| CTRI Number |
CTRI/2017/11/010362 [Registered on: 03/11/2017] Trial Registered Retrospectively |
| Last Modified On: |
02/11/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Interventional package] |
| Study Design |
Other |
|
Public Title of Study
|
“A study to compare Complementary Feeding practices One by One with existing complementary feeding practices on infants |
|
Scientific Title of Study
|
“A comparative study on introduction of Complementary Feeding One by One versus existing complementary feeding practices and their impact on selected outcomes of infants of above 6 months residing 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 |
Bindu Rani |
| Designation |
Student |
| Affiliation |
National Institute of Nursing Education,PGIMER |
| Address |
National Institute of Nursing Education,PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9996960991 |
| Fax |
00911722744401 |
| Email |
bindumor94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushma Kumari Saini |
| Designation |
Lecturer |
| Affiliation |
National Institute of Nursing Education, |
| Address |
National Institute of Nursing Education,PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9888038248 |
| Fax |
00911722744401 |
| Email |
sushmadrsaini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhavneet Bharti |
| Designation |
Professor |
| Affiliation |
department of pediatrics,PGIMER,chandigarh |
| Address |
Department of Pediatrics, Post Graduate Institute of Medical Education and Research, chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087008327 |
| Fax |
00911722744401 |
| Email |
bhavneetsahul@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
National Institute of Nursing Education |
| Address |
National Institute of Nursing Education, Post Graduate Institute of Medical Education and Research, Chandigarh |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Bhavneet Bharti |
Professor, Department of Pediatrics, PGIMER, Chandigarh.ph 7087008327 |
| Dr Sushma Kumari Saini |
Lecturer, National Institute of Nursing Education, PGIMER, Chandigarh . email. sushmadrsaini@gmail.com ph.9888038248 |
| Mrs Kavita |
Lecturer, NINE, PGIMER, Chandigarh ph no. 9872839990
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Bindu Rani |
Dhanas, chandigarh |
Dhanas village,milk colony,Aman and Chaman colony, Kachchi Colony
Chandigarh
CHANDIGARH |
9996960991
00911722744401
bindumor94@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 |
81 infants of age 6 months to 9 months were selected along with their mothers and they were physically healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Complementary Feeding by One by One Food item (one food for 3 days) |
Teaching to mothers by flash cards, Pamphlet containing information regarding complementary feeding in hindi ,Observation and teaching on preparation of Complementary Foods |
| Comparator Agent |
Standard existing complementary feeeding practices |
Existing Complementary Feeding Practices in community |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
9.00 Month(s) |
| Gender |
Both |
| Details |
1. Infants of 6 months of age.
2. Mothers of infants of 6 months of age.
3. Mothers who are willing to participate in the study
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Acceptability and tolerance of recommended complementary foods.
2.Gain in height and weight of the infant.
3. Number of allergy and diarrheal episodes.
|
15/08/17 to 25/11/17
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| none |
none |
|
|
Target Sample Size
|
Total Sample Size="81"
Sample Size from India="81"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="81" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/07/2017 |
| Date of Study Completion (India) |
25/11/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="28" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Complementary feeding
refer to appropriate feeding of solid, semi-solid and soft foods to children
from six months of age and continued breastfeeding for two years or beyond. The
age 6-23 months is a critical period when breast milk alone is no longer
sufficient to meet the increasing nutritional requirements of the infant. the study is done by introducing complementary feeding and that will be done by introducing one food item for three days and
comparing it with the another group in which intervention is not given, so that
the effectiveness will be assessed . |