Intervention to Reduce Diaper Need and Increase Use of Pediatric Preventive Care
Primary Purpose
Diaper Dermatitis, Urinary Tract Infections, Infection
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diaper Incentive
Conditional Cash Transfer Condition
Sponsored by
About this trial
This is an interventional prevention trial for Diaper Dermatitis focused on measuring Diaper Need, Well-Child Care, Infant Immunizations, Incentives, Basic Needs
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
Sites / Locations
- Center for Wellbeing of Women and Mothers, 40 Temple Street, Ste 6B, Yale University
- Yale School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention Condition
Comparison Condition
Arm Description
Postpartum women and their infants will be randomly assigned to the treatment condition and receive a diaper incentive for their participation.
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.
Outcomes
Primary Outcome Measures
Well-Child Visits
The proportion of well-child visits attended.
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).
Incidence of Diaper Dermatitis/Rash
The number of episodes of diaper dermatitis/rash recorded by Yale New Haven Health physicians.
Incidence of Urinary Tract Infections
The number of episodes of urinary tract infections (UTIs) recorded by Yale New Haven Health physicians.
Secondary Outcome Measures
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)
Diaper-related Absences Among Mothers
The proportion of mothers who report a decrease in diaper-related absences from work or school.
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)
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
Full Information
NCT ID
NCT03490045
First Posted
March 29, 2018
Last Updated
April 20, 2023
Sponsor
Yale University
Collaborators
National Diaper Bank Network, Yale New Haven Health Primary Care Consortium
1. Study Identification
Unique Protocol Identification Number
NCT03490045
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
August 17, 2020 (Actual)
Study Completion Date
August 17, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Diaper Bank Network, Yale New Haven Health Primary Care Consortium
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diaper Dermatitis, Urinary Tract Infections, Infection, Depressive Symptoms, Stress
Keywords
Diaper Need, Well-Child Care, Infant Immunizations, Incentives, Basic Needs
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Condition
Arm Type
Experimental
Arm Description
Postpartum women and their infants will be randomly assigned to the treatment condition and receive a diaper incentive for their participation.
Arm Title
Comparison Condition
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Diaper Incentive
Intervention Description
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 Type
Other
Intervention Name(s)
Conditional Cash Transfer Condition
Intervention Description
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.
Primary Outcome Measure Information:
Title
Well-Child Visits
Description
The proportion of well-child visits attended.
Time Frame
9 Months
Title
Diaper Need
Description
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
Title
Incidence of Diaper Dermatitis/Rash
Description
The number of episodes of diaper dermatitis/rash recorded by Yale New Haven Health physicians.
Time Frame
9 Months
Title
Incidence of Urinary Tract Infections
Description
The number of episodes of urinary tract infections (UTIs) recorded by Yale New Haven Health physicians.
Time Frame
9 Months
Secondary Outcome Measure Information:
Title
Depressive Symptoms Among Mothers
Description
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
Title
Diaper-related Absences Among Mothers
Description
The proportion of mothers who report a decrease in diaper-related absences from work or school.
Time Frame
9 Months
Title
Stress
Description
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
Title
Basic Need
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Center for Wellbeing of Women and Mothers, 40 Temple Street, Ste 6B, Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23897910
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.
Results Reference
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Intervention to Reduce Diaper Need and Increase Use of Pediatric Preventive Care
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