Clinical trial NCT03490045: Intervention to Reduce Diaper Need and Increase Use of Pediatric Preventive Care
Official title: Examining the Impact of an Intervention to Reduce Diaper Need and Increase Use of Pediatric Preventive Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diaper Dermatitis
Urinary Tract Infections
Infection
Depressive Symptoms
Stress
Keywords: Diaper Need
Well-Child Care
Infant Immunizations
Incentives
Basic Needs
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Diaper Bank Network
name: Yale New Haven Health Primary Care Consortium
First posted: 2018-04-06
Enrollment: 77
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: The investigators will conduct a randomized controlled trial of a diaper incentive intervention whereby diapers will be used to achieve two separate but related aims.

First, diapers will be used as an incentive to increase utilization of, and adherence to, well-child visits, during the first year of a newborn's life. More specifically, postpartum women who receive care in the Yale New Haven Health System will be randomly assigned to receive a diaper incentive in conjunction with their attendance at regularly scheduled well-child visits, according to the American Academy of Pediatrics (AAP) recommended schedule during the first year of a child's life. Diapers will be provided at the completion of the 2- week, 2-month, 4- month and 6-month visits. A follow-up phone call assessment will also occur approximately 3 months after the family receives their final distribution of diapers or conditional cash transfer. Postpartum women randomly assigned to the control condition will receive the cash equivalent value of the diaper incentive for their participation at these same time points.

Second, diapers will be used to reduce the level of diaper need. This will be evaluated using a self-report diaper need survey that will be administered along with other surveys to women in the intervention and control conditions in accordance with the AAP well-child visit schedule. In addition to diaper need, the following domains will be assessed:

Depressive symptoms, perceived stress, maternal-child attachment, ability to meet basic needs, and demographic information including but not limited to race-ethnicity, mother's age, parity, marital status, education level, income, employment status, child(ren)'s sex, child(ren)'s age, health status, healthcare access, and use.

The investigators anticipate that this study will result in greater use of, and adherence to, the recommended schedule of pediatric well-child visits, as well as a greater reduction of diaper need among families in the intervention group. The investigators also anticipate that the reduction of diaper need will be associated with decreased parenting stress and improved diaper-related health among women and children, respectively, in the intervention group.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Well-Child Visits
timeFrame: 9 Months
measure: Diaper Need
timeFrame: 9 Months
measure: Incidence of Diaper Dermatitis/Rash
timeFrame: 9 Months
measure: Incidence of Urinary Tract Infections
timeFrame: 9 Months
Secondary outcomes:
measure: Depressive Symptoms Among Mothers
timeFrame: 9 Months
measure: Diaper-related Absences Among Mothers
timeFrame: 9 Months
measure: Stress
timeFrame: 9 Months
measure: Basic Need
timeFrame: 9 Months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Center for Wellbeing of Women and Mothers, 40 Temple Street, Ste 6B, Yale University
state: Connecticut
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
Study officials:
References:
citation: 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.