| CTRI Number |
CTRI/2024/06/068427 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
07/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [ Nutrition and behavioral] |
| Study Design |
Other |
|
Public Title of Study
|
Improving feeding practices through involving frontline workers |
|
Scientific Title of Study
|
Improving Infant and young child Feeding (IYCF) practices in Tribal block of Palghar District, Maharashtra through involvement of frontline workers. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suchitra Surve |
| Designation |
Scientist D |
| Affiliation |
ICMR-National,Institute forReserach in reproductive and Child Health |
| Address |
National Institute for Research in Reproductive Health, Jehangir Merwanji Street, Parel, Mumbai-400 012
ICMR-National Institute for Research in Reproductive Health, Jehangir Merwanji Street, Parel, Mumbai-400 012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224192029 |
| Fax |
|
| Email |
dr.suchi172@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Suchitra Surve |
| Designation |
Scientist D |
| Affiliation |
ICMR-National,Institute forReserach in reproductive and Child Health |
| Address |
National Institute for Research in Reproductive Health, Jehangir Merwanji Street, Parel, Mumbai-400 012
ICMR-National Institute for Research in Reproductive Health, Jehangir Merwanji Street, Parel, Mumbai-400 012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224192029 |
| Fax |
|
| Email |
dr.suchi172@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrRagini Kulkarni |
| Designation |
Scientist F |
| Affiliation |
ICMR-National,Institute forReserach in reproductive and Child Health |
| Address |
Department of Operational and Implementational Research
ICMR-NIRRCH
J M Street,Parel
Department of Operational and Implementational Research
ICMR-NIRRCH
J M Street,Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224192115 |
| Fax |
|
| Email |
kulkarnir@nirrch.res.in |
|
|
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 Research |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911
Ansari Nagar, New Delhi - 110029, India |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrRagini Kulkarni |
Model Rural Research health Unit,Dahanu |
Model Rural Reserach health Unit, Dahanu
Palghar District
Thane
MAHARASHTRA |
02224192115
kulkarnir@nirrch.res.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ICMR-NIRRCH ETHICS COMMITTEE FOR HUMAN STUDIES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Mothers and infants |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Nutrition and behavior |
Training and education of frontline workers and mothers, Preparation of IEC,PICTORIAL CHARTS, Videos,Hot cooked meal as complementary feed at Anaganwadies, Supplementation of Iron and Calcium supplements
Duration-12 months |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
12.00 Month(s) |
| Gender |
Both |
| Details |
Inclusion Criteria
1.All infants in the age group of 6 to 12 months
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria
1.Babies with chronic illness, having comorbidities, with underlying illnesses
2.chronic illness,
3.SAM, MAM CHD, Birth defects – Cleft lip, palate etc |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Percentage of infants who are exclusively breast fed
2.Percentage of infants who have received continued breastfeeding at 2 year 3. % of infants received solid, semi-solid /soft foods from 6 months?? 4. % of infants achieved MDD, MMF, MAD
5. % of infants Consumption of iron rich foods
6. % of infants received iron, calcium and vitamin D supplements
7. % age of ASHAs/ AWW aware about optimal IYCF practices
|
24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Percentage of of infants SAM & MAM , stunting, undernutrition |
24 months |
|
|
Target Sample Size
|
Total Sample Size="460"
Sample Size from India="460"
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)
|
17/06/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Under nutrition mainly prevails in first 2 years of life as this period includes period of initiation of complementary feeding (Weaning). Tribal population are particularly vulnerable to under nutrition, because of their geographical isolation, socio-economic disadvantage and inadequate health facilities. Identifying approaches to reduce the prevalence of malnutrition is a priority in developing countries as suboptimal child feeding practices including inappropriate breastfeeding and complementary feeding practices are leading causes of under nutrition and mortality during the first 2 years of life. Several studies done so far in Indian population have shown that inappropriate infant and young child feeding practices (IYCF) and under nutrition are higher among tribal population. However, no studies have yet been reported from Palghar block of Maharashtra focusing on infant and young child feeding practices in tribal block. Very limited evidence exists on improving full spectrum of IYCF practices and the impact and operational aspects of CFS in India. The implementation gaps between feeding practices need to be addressed by strengthening and upgrading skills of the existing healthcare staff to bridge the gap between community and the policy to make them more approachable and resourceful to improve the nutritional status of the children in the country. The preliminary findings of study at Palghar district point towards the need of establishing a long term sustainable model of Infant and young child feeding practices especially focussing on complementary Feeding through involvement of front line workers such as ASHAs, Anganwadi workers and ANMs. The present study is therefore planned in two PHCs of Dahanu block of Palghar District to assess baseline infant young child and feeding practices in selected PHCs of Dahanu block of Palghar District, to design and implement intervention package on basis of baseline findings and comparing nutritional status and WHO IYCF indicators in case and control PHCs of Dahanu block. |