AsthmaNCT00339027
HealthSpark: Health Access for Children in Federally-Subsidized Child Care
An observational study of Asthma and Obesity, run by University of Miami at 1 site in United States.
Trial summary
HealthSpark is a community-based research network of childcare centers designed to improve the health of children in Miami-Dade County. HealthSpark is the health component of SPARK (Supporting Partnerships to Assure Ready Kids), a community coalition led by the Early Childhood Initiative Foundation to improve school… Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- How many people
- 960 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Mar 2005
- Phase
- Observational
- 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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children aged 3-5 years who are enrolled in federally-subsidized early care and education centers in underserved communities in Miami-Dade County
Who may be able to join
- Children ages 3 - 5 years, enrolled in one of the designated SPARK child care centers
Who cannot join
- Children under the age of 3 years or over the age of 5 years
- Children whose parents do not want to participate
- Children whose child care centers do not want to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Mailman Center for Child Development
Miami, Florida, 33101
About this study
HealthSpark is a community-based research network of childcare centers designed to improve the health of children in Miami-Dade County. HealthSpark is the health component of SPARK (Supporting Partnerships to Assure Ready Kids), a community coalition led by the Early Childhood Initiative Foundation to improve school readiness in Allapattah/Model City and Homestead/Florida City, two underserved Miami-Dade County communities. The goal of HealthSpark I is to identify the health and healthcare needs of preschool children, then help translate evidence-based intervention into community programs.
Read the detailed description
Preschool children are at risk for developing health problems that affect school readiness and that lead to significant health conditions through adulthood. Several decades of research have demonstrated that early identification and intervention is the best approach to ensuring healthy, successful children and adults. Despite advancements in our understanding of child health, large gaps in services continue; especially for children in poverty and for ethnic/racial minorities. National data supports the persistence of health disparities among children.
In May 2004, the HealthSpark team began to collect data from the parents, child care center directors, and local pediatricians in the two targeted communities. The HealthSpark I sample included 681 assessments of parents with children ages three or four years old, 53 child care center directors, and 30 primary care pediatricians. The parent assessments were conducted in person at the child care center. Additionally, in September 2004 four focus groups were conducted in the three primary languages of the communities, English, Spanish, and Creole. A content analysis was done on these sessions to determine the most prominent issues in each location.
Prevalence rates for obesity (38.0%) and asthma (29.3%) among the children the team surveyed were well above the national averages (20% and 7.4%). Despite high rates of health problems, roughly 10% of families reported not being able to get medical care for their child when they needed it, compared to the national average of 1.7% and a state of Florida average of 3.0%. HealthSpark also discovered that 20.9% of children are not properly restrained in motor vehicles. This statistic raises particularly high concern due to the fact that motor vehicle accidents are a leading cause of death among children and proper restraint in a vehicle is one step towards overcoming this statistic.
Access to health care is especially important for children with special health care needs. Of the total population, 8.7% need or use more medical care, mental health, or educational services than the average child. While this is low in comparison to the national average (12.8%), it still accounts for a significant portion of the population and demonstrates the need to ensure all children have appropriate access to care. Even though the majority of the children HealthSpark surveyed had some form of health insurance, 11.3% did not have any. This number is higher than the national average (9.5%) and raises concern over why specific barriers to access healthcare have not been broken down. During focus group sessions, parents described what specific issues were preventing them from either accessing medical care or not getting their children enrolled in the proper insurance program; these problems varied by region. Families located in the Allapattah/Model City region have access to Jackson Memorial Hospital and clinics but described long waiting times before they were able to see a physician. In contrast, families in Homestead/Florida City had more prevalence of uninsured children and are limited by their lack of access to transportation. Few families have cars and many described having to walk several miles in order to use public transportation. Many parents are not satisfied with the quality of healthcare their children are receiving, especially for families in the Homestead/Florida City area. Among the 43 healthcare professionals who deliver most of the pediatric primary care in these communities, 42.9% are not board-certified and only 26.2% are members of the American Academy of Pediatrics.
In HealthSpark I, we discovered child health issues existed in large part because of the lack of care and resources families in Miami-Dade County are receiving. However, even if every family had access to a high quality pediatrician the health of children in these two areas would not immediately improve. Interventions with a high level of collaboration among child care centers, pediatricians, and health educators will be the first step to improving the health of children within these two communities. In HealthSpark II, the intent is to demonstrate that improved coordination and cooperation among professionals and families will improve child health. The resources already exist in each community. In the initial HealthSpark survey, a network of child care centers and pediatricians interested in improving the health environment of the children in their community were identified. The HealthSpark team plans on helping these professionals come together and form a relationship that will improve and address the health needs of families.
