| CTRI Number |
CTRI/2024/06/069571 [Registered on: 26/06/2024] Trial Registered Prospectively |
| Last Modified On: |
24/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of nutritional counselling of mothers on the feeding practices of their infants |
|
Scientific Title of Study
|
Effect of nutritional counselling of mothers on the complementary feeding practices of their infants in an urban resettlement colony of Shahdara district: a quasi-experimental 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 |
NIHARIKA |
| Designation |
Post-graduate resident |
| Affiliation |
University College of Medical Sciences and Guru Teg Bahadur Hospital |
| Address |
Room no. 416, Department of Community Medicine, Fourth Floor, University College of Medical Sciences
North East
DELHI
110095
India |
| Phone |
8810516271 |
| Fax |
|
| Email |
1bniharika1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PRAGTI CHHABRA |
| Designation |
Director Professor |
| Affiliation |
University College of Medical Sciences |
| Address |
Fourth Floor, Department of Community Medicine, University College of Medical Sciences
North East
DELHI
110095
India |
| Phone |
9811687966 |
| Fax |
|
| Email |
pragschhabra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PRAGTI CHHABRA |
| Designation |
Director Professor |
| Affiliation |
University College of Medical Sciences |
| Address |
Fourth Floor, Department of Community Medicine, University College of Medical Sciences
North East
DELHI
110095
India |
| Phone |
9811687966 |
| Fax |
|
| Email |
pragschhabra@gmail.com |
|
|
Source of Monetary or Material Support
|
| University College of Medical Sciences and Guru Teg Bahadur Hospital, Dilshad Garden, East Delhi, India, Pincode - 110095 |
|
|
Primary Sponsor
|
| Name |
University College of Medical Sciences and Guru Teg Bahadur Hospital |
| Address |
2, Tahirpur Rd, GTB Enclave, Dilshad Garden, New Delhi, Delhi, 110095 |
| 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 Niharika |
University College of Medical Sciences |
Room no. 416, Fourth Floor, Department of Community Medicine, College Building.
North East
DELHI |
8810516271
1bniharika1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE – HUMAN RESEARCH (IEC-HR) UNIVERSITY COLLEGE OF MEDICAL SCIENCES, UNIVERSITY OF DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Malnutrition |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Family counselling |
Two rounds of family planning counselling, of mothers enrolled in anganwadis for the control group, over a period of 4-6 months. |
| Intervention |
Nutritional counselling of mothers |
Two rounds of group Counselling of mothers enrolled in anganwadis, in adherence to the Infant and Young Child Feeding Practices regarding complementary feeding over 4-6 months period. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Month(s) |
| Age To |
5.00 Month(s) |
| Gender |
Both |
| Details |
1.Mother and child dyads where the child aged 3-5 months is enrolled in Anganwadi.
2.Resident of Nand Nagri for at least past 6 months, not planning to shift for at least the duration of the study.
|
|
| ExclusionCriteria |
| Details |
1. Mothers who have already started complementary feeding this child.
2. Children with any congenital anomaly and/or feeding difficulty.
Mothers with significant language barrier making counselling difficult. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess the effect of nutritional counselling on quality and quantity of complementary feeding of infants using minimum diet diversity (MDD), minimum meal frequency (MMF) and minimum acceptable diet (MAD) by comparing the intervention group with the control group.
2.To assess the effect of nutritional counselling on the consumption of unhealthy foods and sweetened beverages.
|
When the children attain 9 months of age |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the difference (if any) in the time of initiation of complementary feeding in the intervention and control groups of the study as a result of nutritional counselling. |
When the children attain 9 months of age. |
| To assess the difference (if any) in adoption of various responsive feeding methods as a result of nutritional counselling between the two groups. |
When the children attain 9 months of age. |
| To study the association of socio-demographic profile of the mother and the family with the complementary feeding practices |
Towards the end of the study |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="91" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/07/2024 |
| Date of Study Completion (India) |
20/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="5"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
TITLE: Effect of nutritional counselling of mothers on the complementary
feeding practices of their infants in an urban resettlement colony of Shahdara
district: a quasi-experimental study.
AIM: To improve the quality and
quantity of complementary feeding of infants through nutritional counselling of
mothers in an urban resettlement colony in Shahdara district of Delhi.
OBJECTIVES:
Primary Objectives:
1. To assess the effect of nutritional counselling on
quality and quantity of complementary feeding of infants using minimum diet
diversity (MDD), minimum meal frequency (MMF) and minimum acceptable diet (MAD)
by comparing the intervention group with the control group.
2. To assess the effect of nutritional counselling on the
consumption of unhealthy foods and sweetened beverages.
Secondary Objectives:
1. To assess the difference (if any) in the time of
initiation of complementary feeding in the intervention and control groups of
the study as a result of nutritional counselling.
2. To assess the difference (if any) in adoption of
various responsive feeding methods as a result of nutritional counselling between
the two groups.
3. To study the association of socio-demographic profile
of the mother and the family with the complementary feeding practices.
STUDY SETTING: The study will be
conducted in the Anganwadis of Nand Nagri, an urban resettlement colony in
Shahdara district of Delhi.
STUDY AREA: Nand Nagri is an urban resettlement colony in
Shahdara district of Delhi. It is divided into five blocks which are comprised
of a total 21 sub-blocks. Each sub-block is made up of approximately 500
houses. Each block of Nand Nagri has about 9-10 Anganwadis.
STUDY DESIGN: This shall be a
community based quasi-experimental study.
SAMPLE SIZE: A
study on effect of nutritional counselling on the MAD was done in tribal
district of Palghar, Maharashtra by Surve et al, which found the MAD to be
5.32%, and 47.2% in the control and intervention group respectively.[21] Assuming that our study will result in
similar improvement in MAD, and keeping the significance level of the study at
95%, power at 80%, applying a design effect of 2, and accounting for an
attrition of 10%, the sample size came out to be 40 in each group (intervention
and control), totalling to 80.
STUDY TOOLS:
1.
A self-prepared,
pre-tested, structured, interviewer administered proforma for recording
socio-demographic details.
2.
Information and
education material for nutritional counselling and responsive feeding from the
IYCF training module by Breastfeeding Promotion Network of India (BPNI).
3.
WHO 24- hour
dietary recall questionnaire for dietary assessment and intake of unhealthy
foods and sweet beverages.
4.
A self-prepared, pre-tested,
structured questionnaire for assessing responsive feeding practices.
5. 5. A weighing scale
and infantometer for anthropometry (weight and length). |