Clinical trial NCT03425851: Diaper Distribution in Low-Income Infants
Official title: A Pilot Randomized Controlled Trial of Diaper Distribution in Low-Income Infants
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diaper Rash
UTI
Depressive Symptoms
Stress
Keywords: Diaper need
Infants
Well baby visits
Low-income families
Caregiver stress
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Health Resources and Services Administration (HRSA)
First posted: 2018-02-08
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 child's health and their caregiver's overall health.

Detailed description: Infants born at Boston Medical Center and their caregivers will be recruited at any scheduled visit at Boston Medical Center's 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 child's 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, race/ethnicity, 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.

Eligibility criteria: Inclusion Criteria:

* Infants born at Boston Medical Center and seen in BMC pediatric primary care clinic at any outpatient visit between birth and 2 months of age.
* Caregivers of enrolled infants, including parents and legal guardians.
* Plan to obtain pediatric primary care at BMC for nine months.
* Have public insurance or Medicaid as their primary source of health insurance.

Exclusion Criteria:

* Caregivers who are minors (under age 18).
* Infants in the foster care system.

Primary outcomes:
measure: Caregiver acceptability of receiving diapers
timeFrame: 9 months
measure: Rate of enrollment by eligible families
timeFrame: 9 months
measure: Rate of declination of enrollment by eligible families
timeFrame: 9 months
Secondary outcomes:
measure: Incidence of diaper dermatitis
timeFrame: 9 months
measure: Incidence of UTIs
timeFrame: 9 months
measure: Attendance at planned well-child visits
timeFrame: 9 months
measure: Adherence to the immunization schedule
timeFrame: 9 months
measure: Change in caregiver well-being indices
timeFrame: baseline, 2 months, 4 months, 6 months, and 9 months
measure: Change in depressive symptoms of caregivers
timeFrame: baseline, 2 months, 4 months, 6 months, and 9 months
Other outcomes:
measure: Survey completion time
timeFrame: 9 months
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Hong-An Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Medical Center
name: Caroline Kistin, MD
role: PRINCIPAL_INVESTIGATOR
References: