An interventional study of Diaper Incentive and Conditional Cash Transfer Condition in Diaper Dermatitis, Urinary Tract Infections and Infection, sponsored by Yale University. Completed at 2 sites in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-24.
Sponsored by Yale University · Not applicable, Interventional, and Prevention
Among 12 studies in Diaper Rash with a site in United States — 1 open to participants now, 1 under way, none of them phase 3. Diaper Rash · United States.
Among the 12 studies in Diaper Rash with a site in United States, this one is the only one that started in 2019, is one of 5 with no phase, and was the 8th registered.
38 studies on the registry are indexed under Diaper Rash; 4 are open to participants now.
This study's enrollment of 77 is below the median of 92 across 28 interventional studies indexed under Diaper Rash.
Browse Diaper Rash studies →1 of the 12 studies in Diaper Rash with a site in United States is open now, in 1 country. Each count lists the studies.
Of the 2 Diaper Rash studies recruiting now, 1 (50%) set no upper age limit and 1 (50%) stop at 75 or younger; 1 take children under 18; 0 take healthy volunteers.
This study: 18 Years and older · female · healthy volunteers too.
The full table on the hub →12 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 1 started in 2019.
Median enrollment 26 across the 9 interventional studies, 25 across the 3 observational. Of the 10 that completed or were terminated, 4 (40%) have results posted.
6 of 12 have an industry lead sponsor. The 10 most frequent:
Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.
Yale University has 1 study filed under Diaper Rash — fewer than ten, so there is no comparison to draw.
1 of the studies in Diaper Rash with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06958003TriHealth Inc.Neonatal Intensive Care Unit (NICU) Diaper Dermatitis: Prevention and Treatment With Airtime | 2027-07-21 |
Among the 12 studies in Diaper Rash with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Postpartum women and their infants will be randomly assigned to the treatment condition and receive a diaper incentive for their participation.
Other: Diaper Incentive
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
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.
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.
Well-Child Visits
The proportion of well-child visits attended.
Time frame: 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).
Time frame: 9 Months
Incidence of Diaper Dermatitis/Rash
The number of episodes of diaper dermatitis/rash recorded by Yale New Haven Health physicians.
Time frame: 9 Months
Incidence of Urinary Tract Infections
The number of episodes of urinary tract infections (UTIs) recorded by Yale New Haven Health physicians.
Time frame: 9 Months
Depressive Symptoms Among Mothers
A change in depressive symptom score between baseline and each time point. Depressive symptoms will be assessed using the Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: 9 Months
Diaper-related Absences Among Mothers
The proportion of mothers who report a decrease in diaper-related absences from work or school.
Time frame: 9 Months
Stress
A change in general stress scores between baseline and each time point. Stress will be measured by the Perceived Stress Scale 4 (PSS-4)
Time frame: 9 Months
Basic Need
Difference in basic need as measured by the U.S. Department of Agriculture Household Food Security Scale (2-item version) and Investigator-developed questionnaire
Time frame: 9 Months
Plan to share: No
Ran from Apr 2019 to primary completion in Aug 2020, 16 months.
Of 18 interventional studies with no phase under Diaper Rash, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 11. This study's 16 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.