Diaper Distribution in Low-Income Infants
NCT03425851 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2018-04-12
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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