| CTRI Number |
CTRI/2024/05/067216 [Registered on: 13/05/2024] Trial Registered Prospectively |
| Last Modified On: |
10/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Complementary Feeding Practices and Associated Factors among Children in an urban slum of Delhi |
|
Scientific Title of Study
|
Complementary Feeding Practices and Associated Factors among Children in an urban slum of Delhi: A Cross Sectional Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bibhu |
| Designation |
Postgraduate student |
| Affiliation |
Maulana Azad Medical College |
| Address |
3rd Floor, Pathology Block, Department of Community Medicine, Maulana Azad Medical College, Bahadur Shah Zafar Marg, Balmiki Basti, New Delhi
Central
DELHI
110002
India |
| Phone |
9555727146 |
| Fax |
|
| Email |
bibhu075@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shivani Rao |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
room no 337, 3rd Floor, Pathology Block, Department of Community Medicine, Maulana Azad Medical College, Bahadur Shah Zafar Marg, Balmiki Basti, New Delhi
Central
DELHI
110002
India |
| Phone |
9650729724 |
| Fax |
|
| Email |
shivani.idsp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shivani Rao |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
room no 337, 3rd Floor, Pathology Block, Department of Community Medicine, Maulana Azad Medical College, Bahadur Shah Zafar Marg, Balmiki Basti, New Delhi
Central
DELHI
110002
India |
| Phone |
9650729724 |
| Fax |
|
| Email |
shivani.idsp@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College, Bahadur Shah Zafar Marg, Balmiki Basti, New Delhi-110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Bahadur Shah Zafar Marg, Balmiki Basti, New Delhi-02 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Bibhu |
UHTC, Gokalpuri, Under the department of Community Medicine, Maulana Azad Medical College |
A-120, Ganga Vihar Road, Block-C, Gokalpuri, New delhi
North East
DELHI |
9555727146
bibhu075@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College and associated hospitals Institutional ethic committee Ethic Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Target population: Children 6m - 23m of age |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
23.00 Month(s) |
| Gender |
Both |
| Details |
All children between 6 months to 23 months of age having mother as an informant |
|
| ExclusionCriteria |
| Details |
•Child suffering from acute serious illness/ chronic medical illness or congenital anomaly.
•Informant with any diagnosed psychological illness.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
•Primary Outcomes:
1.Proportion of children who have initiated the Introduction of Solid, Semisolid or Soft Foods (ISSSF) at the age of 6 months to 8 months.
2.Proportion of children following Minimum Dietary Diversity (MDD) in 6 months to 23 months.
3.Proportion of children following Minimum Meal Frequency (MMF)
4.Proportion of children following Minimum Acceptable Diet (MAD)
|
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•Secondary Outcome:
Associated factors (socio-economic & demographic such as age of mother, gender of child, family size, type of family, occupation of mother & father etc.) affecting the feeding practices of children living in an urban area of Delhi
|
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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
|
N/A |
|
Date of First Enrollment (India)
|
21/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
21/05/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
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
|
Aim:
To assess the complementary feeding
practices and associated factors among children in an urban slum of Delhi.
Study Area: Field practice area of Urban
Health & Training Centre of Gokalpuri.
Study Population – Children
between 6 months to 23 months of age
Lacuna : Limited evidence is
available on the prevalence and factors associated with complementary feeding
practices for guiding policy actions in India.
|