Diaper DermatitisNCT03490045
Intervention to Reduce Diaper Need and Increase Use of Pediatric Preventive Care
A study testing Diaper Incentive and Conditional Cash Transfer Condition in people with Diaper Dermatitis and Urinary Tract Infections, run by Yale University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diaper Dermatitis, Urinary Tract Infections, Infection
- What is being tested?
- Diaper Incentive and Conditional Cash Transfer Condition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2019to 17 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Center for Wellbeing of Women and Mothers, 40 Temple Street, Ste 6B, Yale University
New Haven, Connecticut, 06510
Yale School of Medicine
New Haven, Connecticut, 06510
About this study
Official title: Examining the Impact of an Intervention to Reduce Diaper Need and Increase Use of Pediatric Preventive Care
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.
Read the 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.
- Being tested
- Diaper Incentive, Conditional Cash Transfer Condition
- Keywords
- Diaper Need, Well-Child Care, Infant Immunizations, Incentives, Basic Needs
- Medical subject headings
- Diaper Rash, Urinary Tract Infections, Infections, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaper IncentiveOther
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.
Conditional Cash Transfer ConditionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Condition | Experimental | Postpartum women and their infants will be randomly assigned to the treatment condition and receive a diaper incentive for their participation. Receives: 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. Receives: Other: Conditional Cash Transfer Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Well-Child Visits
The proportion of well-child visits attended.
Measured: 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).
Measured: 9 Months
Incidence of Diaper Dermatitis/Rash
The number of episodes of diaper dermatitis/rash recorded by Yale New Haven Health physicians.
Measured: 9 Months
Incidence of Urinary Tract Infections
The number of episodes of urinary tract infections (UTIs) recorded by Yale New Haven Health physicians.
Measured: 9 Months
Secondary outcomes (4)
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)
Measured: 9 Months
Diaper-related Absences Among Mothers
The proportion of mothers who report a decrease in diaper-related absences from work or school.
Measured: 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)
Measured: 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
Measured: 9 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start1 Apr 2019
- Primary completion17 Aug 2020
- Study completion17 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diaper DermatitisStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Diaper Bank Network, Yale New Haven Health Primary Care Consortium
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03490045
- Sponsor's protocol ID
- 2000023616
- Status last verified
- Apr 2023
- First submitted
- 29 Mar 2018
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23897910
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Impact of an Intervention to Reduce Diaper Need and Increase Use of Pediatric Preventive Care
- ClinicalTrials.gov ID
- NCT03490045
- Acronym / sponsor ID
- 2000023616
- Keywords
- Diaper Need, Well-Child Care, Infant Immunizations, Incentives, Basic Needs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Diaper Bank Network, Yale New Haven Health Primary Care Consortium
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 17 Aug 2020 (actual)
- Study completion
- 17 Aug 2020 (actual)
- First posted
- 6 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Condition | Experimental | Other: Diaper IncentivePostpartum women and their infants will be randomly assigned to the treatment condition and receive a diaper incentive for their participation. |
| Comparison Condition | Active comparator | Other: Conditional Cash Transfer ConditionPostpartum 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diaper IncentiveA 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. | Other | Intervention Condition |
| Conditional Cash Transfer ConditionParticipants 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. | Other | Comparison Condition |
Primary outcome
Well-Child Visits
Time frame: 9 Months
The proportion of well-child visits attended.
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).
Incidence of Diaper Dermatitis/Rash
Time frame: 9 Months
The number of episodes of diaper dermatitis/rash recorded by Yale New Haven Health physicians.
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.
4 secondary outcomes
Depressive Symptoms Among Mothers
Time frame: 9 Months
Diaper-related Absences Among Mothers
Time frame: 9 Months
Stress
Time frame: 9 Months
Basic Need
Time frame: 9 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- Background: PubMed 23897910Smith 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.
- Mental Health Outreach for MotherS PartnershipLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diaper Incentive and Conditional Cash Transfer Condition in people with Diaper Dermatitis and Urinary Tract Infections, run by Yale University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Well-Child Visits (time frame: 9 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03490045, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2023.