| 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
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
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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