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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
Conditions the study is for
Asthma, Obesity, ADHD
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

Other trials in United States

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.

Conditions
Asthma, Obesity, ADHD
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 groups in NCT00339027
Study groupRoleWhat they receive
Preschool childrenChildren 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.

  1. 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.

  1. First posted20 Jun 2006 (estimated)
  2. Study startMay 2004
  3. Primary completionMar 2005
  4. Study completionMar 2005

Resources

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)
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

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.

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