Diaper Distribution in Low-Income Infants

A Pilot Randomized Controlled Trial of Diaper Distribution in Low-Income Infants

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.

Study Overview

• Status: Withdrawn
• Conditions: Stress; Depressive Symptoms; UTI; Diaper Rash
• Intervention / Treatment: Other: Diapers; Other: Resources of diaper banks

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 days to 9 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Receive 600 diapers.	Other: Diapers; Receive 600 diapers.
Active Comparator: Control Group; Receive resources of diaper banks as requested.	Other: Resources of diaper banks; Caregivers will receive resources of diaper banks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiver acceptability of receiving diapers	Qualitative interviews with caregivers to assess acceptability of intervention delivery from a clinic setting.	9 months
Rate of enrollment by eligible families	Proportion of caregivers enrolled and proportion of caregivers declined enrollment out of total number of eligible families approached.	9 months
Rate of declination of enrollment by eligible families	Proportion of caregivers declined enrollment out of total number of eligible families approached.	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of diaper dermatitis	Episodes of diaper dermatitis diagnosed by clinicians at Boston Medical Center during a well-child, urgent care, or emergency department visit.	9 months
Incidence of UTIs	Episodes of urinary tract infections diagnosed by urine culture during a well-child, urgent care, or emergency department visit at Boston Medical Center.	9 months
Attendance at planned well-child visits	Proportion of attended well-child visits; expected to have 4-5 visits over 9 months based on age of enrollment	9 months
Adherence to the immunization schedule	Received all required vaccines through 6 months of age according to the published CDC schedule by 7 months of age.	9 months
Change in caregiver well-being indices	The Parents' Assessment of Protective Factors Instrument is used to measure the presence and magnitude of self-reported beliefs and behaviors that are indicators of the Strengthening Families protective factors, which can be used to mitigate risk factors and actively enhance family well-being. The instrument contains 36 items with a total score (Protective Factors Strength Index) and subscale scores for parental resilience, social connections, concrete support in times of need, social emotional competence of children. PFSI scores and subscales can range from 0 to 4, higher scores are more favorable. The change in PFSI scores compared to baseline score and immediately prior score at each time point will be measured.	baseline, 2 months, 4 months, 6 months, and 9 months
Change in depressive symptoms of caregivers	Patient Health Questionnaire (PHQ 9) is a multipurpose instrument for screening, measuring, and monitoring depressive symptoms. It contains 9 questions with response options referenced to the past 2 weeks from 0 to 3 where 0=not at all, 1=several days, 2=more than half the days, 3=nearly every day. Scores can range form 0 to 27, lower scores are more favorable. The change in PHQ 9 scores compared to baseline score and immediately prior score at each time point will be measured.	baseline, 2 months, 4 months, 6 months, and 9 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survey completion time	Average time in minutes to complete surveys	9 months

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: Health Resources and Services Administration (HRSA)
• Investigators: Principal Investigator: Hong-An Nguyen, MD, Boston Medical Center; Principal Investigator: Caroline Kistin, MD, Boston Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2018
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): January 1, 2019

Study Registration Dates

• First Submitted: January 26, 2018
• First Submitted That Met QC Criteria: February 1, 2018
• First Posted (Actual): February 8, 2018

Study Record Updates

• Last Update Posted (Actual): April 12, 2018
• Last Update Submitted That Met QC Criteria: April 10, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Infants; Caregiver stress; Diaper need; Well baby visits; Low-income families
• Additional Relevant MeSH Terms: Behavioral Symptoms; Skin Diseases; Dermatitis; Skin Diseases, Eczematous; Dermatitis, Irritant; Dermatitis, Contact; Depression; Diaper Rash
• Other Study ID Numbers: H-37185; T32HP10028 (Other Grant/Funding Number: HRSA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No