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CTRI Number  CTRI/2025/02/080670 [Registered on: 17/02/2025] Trial Registered Prospectively
Last Modified On: 31/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Qualitative study 
Study Design  Other 
Public Title of Study   How culture shapes mealtime habits of young children of age 5-7 years in a metropolitan city in Maharashtra 
Scientific Title of Study   Cultural variation in feeding occupation of children in the age group of 5 to 7 years in metropolitan city in Maharashtra an exploratory qualitative study 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
EC/129/2023 version 3 30/08/23  Protocol Number 
Protocol version 3.0  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrHemant Nandgaonkar 
Designation  Assistant Professor 
Affiliation  Seth G.S. Medical College and KEM Hopsital 
Address  1st Floor,KEM Orthopaedic centre, Dr Ernest Borges Rd, opposite TATA MEMORIAL HOSPITAL, Parel East, Parel, Mumbai, Maharashtra Seth GSMC and KEMH Occupational Therapy School and Centre Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9819660953  
Fax    
Email  hemantnandgaonkar@kem.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr nidhi mishra 
Designation  Occupational Therapist 
Affiliation  Seth G.S. Medical College and KEM Hopsital 
Address  1st Floor,KEM Orthopaedic centre, Dr Ernest Borges Rd, opposite TATA MEMORIAL HOSPITAL, Parel East, Parel, Mumbai, Maharashtra Seth GSMC and KEMH Occupational Therapy School and Centre Mumbai


MAHARASHTRA
400012
India 
Phone  9167273438  
Fax    
Email  Nidhimishra@kem.edu  
 
Details of Contact Person
Public Query
 
Name  DrHemant Nandgaonkar 
Designation  Assistant Professor 
Affiliation  Seth G.S. Medical College and KEM Hopsital 
Address  1st Floor,KEM Orthopaedic centre, Dr Ernest Borges Rd, opposite TATA MEMORIAL HOSPITAL, Parel East, Parel, Mumbai, Maharashtra Seth GSMC and KEMH Occupational Therapy School and Centre Mumbai


MAHARASHTRA
400012
India 
Phone  9819660953  
Fax    
Email  hemantnandgaonkar@kem.edu  
 
Source of Monetary or Material Support  
1st Floor 412 occupational therapy department seth gs College kem Mumbai 400012 Maharashtra  
 
Primary Sponsor  
Name  DrHemant Nandgaonkar 
Address  20 pushpanjali,goshala road, mulund west Mumbai 400080 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Nidhi mishra  3/8, samatali, Jaihind Nagar, Pipe line, Khar east, Mumbai 400051. 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrHemant nandgaonkar  Seth G.S. Medical College  1st Floor,KEM Orthopaedic centre, Dr Ernest Borges Rd, opposite TATA MEMORIAL HOSPITAL, Parel East, Parel, Mumbai, Maharashtra Seth GSMC and KEMH Occupational Therapy School and Centre Mumbai
Mumbai
MAHARASHTRA 
9819660953

hemantnandgaonkar@kem.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee(IEC)II relating to biomedical and health research (BHR) Seth G.S medical College and KEMH Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Normal pediatric population  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Na  Na 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  7.00 Year(s)
Gender  Both 
Details  Parents of typically developing children in the age group of 5-7
years, who are willing to participate
Parents in nuclear and joint families from different ethnicities
and socio-economic backgrounds are included in the study
Parents who are staying in Mumbai Suburban for at least 5
years 
 
ExclusionCriteria 
Details  Parents of children who arent willing to participate in the study
Children with any congenital anomalies 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To explore Cultural variation in feeding occupation of children, age
group of 5 to 7 years in Mumbai 
One time 
 
Secondary Outcome  
Outcome  TimePoints 
Na  Na 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   26/02/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   Title:
*Cultural Variation in Feeding Occupation of Children in the Age Group of 5 to 7 Years in a Metropolitan City in Maharashtra: An Exploratory Qualitative Study*

Introduction
The study focuses on the influence of cultural variation on feeding occupations in children aged 5–7 years in Mumbai. Feeding practices are shaped by cultural, social, and economic factors. Parental feeding beliefs and practices vary across cultures and impact children’s eating behaviors, preferences, and health outcomes. 

