NCT06601439

Brief Summary

The goal of this observational study is to assess household food insecurity among slum-dwelling women in India and to explore if household food insecurity is associated with maternal healthcare services utilization and infant feeding practices The main questions it aims to answer are:

  1. 1.Is the utilization of maternal healthcare services antenatally, during delivery, and postnatally associated with household food insecurity among slum-dwelling women in Pune, India?
  2. 2.Is household food insecurity associated with birth outcomes and infant growth in these women?
  3. 3.For information related to socio-demographic characteristics, healthcare services utilization, food insecurity experience, dietary intake, and infant feeding indicators using a questionnaire.
  4. 4.Anthropometric measurements of the participant, her husband and her infant/s will be collected.
  5. 5.Focus group discussions (FGDs) will also be conducted to gain insight into the perceptions of these women with respect to the utilization of maternal healthcare services.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
3mo left

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress88%
Aug 2024Jul 2026

First Submitted

Initial submission to the registry

July 16, 2024

Completed
20 days until next milestone

Study Start

First participant enrolled

August 5, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2025

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Expected
Last Updated

August 24, 2025

Status Verified

August 1, 2025

Enrollment Period

7 months

First QC Date

July 16, 2024

Last Update Submit

August 22, 2025

Conditions

Outcome Measures

Primary Outcomes (9)

  • Percentage of women who consumed at least 100 Iron Folic Acid tablets

    Percentage of women who consumed at least 100 Iron Folic Acid tablets

    Through study completion, an average of 1 year

  • Percentage of women who consumed deworming tablets at least once during pregnancy

    Percentage of women who consumed deworming tablets at least once during pregnancy

    Through study completion, an average of 1 year

  • Percentage of women who underwent delivery preparedness

    Percentage of women who underwent delivery preparedness

    Through study completion, an average of 1 year

  • Percentage of women with knowledge of key danger signs during pregnancy

    Percentage of women with knowledge of key danger signs during pregnancy such as vaginal bleeding, severe headaches

    Through study completion, an average of 1 year

  • Percentage of women who delivered at institution

    Percentage of women who delivered at institution

    Through study completion, an average of 1 year

  • Percentage of women who stayed at a facility for at least 24 hours post-delivery

    Percentage of women who stayed at a facility for at least 24 hours post-delivery

    Through study completion, an average of 1 year

  • Percentage of women who received post-natal care within a week of delivery

    Percentage of women who received post-natal care within a week of delivery

    Through study completion, an average of 1 year

  • Percentage of women who availed at least three Antenatal Care (ANC) visits

    Percentage of women who availed at least three Antenatal Care (ANC) visits

    Through study completion, an average of 1 year

  • Percentage of women who had contact with ASHA worker during pregnancy

    Percentage of women who had contact with Accredited Social Health Activist (ASHA) worker during pregnancy

    Through study completion, an average of 1 year

Secondary Outcomes (1)

  • Association of demographic characteristics and household food insecurity scores with the indicators of utilization of healthcare services

    Through study completion, an average of 1 year

Other Outcomes (2)

  • Correlation of indicators of utilization of healthcare services with birth outcomes

    Through study completion, an average of 1 year

  • Correlation of indicators of utilization of healthcare services with infant growth

    Through study completion, an average of 1 year

Interventions

Observational Study

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe study deals with assessment of utilization of maternal healthcare services
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Subjects will be recruited by house-to-house survey in two major slums currently serviced by the Research Institute in Pune city

You may qualify if:

  • is willing and able to give informed consent
  • has been residing in a slum for a minimum of 3 years
  • is aged between 18 to 49 years
  • has a child or children less than 2 years of age

You may not qualify if:

  • She is unwilling to consent to participate in the study
  • The age of her child or children is greater than 2 years.
  • The mother or child have any congenital / chronic conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hirabai Cowasji Jehangir Medical Research Institute

Pune, Maharashtra, 411001, India

Location

MeSH Terms

Conditions

Feeding Behavior

Interventions

Observation

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Rubina M Mandlik, PhD

    Hirabai Cowasji Jehangir Medical Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 16, 2024

First Posted

September 19, 2024

Study Start

August 5, 2024

Primary Completion

March 7, 2025

Study Completion (Estimated)

July 31, 2026

Last Updated

August 24, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations