Diaper Distribution in Low-Income Infants

NCT03425851 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-04-12

No results posted yet for this study

Summary

The adverse effects of poverty at the individual, family, and community level on health outcomes for children are well-established. Material hardship, defined as difficulty meeting basic needs such as food, housing, and consumer goods, has been shown to have negative physical and emotional effects on both children and their parents. Diaper need, defined as a lack of sufficient supply of clean and dry diapers, is an example of a material hardship.

Community-based studies of low-income families have demonstrated that between 30-50% of caregivers of young children expressed diaper need. Some of these caregivers with diaper need reported reducing diaper changes, a practice that is associated with diaper dermatitis and urinary tract infections (UTIs). These community-based studies have also shown that diaper need is associated with maternal depression and parental stress, even after adjusting for demographic factors and food insecurity. Diaper need may be a specific modifiable marker of caregiver stress and depression, beyond its role as an indicator of poverty. In this pilot, randomized controlled trial of low-income newborns and their caregivers the investigators will test the feasibility of supplying diapers as an intervention to infants in low-income families and assess if it can improve both a child's health and their caregiver's overall health.

Conditions

  • Diaper Rash
  • UTI
  • Depressive Symptoms
  • Stress

Interventions

OTHER

Diapers

Receive 600 diapers.

OTHER

Resources of diaper banks

Caregivers will receive resources of diaper banks.

Sponsors & Collaborators

  • Health Resources and Services Administration (HRSA)

    collaborator FED
  • Boston Medical Center

    lead OTHER

Principal Investigators

  • Hong-An Nguyen, MD · Boston Medical Center

  • Caroline Kistin, MD · Boston Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Days
Max Age
9 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-14
Primary Completion
2019-01-31
Completion
2019-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03425851 on ClinicalTrials.gov