Diaper Distribution in Low-Income Infants

NCT ID: NCT03425851

Last Updated: 2018-04-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-14
• Study Completion Date: 2019-01-31

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.

Conditions

Diaper Rash; UTI; Depressive Symptoms; Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention Group

Receive 600 diapers.

Group Type: EXPERIMENTAL

Diapers

Intervention Type: OTHER

Receive 600 diapers.

Control Group

Receive resources of diaper banks as requested.

Group Type: ACTIVE_COMPARATOR

Resources of diaper banks

Intervention Type: OTHER

Caregivers will receive resources of diaper banks.

Interventions

Diapers

Receive 600 diapers.

Intervention Type: OTHER

Resources of diaper banks

Caregivers will receive resources of diaper banks.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 2 Days
• Maximum Eligible Age: 9 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Health Resources and Services Administration (HRSA)

FED

Sponsor Role: collaborator

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Hong-An Nguyen

Fellow, Dept of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hong-An Nguyen, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Caroline Kistin, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

Boston Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

T32HP10028

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H-37185

Identifier Type: -

Identifier Source: org_study_id