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HealthSpark 2: Improving Asthma Care for Preschool Children

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ClinicalTrials.gov Identifier: NCT00304304
Recruitment Status : Completed
First Posted : March 17, 2006
Last Update Posted : February 17, 2016
Sponsor:
Collaborators:
Health Foundation of South Florida
Ounce of Prevention Fund
The Early Childhood Initiative Foundation
Information provided by (Responsible Party):
Jeffrey P. Brosco, University of Miami

Brief Summary:
From a previous community needs survey, we determined that asthma was a particular problem in our community-based research network of child care centers. This study will examine whether a moderate intervention can help these centers improve their "asthma-friendly" rating as per NHLBI guidelines. We will both center directors and parents to establish baseline data on child health and the "asthma-friendliness" of each center. We will use a wait-list control, with all centers eventually receiving the intervention.

Condition or disease Intervention/treatment Phase
Asthma Behavioral: Asthma education Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Community - Based Asthma Intervention in Subsidized Preschools
Study Start Date : February 2006
Actual Primary Completion Date : December 2006
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Intervention - asthma education
CCC received asthma education in the first 6 months of the study
Behavioral: Asthma education
Research assistant worked with CCC staff on asthma prevention
Placebo Comparator: Wait-list control
CCC received asthma education in second 6 months of study
Behavioral: Asthma education
Research assistant worked with CCC staff on asthma prevention



Primary Outcome Measures :
  1. 6 month post-intervention: quality of CCC asthma policy [ Time Frame: 6 months ]
    Did CCC have appropriate policy


Secondary Outcome Measures :
  1. 6 month post-intervention changes in asthma outcomes [ Time Frame: 6 months ]
    Parent-report of fewer asthma symptoms



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Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children ages 1 - 5 years, enrolled in one of the designated SPARK child care centers

Exclusion Criteria:

  • Children under the age of 1 year
  • Children whose parents do not want to participate
  • Children whose child care centers do not want to participate

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): NCT00304304


Locations
United States, Florida
University of Miami Mailman Center for Child Development
Miami, Florida, United States, 33101
Sponsors and Collaborators
University of Miami
Health Foundation of South Florida
Ounce of Prevention Fund
The Early Childhood Initiative Foundation
Investigators
Principal Investigator: Jeffrey P Brosco, MD PhD University of Miami

Responsible Party: Jeffrey P. Brosco, Professor, Clinical Pediatrics, University of Miami
ClinicalTrials.gov Identifier: NCT00304304     History of Changes
Other Study ID Numbers: 20057395
First Posted: March 17, 2006    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jeffrey P. Brosco, University of Miami:
child care centers
asthma triggers
community-based research

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases