NCT07146477

Brief Summary

The goal of this observational study is to examine how urban slum food environments influence caregivers' feeding practices for children under five years of age in Pune. The main questions it aims to answer are:

  • What are the characteristics of the food environment in selected slums of Pune using the 5 A's framework: availability, accessibility, affordability, acceptability, and accommodation?
  • What are caregivers' perceptions of food safety, food prestige, and convenience as additional drivers of food choice within the slum context?
  • Are caregivers' aware, and have understanding about the use of packaged food labels, especially in relation to identifying foods for young children?
  • How do the local food environment and food choice (FEFC) drivers interact to influence caregivers' feeding practices, with a particular focus on the consumption of unhealthy foods and sugar-sweetened beverages among children under five years of age? Participants will be interviewed using digital forms to assess their food environment and food choice drivers. Anthropometric measurements of all children under five years of age in the household will be taken.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
370

participants targeted

Target at P75+ for all trials

Timeline
14mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Sep 2025Jun 2027

First Submitted

Initial submission to the registry

August 16, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 28, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

September 29, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

September 24, 2025

Status Verified

September 1, 2025

Enrollment Period

9 months

First QC Date

August 16, 2025

Last Update Submit

September 19, 2025

Conditions

Keywords

Food Choice DriversFood EnvironmentUrban SlumsIndiaFamilyInfant Feeding

Outcome Measures

Primary Outcomes (7)

  • Percentage food items in each of the 28 food groups available in each of the 4 study locations

    Food Availability in each study location will be assessed as the percentage food items available for purchase in each of the 28 food groups. The Food Outlet Census (https://sites.rutgers.edu/food-environment-toolbox/community-food-environment-mapping-food-outlet-census/) tool is being used to collect data on the foods available but the tool does not have any specific scoring criteria.

    An average of 1 year

  • Percentage of families in each study location who can afford to buy a healthy diet

    Food Affordability of families will be assessed as the percentage of families who can afford a healthy diet. For this purpose then investigators will calculate Cost of a Healthy Diet (CoHD) using the tool available from Tufts University: https://sites.tufts.edu/foodpricesfornutrition/tools/. Per capita income of each household will also be calculated. These two parameters will help the investigators calculate the percentage of families in each location who can afford a healthy diet.

    An average of 1 Year

  • Percentage of food items considered convenient by households in each location

    Convenience will be assessed as percentage of food items in each of the 28 food groups which participants consider convenient because their ease of storage, low perishability, ease of preparation.

    An average of 1 year

  • Gender and Family Role of the primary food-related decision maker

    The gender and family role of primary food-related decision maker will be assessed as percentages and illustrated using pie-charts

    An average of 1 year

  • Percentage of participants concerned with food safety

    Percentage of participants worried of safety of food due to poor hygiene or use of pesticides will be asessed

    An average of 1 year

  • Percentage of households with label awareness

    The percentage of households who were aware of food labeling (read labels, knew where the label was located) will be assessed

    An average of 1 year

  • Correlation of food environment characteristics with infant and young child feeding practices

    The correlation of different food environment characteristics such as accessibility, availability, affordability, with infant and young child feeding indicators such as ultra-processed food consumption, zero fruit and vegetable consumption

    An average of 1 year

Secondary Outcomes (2)

  • Number and types of food outlets in the study location

    An average of 1 year

  • Type of foods being promoted in the study locations

    An average of 1 year

Study Arms (2)

Family or Household

Family or Households (n = 250) include all the members residing in one house sharing food and other amenities and who have children under 5 years of age.

Food Vendors

Food Vendors (n = 120) who operate in the 500 m radius of the household cluster will be interviewed in depth to characterize the type of foods sold so that the food environment of the family can be characterized.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

1. The study population will consist of Infant and young child caregivers living in slums who have a child or children less than five years of age and had enrolled in an earlier study to assess utilization of maternal healthcare services in these slums. 2. Food vendors (stores, mobile informal vendors and hawkers, and restaurants) who function in the 500 m radius of the household.

You may qualify if:

  • For Family Units:
  • Families who had participated in the previous house-to-house survey to determine maternal healthcare utilization and infant and young child feeding practices.
  • Families where all the female caregivers are willing to participate.
  • For Food Vendors:
  • Food vendors who regularly carry out business in the 500 m radius of the household.
  • Willingness to participate in the study.

You may not qualify if:

  • \. Families who were a part of the earlier project but have moved out of the survey area.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hirabai Cowasji Jehangir Medical Research Institute

Pune, Maharashtra, 411001, India

Location

Central Study Contacts

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director

Study Record Dates

First Submitted

August 16, 2025

First Posted

August 28, 2025

Study Start

September 29, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2027

Last Updated

September 24, 2025

Record last verified: 2025-09

Locations