problem having international consequences because good nutrition is an essential determinant for their well-being. The most neglected form of human deprivation is malnutrition, particularly among preschool children. India is one of the few countries in the world where poor nutritional status among preschool children is detrimental to their health outcome.

Malnutrition is a condition that develops when the body does not get the proper amount of protein, energy, vitamins and other nutrients. Malnutrition is technically a category of diseases that includes: undernutriiton, over nutrition and micronutrient deficiencies. Malnutrition occurs in children who are either undernourished or over nourished. In most of the world, malnutrition is present in the form of undernutriiton, which is caused by a diet lacking adequate calories and protein.

Under nutrition reflects a number of intermediary processes such as household access to food, access to health services and caring practices. In India, since a large number of people are poor, illiterate and ignorant of the importance of hygiene and sanitation, they consume inadequate amount of nutrients and suffer from infections that result in poor utilization of nutrients which leads to under nutrition. This form of malnutrition is more common in our country.

 UNICEF classifies the immediate causes of childhood malnutrition as insufficient diet as well as stress, trauma, frequent infections and poor psychosocial care. Insufficient dietary intake may refer to poor breastfeeding practices, early weaning, delayed introduction of complementary foods and insufficient protein in the diet.  Other factors that influence food intake include health status, food taboos, growth and personal choice related to diet. Malnutrition can also develop due to neglect, abnormal mealtimes with a carer or parent or insufficient quantities of food. Because of insufficient parental knowledge, poor appetite in the child or neglect, physical or emotional abuse, sometimes the mother restricts the child’s food intake.

The effect of undernutriiton on young children (ages 0-8) can be devastating and enduring. Delayed physical growth and motor development. It can impede behavioral and cognitive development, lower educational achievement, deficient social skills, decreased attention, deficient learning and reproductive health, thereby undermining future work productivity. Malnutrition in early childhood has serious, long-term consequences; it increases morbidity, greater risk of disease and early death.

Background of the study

Global scenario of Malnutrition: Globally it is estimated that under nutrition is responsible, directly or indirectly, for at least 35% of deaths in children less than five years of age. More than a quarter of World’s children are still malnourished – 26.7% (150million) children are underweight and 32.5% (182 million) stunted of whom 70% are in Asia, 26% in Africa and 4% in Latin. An estimated 32% or 186 million, children below five of age in developing countries are stunted and about 10% or 55 million are wasted.

UNICEF states that the highest level of underweight children are found in South Asia, involving 46% of all under-fives in the region. There are more than 6 million preventable child deaths every year in developing countries. Unfortunately, this is the tip of the iceberg. Estimated that, more than 200 million underfive children who fail to reach their potential in cognitive development because of poor health and nutrition and deficient care.

Malnutrion in India:

More than half of World’s malnourished children live in India. Malnutrition is a major public health emergency in India today. It is estimated that, 57 million children are underweight (moderate and severe). India has a high prevalence of PEM about 50% of the population suffering from it in some form - protein-calorie deficit and/or micro-nutrient malnutrition. 46% of Indian children under 6 years are underweight, and 38% are short for their age. It is the underlying cause of at least 50% of deaths of under -five children in the country.

WHO world health statistics (2009) revealed 43.5% underweight underfive in India and 39.8% in Bangladesh among SEAR which are high prevalence in the world also. In India the prevalence of undernutriiton is the highest in Madhya Pradesh (55%), followed by Bihar (54%), Orissa (54%), Uttar Pradesh (52%) and Rajasthan (51%), while Karnataka (41%), Kerala (37%) and Tamil Nadu (27%).

Malnutrition in Karnataka:

The findings of the third National Family Health Survey (NFHS-3) reveals an unacceptable prevalence of malnutrition among children:42.5% of children under the age of five years are underweight (low weight for age), 48 % are stunted, 19.8%  are wasted. In poorer states the situation is even worse with over 50 % of children underweight.

2.1 million children are mildly malnourished, 1.13 million are moderately malnourished and 71,605 are severely malnutrition children in Karnataka.8According to data provided by women and child welfare department, 2,689 children have died due to malnutrition, of which 811 died in 2009 and 1,233 in 2010. As many as 645 such deaths have been recorded till August 2011.Over 4,531 number of children suffering from severe malnutrition and 2,600 children died of malnutrition in Raichur District of Karnataka.

A cross sectional study was conducted on prevalence of malnutrition among preschool children in Azad Nagar, Bangalore.  The prevalence of malnutrition among children was 68%. Among that, male children malnutrition was 57.94% and females 42.06%.

 

Malnutrition in Udupi :

A cross-sectional study was conducted in 11 villages of the field practice area of Community Medicine Department of Manipal in Udupi taluk among Anganawadi children.  Result showed that, 32.3% children are malnourished. Proportionally girls (46.2%) were more malnourished than boys (33.6%).

A case control study was carried out among under five children in Udupi taluk. Study found under-nutrition was associated with illness in the last one month , feeding diluted milk and having more than two children with a birth interval < 2 years.  Study concluded that, childhood illness, short birth interval, mothers negligence about diet and consumption of diluted milk were significant contributory factors.

On July 3rd 2012, as per District Health Officer, Udupi, 371 children who are less than 6years of age, in the district are suffering of malnutrition. According to report from CDPO, Udupi (August 2012), a total 7859 underfive children were malnourished, 649 children were severely malnourished in Udupi district.

Malnutrition and cognitive development:

Bhoomika R Kar (2007) conducted study on malnourished children in NIMHANS, Banglore. Cognitive development was assessed by using Gessell’s developmental schedule. Children with grade II and III malnutrition had poor development in all areas of behaviour ie. motor, adaptive, language and social development.

Agarwal DK, Upadhyay SK, Agarwal KN (1989) conducted a study among rural children studying in primary school in Banglore between the age of 6-8 years were assessed on measures of social maturity. Study found, malnutrition was associated with deficits of social competence, visuo-motor coordination and memory. IQ scores decreased with the severity of malnutrition.

Thus present study intends to assess the prevalence and identify the risk factors for malnutrition and provide need based intervention such as education, food demonstration and counseling to mothers to improve nutritional status and cognitive development of preschool children.

Problem statement:

“Prevalence and risk factors for malnutrition and effectiveness of need based intervention on nutritional status and cognitive development of preschool children in Anganawadi centers of Udupi District”.

Purpose of the study:

To identify the prevalence and risk factors of malnutrition among preschool children. Study also aims to find out the effect of need based intervention to mothers of malnourished preschooler on modifying the various factors, which will further help to improve the nutritional status and cognitive development of preschool children.

Objectives:

The objectives of the study are to :

 identify the prevalence of malnutrition among preschool children

 Identify the risk factors for  malnutrition among preschool children.

 determine the effectiveness of need based intervention in terms of

·         changes in nutritional status of malnourished preschool children.

·         changes in cognitive development  of malnourished preschool children.

 

Hypotheses:

Will be tested at 0.05 level of significance

·         There will be a significant difference in the pre and posttest measurement of nutritional status and cognitive development of malnourished preschool children in intervention group.

·         The posttest measurement of nutritional status of malnourished preschool children in the intervention group will be significantly higher than control group.

·         The posttest cognitive development of malnourished preschool children in the interventional group will be significantly higher than the control group.



 
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