Diaper RashNCT03425851
Diaper Distribution in Low-Income Infants
A study testing Diapers and Resources of diaper banks in people with Diaper Rash and UTI, run by Boston Medical Center at 1 site in United States.
Trial summary
The adverse effects of poverty at the individual, family, and community level on health outcomes for children are well-established. Material hardship, defined as difficulty meeting basic needs such as food, housing, and consumer goods, has been shown to have negative physical and emotional effects on both children and… Read more about this study
- Who is it for?
- Ages 2 days to 9 months
- Conditions the study is for
- Diaper Rash, UTI, Depressive Symptoms
- What is being tested?
- Diapers and Resources of diaper banks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2018to Jan 2019
- 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 2 days to 9 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants born at Boston Medical Center and seen in BMC pediatric primary care clinic at any outpatient visit between birth and 2 months of age.
- Caregivers of enrolled infants, including parents and legal guardians.
- Plan to obtain pediatric primary care at BMC for nine months.
- Have public insurance or Medicaid as their primary source of health insurance.
Who cannot join
- Caregivers who are minors (under age 18).
- Infants in the foster care system.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Randomized Controlled Trial of Diaper Distribution in Low-Income Infants
The adverse effects of poverty at the individual, family, and community level on health outcomes for children are well-established. Material hardship, defined as difficulty meeting basic needs such as food, housing, and consumer goods, has been shown to have negative physical and emotional effects on both children and their parents. Diaper need, defined as a lack of sufficient supply of clean and dry diapers, is an example of a material hardship.
Community-based studies of low-income families have demonstrated that between 30-50% of caregivers of young children expressed diaper need. Some of these caregivers with diaper need reported reducing diaper changes, a practice that is associated with diaper dermatitis and urinary tract infections (UTIs). These community-based studies have also shown that diaper need is associated with maternal depression and parental stress, even after adjusting for demographic factors and food insecurity. Diaper need may be a specific modifiable marker of caregiver stress and depression, beyond its role as an indicator of poverty. In this pilot, randomized controlled trial of low-income newborns and their caregivers the investigators will test the feasibility of supplying diapers as an intervention to infants in low-income families and assess if it can improve both a child's health and their caregiver's overall health.
Read the detailed description
Infants born at Boston Medical Center and their caregivers will be recruited at any scheduled visit at Boston Medical Center's primary care clinic between birth and 2 months of age. Eligible caregivers will complete a baseline survey and provide consent for the study investigators to perform a prospective chart review. The infant-caregiver pair will be randomized to the intervention group or the control group. The intervention group will receive 600 diapers, distributed in packs of 200 to the families at the conclusion of the 2 month, 4 month, and 6 month old well-child visits. The control group will receive resources of diaper banks in the greater Boston area.
Surveys:
- Baseline: At the initial visit, the survey will obtain baseline data from the child's caregiver on prior history of diaper need, current employment and income, government benefits, and other material hardships. The survey will also include the Protective Factors Strength Level and Patient Health Questionnaire (PHQ-9), both validated measures. The survey will take approximately 15-20 minutes to complete. Baseline surveys will be completed in person.
- Follow-up: At the 2 month, 4 month, 6 month, and 9 month well-child visits (as applicable based on age of enrollment), all enrolled families will complete a survey repeating the measures of diaper need, the Protective Factors Strength Level, and PHQ-9. Additional questions will ask about episodes of diaper rashes and economic impact of diaper need. Families in the intervention group will be asked about acceptability of the intervention at the conclusion of the study.
Chart review: After the completion of the 2 month, 4 month, 6 month, and 9 month well-child visits, study staff will review the medical record for attendance at planned well-child visits, adherence to the immunization schedule, number of urgent care and ED visits, and incidence of diaper dermatitis and urinary tract infections requiring treatment. Demographic information extracted will include sex, race/ethnicity, and confirmation of insurance status.
All survey and chart review data will be de-identified and entered into REDCap with a unique study identification number.
- Conditions
- Diaper Rash, UTI, Depressive Symptoms, Stress
- Being tested
- Diapers, Resources of diaper banks
- Keywords
- Diaper need, Infants, Well baby visits, Low-income families, Caregiver stress
- Medical subject headings
- Diaper Rash, Depression, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiapersOther
Receive 600 diapers.