Key insights include:  
- Parents’ feeding practices reflect cultural values and customs, sometimes clashing with mainstream norms.  
- Feeding behaviors like pressuring children to eat or restricting food intake may negatively influence eating habits and health outcomes.  
- Socio-economic factors and ethnicity influence feeding practices, including the choice of traditional or modern foods.  

Occupational therapists need to understand these cultural differences to design effective interventions promoting healthy eating in children.

Research Questions

Primary Research Question:
How does cultural variation affect the feeding occupation of children aged 5 to 7 years in a metropolitan city in Maharashtra?  

Secondary Questions:
Not applicable.  


Objectives
Primary Objective:
To explore the cultural variations in feeding occupations of children aged 5–7 years in Mumbai.  

Secondary Objective:
To investigate precursors and contextual influences on parental feeding practices and knowledge about the childcare food environment.  


Methodology

Study Design:
This is an exploratory qualitative study aimed at understanding feeding occupations through participants’ lived experiences.  

Study Duration:
18 months, from November 2023 to April 2025.  

Study Setting:
Data will be collected from caregivers in their home settings.  

Sampling Technique:
Purposive sampling to ensure diverse representation of ethnic and socio-economic backgrounds.  

Sample Size:
Determined by data saturation, with an estimated minimum of 30 participants based on qualitative research norms.  

Inclusion Criteria:
- Parents of typically developing children aged 5–7 years.  
- Participants residing in Mumbai suburban areas for at least five years.  
- Parents from nuclear and joint families of diverse ethnicities and socio-economic statuses.  

Exclusion Criteria:
- Parents unwilling to participate.  
- Children with congenital anomalies.  


Data Collection Procedure

Permissions: 
Approval from the Institutional Ethics Committee (IEC) is required. Written consent will be obtained from all participants.  

Recruitment:
Participants will be recruited from schools near KEM Hospital.  

Process:
1. Sociodemographic Data:Collect personal information of participants.  
2. Semi-Structured Interviews: Conducted in participants’ homes using a pre-validated multilingual questionnaire (English, Marathi, or Hindi).  
3. Recording: Audio recordings of interviews, stored as transcripts with confidentiality maintained.  
4. Interview Content: Probing questions focusing on feeding practices, routines, cultural influences, and challenges.  

Questionnaire Themes

The pre-validated questionnaire addresses the following:  
1. Who handles feeding in the family?  
2. How are children involved in meal selection and preparation?  
3. Are there specific cultural rules or routines guiding feeding practices?  
4. Influence of traditional foods and beliefs on children’s eating habits.  
5. Balancing cultural traditions with modern dietary influences.  
6. Challenges in introducing new foods while respecting cultural norms.  
7. Observed changes in cultural feeding practices over time.  

Data Analysis

Saturation Point:Data collection stops when no new information emerges.  
Thematic Analysis:
  Line-by-line coding of interview transcripts to identify emerging concepts.  
 Similar concepts grouped into sub-themes, forming overarching themes.  
 Themes derived strictly from the data, avoiding preconceived notions.  

Review of Literature
The study builds on existing research exploring cultural and environmental factors influencing feeding practices across different ethnicities and socio-economic contexts. 

For example:  

- Hispanic parents’ feeding practices linked to cultural and environmental factors.  
- Food taboos in Benin affecting nutrient intake during pregnancy.  
- Brazilian immigrant mothers adapting feeding practices based on sociocultural changes.  

Significance of the Study

1. Understanding Cultural Nuances: Helps to identify how cultural variations influence feeding occupations.  
2. Developing Responsive Strategies: Occupational therapists can use insights to create culturally tailored interventions.  
3. Promoting Healthy Eating: Encourages positive feeding practices while respecting cultural traditions.  
4. Bridging Gaps in Literature: Addresses the lack of research on cultural feeding practices in India.  

Ethical Considerations

- Participants’ identities and responses will remain confidential.  
- Voluntary participation with the option to withdraw at any time.  
- No financial compensation offered.  
- Findings may be published without revealing participants’ identities.  


Expected Outcomes
This study aims to provide a deeper understanding of how cultural diversity shapes feeding occupations. The findings will support professionals in developing culturally responsive interventions to improve children’s health and well-being.
 
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