- Keywords
- child care centers, community based research, behavioral health, health literacy, unmet healthcare needs
- Medical subject headings
- Asthma, Obesity, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Preschool children | Children aged 3-5 years who are enrolled in federally-subsidized early care and education centers in underserved communities in Miami-Dade County |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health concerns of parents
Descriptive survey
Measured: Cross-sectional
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2006 (estimated)
- Study startMay 2004
- Primary completionMar 2005
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 960 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Health Foundation of South Florida, Ounce of Prevention Fund, The Early Childhood Initiative Foundation
- Responsible party
- Sponsor
- Investigators
- Jeffrey P Brosco, MD, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00339027
- Sponsor's protocol ID
- 20040116
- Status last verified
- Aug 2021
- First submitted
- 16 Jun 2006
- Last updated
- 11 Aug 2021
- 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 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HealthSpark: Health Access for Children in Federally-Subsidized Child Care
- ClinicalTrials.gov ID
- NCT00339027
- Acronym / sponsor ID
- 20040116
- Keywords
- child care centers, community based research, behavioral health, health literacy, unmet healthcare needs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 960 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Health Foundation of South Florida, Ounce of Prevention Fund, The Early Childhood Initiative Foundation
- Study start
- May 2004
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 20 Jun 2006 (estimated)
- 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.
HealthSpark is a community-based research network of childcare centers designed to improve the health of children in Miami-Dade County. HealthSpark is the health component of SPARK (Supporting Partnerships to Assure Ready Kids), a community coalition led by the Early Childhood Initiative Foundation to improve school readiness in Allapattah/Model City and Homestead/Florida City, two underserved Miami-Dade County communities. The goal of HealthSpark I is to identify the health and healthcare needs of preschool children, then help translate evidence-based intervention into community programs.
Detailed description
Preschool children are at risk for developing health problems that affect school readiness and that lead to significant health conditions through adulthood. Several decades of research have demonstrated that early identification and intervention is the best approach to ensuring healthy, successful children and adults. Despite advancements in our understanding of child health, large gaps in services continue; especially for children in poverty and for ethnic/racial minorities. National data supports the persistence of health disparities among children.
In May 2004, the HealthSpark team began to collect data from the parents, child care center directors, and local pediatricians in the two targeted communities. The HealthSpark I sample included 681 assessments of parents with children ages three or four years old, 53 child care center directors, and 30 primary care pediatricians. The parent assessments were conducted in person at the child care center. Additionally, in September 2004 four focus groups were conducted in the three primary languages of the communities, English, Spanish, and Creole. A content analysis was done on these sessions to determine the most prominent issues in each location.
Prevalence rates for obesity (38.0%) and asthma (29.3%) among the children the team surveyed were well above the national averages (20% and 7.4%). Despite high rates of health problems, roughly 10% of families reported not being able to get medical care for their child when they needed it, compared to the national average of 1.7% and a state of Florida average of 3.0%. HealthSpark also discovered that 20.9% of children are not properly restrained in motor vehicles. This statistic raises particularly high concern due to the fact that motor vehicle accidents are a leading cause of death among children and proper restraint in a vehicle is one step towards overcoming this statistic.
Access to health care is especially important for children with special health care needs. Of the total population, 8.7% need or use more medical care, mental health, or educational services than the average child. While this is low in comparison to the national average (12.8%), it still accounts for a significant portion of the population and demonstrates the need to ensure all children have appropriate access to care. Even though the majority of the children HealthSpark surveyed had some form of health insurance, 11.3% did not have any. This number is higher than the national average (9.5%) and raises concern over why specific barriers to access healthcare have not been broken down. During focus group sessions, parents described what specific issues were preventing them from either accessing medical care or not getting their children enrolled in the proper insurance program; these problems varied by region. Families located in the Allapattah/Model City region have access to Jackson Memorial Hospital and clinics but described long waiting times before they were able to see a physician. In contrast, families in Homestead/Florida City had more prevalence of uninsured children and are limited by their lack of access to transportation. Few families have cars and many described having to walk several miles in order to use public transportation. Many parents are not satisfied with the quality of healthcare their children are receiving, especially for families in the Homestead/Florida City area. Among the 43 healthcare professionals who deliver most of the pediatric primary care in these communities, 42.9% are not board-certified and only 26.2% are members of the American Academy of Pediatrics.
In HealthSpark I, we discovered child health issues existed in large part because of the lack of care and resources families in Miami-Dade County are receiving. However, even if every family had access to a high quality pediatrician the health of children in these two areas would not immediately improve. Interventions with a high level of collaboration among child care centers, pediatricians, and health educators will be the first step to improving the health of children within these two communities. In HealthSpark II, the intent is to demonstrate that improved coordination and cooperation among professionals and families will improve child health. The resources already exist in each community. In the initial HealthSpark survey, a network of child care centers and pediatricians interested in improving the health environment of the children in their community were identified. The HealthSpark team plans on helping these professionals come together and form a relationship that will improve and address the health needs of families.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preschool children | – | –Children aged 3-5 years who are enrolled in federally-subsidized early care and education centers in underserved communities in Miami-Dade County |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged 3-5 years who are enrolled in federally-subsidized early care and education centers in underserved communities in Miami-Dade County
Key inclusion criteria (1 listed)
- Children ages 3 - 5 years, enrolled in one of the designated SPARK child care centers
Key exclusion criteria (3 listed)
- Children under the age of 3 years or over the age of 5 years
- Children whose parents do not want to participate
- Children whose child care centers do not want to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Health concerns of parents
Time frame: Cross-sectional
Descriptive survey
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 11 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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.
Jeffrey P Brosco, MD, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Obesity, run by University of Miami 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 1 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 11 Aug 2021. 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 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?
Health concerns of parents (time frame: Cross-sectional). 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 11 Aug 2021.