Ignite Creation Date:
2024-05-06 @ 11:03 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03425851
Status:
WITHDRAWN
Last Update Posted:
2018-04-12
First Post:
2018-01-26
Brief Title:
Diaper Distribution in Low-Income Infants
Sponsor:
Boston Medical Center
Organization:
Boston Medical Center
Study Overview
Official Title:
A Pilot Randomized Controlled Trial of Diaper Distribution in Low-Income Infants
Status:
WITHDRAWN
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administrative issues precluded conducting the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 childs health and their caregivers overall health
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 childs health and their caregivers overall health
Detailed Description:
Infants born at Boston Medical Center and their caregivers will be recruited at any scheduled visit at Boston Medical Centers primary care clinic between birth and 2 months of age Eligible caregivers will complete a baseline survey and provide consent for the study investigators to perform a prospective chart review The infant-caregiver pair will be randomized to the intervention group or the control group The intervention group will receive 600 diapers distributed in packs of 200 to the families at the conclusion of the 2 month 4 month and 6 month old well-child visits The control group will receive resources of diaper banks in the greater Boston area
Surveys
Baseline At the initial visit the survey will obtain baseline data from the childs caregiver on prior history of diaper need current employment and income government benefits and other material hardships The survey will also include the Protective Factors Strength Level and Patient Health Questionnaire PHQ-9 both validated measures The survey will take approximately 15-20 minutes to complete Baseline surveys will be completed in person
Follow-up At the 2 month 4 month 6 month and 9 month well-child visits as applicable based on age of enrollment all enrolled families will complete a survey repeating the measures of diaper need the Protective Factors Strength Level and PHQ-9 Additional questions will ask about episodes of diaper rashes and economic impact of diaper need Families in the intervention group will be asked about acceptability of the intervention at the conclusion of the study
Chart review After the completion of the 2 month 4 month 6 month and 9 month well-child visits study staff will review the medical record for attendance at planned well-child visits adherence to the immunization schedule number of urgent care and ED visits and incidence of diaper dermatitis and urinary tract infections requiring treatment Demographic information extracted will include sex raceethnicity and confirmation of insurance status
All survey and chart review data will be de-identified and entered into REDCap with a unique study identification number
Surveys
Baseline At the initial visit the survey will obtain baseline data from the childs caregiver on prior history of diaper need current employment and income government benefits and other material hardships The survey will also include the Protective Factors Strength Level and Patient Health Questionnaire PHQ-9 both validated measures The survey will take approximately 15-20 minutes to complete Baseline surveys will be completed in person
Follow-up At the 2 month 4 month 6 month and 9 month well-child visits as applicable based on age of enrollment all enrolled families will complete a survey repeating the measures of diaper need the Protective Factors Strength Level and PHQ-9 Additional questions will ask about episodes of diaper rashes and economic impact of diaper need Families in the intervention group will be asked about acceptability of the intervention at the conclusion of the study
Chart review After the completion of the 2 month 4 month 6 month and 9 month well-child visits study staff will review the medical record for attendance at planned well-child visits adherence to the immunization schedule number of urgent care and ED visits and incidence of diaper dermatitis and urinary tract infections requiring treatment Demographic information extracted will include sex raceethnicity and confirmation of insurance status
All survey and chart review data will be de-identified and entered into REDCap with a unique study identification number
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| T32HP10028 | OTHER_GRANT | HRSA | None |