Resources of diaper banksOther
Caregivers will receive resources of diaper banks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Receive 600 diapers. Receives: Other: Diapers |
| Control Group | Active comparator | Receive resources of diaper banks as requested. Receives: Other: Resources of diaper banks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver acceptability of receiving diapers
Qualitative interviews with caregivers to assess acceptability of intervention delivery from a clinic setting.
Measured: 9 months
Rate of enrollment by eligible families
Proportion of caregivers enrolled and proportion of caregivers declined enrollment out of total number of eligible families approached.
Measured: 9 months
Rate of declination of enrollment by eligible families
Proportion of caregivers declined enrollment out of total number of eligible families approached.
Measured: 9 months
Secondary outcomes (6)
Incidence of diaper dermatitis
Episodes of diaper dermatitis diagnosed by clinicians at Boston Medical Center during a well-child, urgent care, or emergency department visit.
Measured: 9 months
Incidence of UTIs
Episodes of urinary tract infections diagnosed by urine culture during a well-child, urgent care, or emergency department visit at Boston Medical Center.
Measured: 9 months
Attendance at planned well-child visits
Proportion of attended well-child visits; expected to have 4-5 visits over 9 months based on age of enrollment
Measured: 9 months
Adherence to the immunization schedule
Received all required vaccines through 6 months of age according to the published CDC schedule by 7 months of age.
Measured: 9 months
Change in caregiver well-being indices
The Parents' Assessment of Protective Factors Instrument is used to measure the presence and magnitude of self-reported beliefs and behaviors that are indicators of the Strengthening Families protective factors, which can be used to mitigate risk factors and actively enhance family well-being. The instrument contains 36 items with a total score (Protective Factors Strength Index) and subscale scores for parental resilience, social connections, concrete support in times of need, social emotional competence of children. PFSI scores and subscales can range from 0 to 4, higher scores are more favorable.
The change in PFSI scores compared to baseline score and immediately prior score at each time point will be measured.
Measured: baseline, 2 months, 4 months, 6 months, and 9 months
Change in depressive symptoms of caregivers
Patient Health Questionnaire (PHQ 9) is a multipurpose instrument for screening, measuring, and monitoring depressive symptoms. It contains 9 questions with response options referenced to the past 2 weeks from 0 to 3 where 0=not at all, 1=several days, 2=more than half the days, 3=nearly every day. Scores can range form 0 to 27, lower scores are more favorable.
The change in PHQ 9 scores compared to baseline score and immediately prior score at each time point will be measured.
Measured: baseline, 2 months, 4 months, 6 months, and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start14 Mar 2018
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Why it stopped: Administrative issues precluded conducting the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaper RashStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Responsible party
- Principal investigator, Hong-An Nguyen, Boston Medical Center
- Investigators
- Hong-An Nguyen, MD, Principal investigator, Boston Medical CenterCaroline Kistin, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425851
- Sponsor's protocol ID
- H-37185
- Other IDs
- T32HP10028
- Status last verified
- Apr 2018
- First submitted
- 26 Jan 2018
- Last updated
- 12 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial of Diaper Distribution in Low-Income Infants
- ClinicalTrials.gov ID
- NCT03425851
- Acronym / sponsor ID
- H-37185
- Conditions
- Diaper Rash, UTI, Depressive Symptoms, Stress
- Keywords
- Diaper need, Infants, Well baby visits, Low-income families, Caregiver stress
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Administrative issues precluded conducting the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Study start
- 14 Mar 2018 (actual)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 8 Feb 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.
The adverse effects of poverty at the individual, family, and community level on health outcomes for children are well-established. Material hardship, defined as difficulty meeting basic needs such as food, housing, and consumer goods, has been shown to have negative physical and emotional effects on both children and their parents. Diaper need, defined as a lack of sufficient supply of clean and dry diapers, is an example of a material hardship.
Community-based studies of low-income families have demonstrated that between 30-50% of caregivers of young children expressed diaper need. Some of these caregivers with diaper need reported reducing diaper changes, a practice that is associated with diaper dermatitis and urinary tract infections (UTIs). These community-based studies have also shown that diaper need is associated with maternal depression and parental stress, even after adjusting for demographic factors and food insecurity. Diaper need may be a specific modifiable marker of caregiver stress and depression, beyond its role as an indicator of poverty. In this pilot, randomized controlled trial of low-income newborns and their caregivers the investigators will test the feasibility of supplying diapers as an intervention to infants in low-income families and assess if it can improve both a child's health and their caregiver's overall health.
