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CTRI Number  CTRI/2017/07/009053 [Registered on: 17/07/2017] Trial Registered Retrospectively
Last Modified On: 12/07/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral
Other (Specify) [Promotion of homestead food production]  
Study Design  Cluster Randomized Trial 
Public Title of Study   Does home gardens improve nutritional intake of young children? 
Scientific Title of Study   Evaluation of the role and impact of participation in homestead food production on the nutritional status of children 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SKiruthika 
Designation  PhD scholar 
Affiliation  National Institute of Nutrition(ICMR) 
Address  Clinical Division,National Institute of Nutrition(ICMR),Jamai Osmania PO,Tarnaka,Hyderabad

Hyderabad
ANDHRA PRADESH
S Kiruthika
India 
Phone  7799348249  
Fax    
Email  kiruthika1411@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bharati Kulkarni 
Designation  Scientist E 
Affiliation  National Institute of Nutrition(ICMR) 
Address  Clinical Division,National Institute of Nutrition(ICMR),Jamai Osmania PO,Tarnaka,Hyderabad

Hyderabad
ANDHRA PRADESH
500007
India 
Phone  9989145570  
Fax    
Email  dr.bharatikulkarni@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Bharati Kulkarni 
Designation  Scientist E 
Affiliation  National Institute of Nutrition(ICMR) 
Address  Clinical Division,National Institute of Nutrition(ICMR),Jamai Osmania PO,Tarnaka,Hyderabad

Hyderabad
ANDHRA PRADESH
500007
India 
Phone  9989145570  
Fax    
Email  dr.bharatikulkarni@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research V. Ramalingaswami Bhawan P.O. Box No. 4911 Ansari Nagar New Delhi - 110029 India 
 
Primary Sponsor  
Name  Indian Council of Medical Reasearch 
Address  Indian Council of Medical Research P.O. Box No. 4911 Ansari Nagar New Delhi - 110029 India 
Type of Sponsor  Government funding agency 
 
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 
S Kiruthika  National Institute of Nutrition(ICMR)  Clinical Division
Hyderabad
ANDHRA PRADESH 
7799348249

kiruthika1411@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee(NIN)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy children less than 5 years of age 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homestead food production will be the intervention targeting households with children less than 5 years of age  The intervention group will receive knowledge and inputs for developing homestead food production.The impact of this intervention on the nutritional status of young children will be compared with the control group, who will not be receiving the intervention. 
Comparator Agent  Households with children less than 5 years of age but not receiving the intervention, will serve as the control group  The control group will not receive the knowledge nor the inputs for developing homestead food production  
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  5.00 Year(s)
Gender  Both 
Details  Every child less than 5 years of age in selected villages of the study area (i.e.)Jangaon 
 
ExclusionCriteria 
Details  1.Children with congenital abnormalities
2.Children suffering with chronic illnesses/diseases
3.Index child is a twin birth 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The intervention may improve the dietary diversity of the household especially among children,thereby, improve their nutrition status.  1.At baseline
2.Followup every 3 months
3.At the end of the project 
 
Secondary Outcome  
Outcome  TimePoints 
Understand the linkages between homestead food production and nutritional status of children  1.At baseline
2.Followup every 3 months
3.At the end of the project 
 
Target Sample Size   Total Sample Size="360"
Sample Size from India="360" 
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 1 
Date of First Enrollment (India)   05/01/2017 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The proposed study will be conducted in collaboration with a local NGO named “Centre for Sustainable Agriculture (CSA)” in Warangal district of Telangana. 

Primary purpose of the study: Promotion of homestead food production among households with young children to improve quality of their diets . Also to understand the linkages between homestead food production  and  nutritional status of children

The intervention: homestead food production will be promoted by Centre for Sustainable Agriculture (CSA) that involves 

1.Distribution of seedlings of micronutrient rich varieties of vegetable and fruits based on availability of space, nature of soil, and exposure of light, time available for care, family size and preferences of the family.

2.Green methods of farming: Organic fertilizers, such as vermicompost, compost from kitchen waste, leaf moulds – and home based pesticide preparations such as green chilli and garlic paste, neem seed kernel extract, mustard garlic solution and vavili leaf decoctions. These techniques will be taught to the participants by experts.

3.Knowledge enhancement: Knowledge on selection of appropriate crops, land preparation, cultivation, raising and harvesting the crops will be provided by experts at CSA as appropriate garden practises are necessary for optimum yield and utilization of the produce

4.Nutrition education will form an important part of the intervention and will be provided  to households in both intervention and control villages. Education materials such as videos, pamphlets, posters, etc will be used to stress on the importance of home consumption of produce such as green leafy vegetables, other vegetables, fruits, milk and milk products, eggs ,meat and meat products among vulnerable members of the family especially the mother and child.

Hypothesis: Homestead food production will improve the dietary diversity and thereby nutritional status of young children.

Expected outcome:

·         Data to be collected will provide information on the effectiveness of an intervention promoting Homestead Food Production for improving dietary diversity and nutritional status of children.

·         The study will also provide information about people’s perception and constraints regarding HFP.

·         The study overall would allow us to extend the intervention in future for effective implementation of such programs in order to improve dietary diversity and nutritional status of children from the rural households.

 
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