| CTRI Number |
CTRI/2018/01/011451 [Registered on: 19/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
16/01/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Other |
|
Public Title of Study
|
A comparative study on management of malnourished children (1-5 years) with home-based and facility based intervention on nutritional status of malnourished children. |
|
Scientific Title of Study
|
A comparative study on management of malnourished children (1-5 years) with home-based and facility based intervention on nutritional status of malnourished children in the selected area of Dhanas ,UT Chandigarh, 2016-2018. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pabalpreet Kaur |
| Designation |
MSc Nursing Student |
| Affiliation |
|
| Address |
National Institute of Nursing Education PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8264619073 |
| Fax |
00911722744401 |
| Email |
pabalpreet@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSushma Kumari Saini |
| Designation |
lecturer |
| Affiliation |
|
| Address |
National Institute of Nursing Education PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9888038248 |
| Fax |
00911722744401 |
| Email |
sushmadrsaini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Suresh kumar |
| Designation |
Clinical instructor |
| Affiliation |
|
| Address |
National Institute of Nursing Education PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9855487722 |
| Fax |
00911722744401 |
| Email |
SKumarbamania@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
National Institute of Nursing Education |
| Address |
National Institute of Nursing Education PGIMER |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Pabalpreet Kaur |
Dhanas, Chandigarh |
Dhanas village chaman colony Aman colony Ambedkar colony milk colony housing board-I & II Dhanas new colony
Chandigarh
CHANDIGARH |
8264619073
00911722744401
pabalpreet@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee(intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
152 malnourished children of age 1-5 years were selected along with their mothers and they were physically healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
facility based intervention to combat malnutrition |
Group of mothers (3-4 mothers in a group) was having interactions at anganwadi centers with the investigator, Assessment of feeding practices by interview schedule was done, Demonstration on cooking and feeding was given, Health education regarding cooking, feeding and nutrition was given.
|
| Intervention |
home based intervention to combat malnutrition |
One by one interaction at home with mothers of malnourished children was done by the investigator,Assessment of feeding practices by interview schedule was done, Demonstration on cooking and feeding was given.
Health education regarding cooking, feeding and nutrition was given.
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
mothers who are willing to participate in the study.
who understands Hindi and punjabi. |
|
| ExclusionCriteria |
| Details |
not willing to participate. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improvement in the nutritional status of malnourished children |
1/11/2017-24/11/2017 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| none |
none |
|
|
Target Sample Size
|
Total Sample Size="152"
Sample Size from India="152"
Final Enrollment numbers achieved (Total)= "152"
Final Enrollment numbers achieved (India)="152" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2017 |
| Date of Study Completion (India) |
22/11/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="21" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Child growth is internationally recognized as an important indicator of nutritional status and health in populations. Underweight: weight for age < –2 standard deviations (SD) of the WHO Child Growth Standards median. the study is done by comparing two intervention to combat malnutrition . in home based intervention One by one interaction at home with mothers of malnourished children was done by the investigator, Assessment of feeding practices by interview schedule was done, Demonstration on cooking and feeding was given, Health education regarding cooking, feeding and nutrition was given and In facility based intervention Group of mothers (3-4 mothers in a group) was having interactions at anganwadi centers with the investigator, Assessment of feeding practices by interview schedule was done, Demonstration on cooking and feeding was given, Health education regarding cooking, feeding and nutrition was given. |