Detailed description
Infants born at Boston Medical Center and their caregivers will be recruited at any scheduled visit at Boston Medical Center's primary care clinic between birth and 2 months of age. Eligible caregivers will complete a baseline survey and provide consent for the study investigators to perform a prospective chart review. The infant-caregiver pair will be randomized to the intervention group or the control group. The intervention group will receive 600 diapers, distributed in packs of 200 to the families at the conclusion of the 2 month, 4 month, and 6 month old well-child visits. The control group will receive resources of diaper banks in the greater Boston area.
Surveys:
- Baseline: At the initial visit, the survey will obtain baseline data from the child's caregiver on prior history of diaper need, current employment and income, government benefits, and other material hardships. The survey will also include the Protective Factors Strength Level and Patient Health Questionnaire (PHQ-9), both validated measures. The survey will take approximately 15-20 minutes to complete. Baseline surveys will be completed in person.
- Follow-up: At the 2 month, 4 month, 6 month, and 9 month well-child visits (as applicable based on age of enrollment), all enrolled families will complete a survey repeating the measures of diaper need, the Protective Factors Strength Level, and PHQ-9. Additional questions will ask about episodes of diaper rashes and economic impact of diaper need. Families in the intervention group will be asked about acceptability of the intervention at the conclusion of the study.
Chart review: After the completion of the 2 month, 4 month, 6 month, and 9 month well-child visits, study staff will review the medical record for attendance at planned well-child visits, adherence to the immunization schedule, number of urgent care and ED visits, and incidence of diaper dermatitis and urinary tract infections requiring treatment. Demographic information extracted will include sex, race/ethnicity, and confirmation of insurance status.
All survey and chart review data will be de-identified and entered into REDCap with a unique study identification number.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: DiapersReceive 600 diapers. |
| Control Group | Active comparator | Other: Resources of diaper banksReceive resources of diaper banks as requested. |
Who may qualify
- Ages
- 2 days to 9 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants born at Boston Medical Center and seen in BMC pediatric primary care clinic at any outpatient visit between birth and 2 months of age.
- Caregivers of enrolled infants, including parents and legal guardians.
- Plan to obtain pediatric primary care at BMC for nine months.
- Have public insurance or Medicaid as their primary source of health insurance.
Key exclusion criteria (2 listed)
- Caregivers who are minors (under age 18).
- Infants in the foster care system.
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 |
|---|---|---|
| DiapersReceive 600 diapers. | Other | Intervention Group |
| Resources of diaper banksCaregivers will receive resources of diaper banks. | Other | Control Group |
Primary outcome
Caregiver acceptability of receiving diapers
Time frame: 9 months
Qualitative interviews with caregivers to assess acceptability of intervention delivery from a clinic setting.
Rate of enrollment by eligible families
Time frame: 9 months
Proportion of caregivers enrolled and proportion of caregivers declined enrollment out of total number of eligible families approached.
Rate of declination of enrollment by eligible families
Time frame: 9 months
Proportion of caregivers declined enrollment out of total number of eligible families approached.
6 secondary outcomes
Incidence of diaper dermatitis
Time frame: 9 months
Incidence of UTIs
Time frame: 9 months
Attendance at planned well-child visits
Time frame: 9 months
Adherence to the immunization schedule
Time frame: 9 months
Change in caregiver well-being indices
Time frame: baseline, 2 months, 4 months, 6 months, and 9 months
Change in depressive symptoms of caregivers
Time frame: baseline, 2 months, 4 months, 6 months, and 9 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
- Individual participant dataSharing planned: No
Related trials for Diaper Rash
Enrolling by invitation
Neonatal Intensive Care Unit (NICU) Diaper Dermatitis: Prevention and Treatment With Airtime
Diaper Dermatitis
Recruiting
Improving the Care of Incontinence-Associated Dermatitis (IAD) Using a Beta-Glucan Cream as a Hydrating and Soothing Agent
Fecal Incontinence, Urinary Incontinence
Not yet recruiting
Breast Milk Versus Barrier Creams for Diaper Dermatitis in Children Aged 0-24 Months
Diaper Dermatitis
Recruiting
Probiotics for Diaper Dermatitis
Diaper Dermatitis
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.
Hong-An Nguyen, MD principal investigator
Boston Medical Center
Caroline Kistin, MD principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diapers and Resources of diaper banks in people with Diaper Rash and UTI, run by Boston Medical Center at 1 site 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 2 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: withdrawn, as of the sponsor's last update on 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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?
Caregiver acceptability of receiving diapers (time frame: 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2018.