Intervention to Reduce Diaper Need and Increase Use of Pediatric Preventive Care

NCT03490045 | Completed

• 1 other identifier: 2000023616
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 2

Brief Summary

Well-child care is the primary source of preventative health care for children. These visits provide an opportunity for physicians to assess an infant's biomedical health, development, and behavior, as well as help ensure timely immunizations, reduce the use of acute care services, and assess and family functioning. Yet, disparities in the utilization of pediatric care exist by race, ethnicity and income in the U.S., even despite high rates of overall access to primary care. Incentives have been proposed as one way to increase utilization of preventative care for mothers and children. Diapering is another important form of preventative health care that can be particularly difficult for low-income parents due the cost of diapers, which is $70-80 per child per month, or approximately $960 per year, on average. And government programs, such as Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), Supplemental Nutrition Assistance Program (SNAP), and Temporary Assistance for Needy Families (TANF), either cannot be used to purchase diapers, or do not provide enough assistance to cover the cost of diapers and other basic needs. A family's inability to provide an adequate supply of diapers for their child is called diaper need. Nationwide, one in three families with young children report experiencing diaper need, which was found to be significantly associated with maternal stress and depression, which in turn, can have a detrimental impact on a family's health and economic success. The primary goal of this study is to conduct a randomized controlled trial of a diaper provision intervention designed to increase utilization of, and adherence to, well-child visits and reduce diaper need among low-resourced families in New Haven, CT.

Conditions

Diaper Dermatitis; Urinary Tract Infections; Infection; Depressive Symptoms; Stress

Keywords

Diaper Need; Well-Child Care; Infant Immunizations; Incentives; Basic Needs

Outcome Measures

Primary Outcomes (4)

• Well-Child Visits

  The proportion of well-child visits attended.

  9 Months

• Diaper Need

  The proportion of families that report experiencing diaper need. Diaper need will be measured via self-report using a scale developed by Smith et al.(2013).

  9 Months

• Incidence of Diaper Dermatitis/Rash

  The number of episodes of diaper dermatitis/rash recorded by Yale New Haven Health physicians.

  9 Months

• Incidence of Urinary Tract Infections

  The number of episodes of urinary tract infections (UTIs) recorded by Yale New Haven Health physicians.

  9 Months

Secondary Outcomes (4)

• Depressive Symptoms Among Mothers

  9 Months

• Diaper-related Absences Among Mothers

  9 Months

• Stress

  9 Months

• Basic Need

  9 Months

Study Arms (2)

Intervention Condition

EXPERIMENTAL

Postpartum women and their infants will be randomly assigned to the treatment condition and receive a diaper incentive for their participation.

Other: Diaper Incentive

Comparison Condition

ACTIVE COMPARATOR

Postpartum women and their infants will be randomly assigned to the control condition and will receive a conditional cash transfer of equivalent value of the diapers provided to the intervention group.

Other: Conditional Cash Transfer Condition

Interventions

Diaper Incentive OTHER

A diaper incentive will be distributed to participants in the Intervention condition at 4-time points, which will coincide with the well-child visits that occur at 2-weeks, 2-months, 4-months, and 6-months. A follow-up assessment will also occur approximately 3 months after the family received their final distribution of diapers.

Intervention Condition

Conditional Cash Transfer Condition OTHER

Participants in the control condition will receive the cash equivalent value of the diapers distributed to the Experimental Condition for their participation at 4-time points, which will coincide with the well-child visits that occur at 2-weeks, 2-months, 4-months, and 6-months. A follow-up assessment will also occur approximately 3 months after the family received their final conditional cash transfer.

Comparison Condition

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postpartum women who receive care at Yale New Haven Health
• Are about to give birth or recently gave birth to a singleton infant who is 0 to 1-week old (index child)
• Have not received a distribution of diapers for the index child
• English- speaking

You may not qualify if:

• Infant admitted to the NICU during the baseline assessment time period
• Infant admitted to the hospital at assessment visits 1-4
• Infant is born with or develops a gastrointestinal condition or illness that will impact the health outcomes of the study

Sponsors & Collaborators

• Yale University: lead
• National Diaper Bank Network: collaborator
• Yale New Haven Health Primary Care Consortium: collaborator

Study Sites (2)

Center for Wellbeing of Women and Mothers, 40 Temple Street, Ste 6B, Yale University

New Haven, Connecticut, 06510, United States

Location

Yale School of Medicine

New Haven, Connecticut, 06510, United States

Location

Related Publications (1)

• Smith MV, Kruse A, Weir A, Goldblum J. Diaper need and its impact on child health. Pediatrics. 2013 Aug;132(2):253-9. doi: 10.1542/peds.2013-0597. Epub 2013 Jul 29.

  PMID: 23897910 BACKGROUND

Related Links

• Mental Health Outreach for MotherS Partnership

MeSH Terms

Conditions

Diaper Rash; Urinary Tract Infections; Infections; Depression

Condition Hierarchy (Ancestors)

Dermatitis, Irritant; Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: April 6, 2018
• Study Start: April 1, 2019
• Primary Completion: August 17, 2020
• Study Completion: August 17, 2020
• Last Updated: April 24, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)