NCT03425851

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 8, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

March 14, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

April 12, 2018

Status Verified

April 1, 2018

Enrollment Period

10 months

First QC Date

January 26, 2018

Last Update Submit

April 10, 2018

Conditions

Diaper RashUTIDepressive SymptomsStress

Keywords

Diaper needInfantsWell baby visitsLow-income familiesCaregiver stress

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (6)

  • Incidence of diaper dermatitis

    9 months

  • Incidence of UTIs

    9 months

  • Attendance at planned well-child visits

    9 months

  • Adherence to the immunization schedule

    9 months

  • Change in caregiver well-being indices

    baseline, 2 months, 4 months, 6 months, and 9 months

  • +1 more secondary outcomes

Other Outcomes (1)

  • Survey completion time

    9 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

Receive 600 diapers.

Other: Diapers

Control Group

ACTIVE COMPARATOR

Receive resources of diaper banks as requested.

Other: Resources of diaper banks

Interventions

DiapersOTHER

Receive 600 diapers.

Intervention Group
Resources of diaper banksOTHER

Caregivers will receive resources of diaper banks.

Control Group

Eligibility Criteria

Age2 Days - 9 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Diaper RashDepressionCaregiver Burden

Condition Hierarchy (Ancestors)

Dermatitis, IrritantDermatitis, ContactDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousBehavioral SymptomsBehaviorStress, Psychological

Study Officials

  • Hong-An Nguyen, MD

    Boston Medical Center

    PRINCIPAL INVESTIGATOR

  • Caroline Kistin, MD

    Boston Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fellow, Dept of Pediatrics

Study Record Dates

First Submitted

January 26, 2018

First Posted

February 8, 2018

Study Start

March 14, 2018

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

April 12, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)