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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03490045
Recruitment Status : Recruiting
First Posted : April 6, 2018
Last Update Posted : March 27, 2020
Sponsor:
Collaborators:
Yale New Haven Hospital
National Diaper Bank Network
Information provided by (Responsible Party):
Yale University

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.


Condition or disease Intervention/treatment Phase
Diaper Dermatitis Urinary Tract Infections Infection Depressive Symptoms Stress Other: Diaper Incentive Other: Conditional Cash Transfer Condition Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Examining the Impact of an Intervention to Reduce Diaper Need and Increase Use of Pediatric Preventive Care
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Arm Intervention/treatment
Experimental: Intervention Condition
Postpartum women and their infants will be randomly assigned to the treatment condition and receive a diaper incentive for their participation.
Other: Diaper Incentive
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.

Active Comparator: Comparison Condition
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
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 Measures :
  1. Well-Child Visits [ Time Frame: 9 Months ]
    The proportion of well-child visits attended.

  2. Diaper Need [ Time Frame: 9 Months ]
    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).

  3. Incidence of Diaper Dermatitis/Rash [ Time Frame: 9 Months ]
    The number of episodes of diaper dermatitis/rash recorded by Yale New Haven Health physicians.

  4. Incidence of Urinary Tract Infections [ Time Frame: 9 Months ]
    The number of episodes of urinary tract infections (UTIs) recorded by Yale New Haven Health physicians.


Secondary Outcome Measures :
  1. Depressive Symptoms Among Mothers [ Time Frame: 9 Months ]
    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)

  2. Diaper-related Absences Among Mothers [ Time Frame: 9 Months ]
    The proportion of mothers who report a decrease in diaper-related absences from work or school.

  3. Stress [ Time Frame: 9 Months ]
    A change in general stress scores between baseline and each time point. Stress will be measured by the Perceived Stress Scale 4 (PSS-4)

  4. Basic Need [ Time Frame: 9 Months ]
    Difference in basic need as measured by the U.S. Department of Agriculture Household Food Security Scale (2-item version) and Investigator-developed questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490045


Contacts
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Contact: Megan R Smith, Dr.PH 203-764-8655 megan.smith@yale.edu
Contact: Ashley Clayton, MA 203-764-7621 ashley.clayton@yale.edu

Locations
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United States, Connecticut
Center for Wellbeing of Women and Mothers, 40 Temple Street, Ste 6B, Yale University Recruiting
New Haven, Connecticut, United States, 06510
Contact: Ashley Clayton, MA    203-764-7621    diaperstudy@yale.edu   
Principal Investigator: Megan V Smith, DrPH         
Yale School of Medicine Recruiting
New Haven, Connecticut, United States, 06510
Contact: Ashley Clayton, MA    203-764-7621    diaperstudy@yale.edu   
Principal Investigator: Megan V Smith, MPH, DrPH         
Sponsors and Collaborators
Yale University
Yale New Haven Hospital
National Diaper Bank Network

Additional Information:
Publications:
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03490045    
Other Study ID Numbers: 2000023616
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: March 27, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yale University:
Diaper Need
Well-Child Care
Infant Immunizations
Incentives
Basic Needs
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Dermatitis
Diaper Rash
Depression
Skin Diseases
Urologic Diseases
Behavioral Symptoms
Dermatitis, Irritant
Dermatitis, Contact
Skin Diseases, Eczematous