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HealthSpark 2: Improving Asthma Care for Preschool Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00304304
First Posted: March 17, 2006
Last Update Posted: February 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  Purpose
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 Intervention
Asthma Behavioral: Asthma education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Community - Based Asthma Intervention in Subsidized Preschools

Further study details as provided by Jeffrey P. Brosco, University of Miami:

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


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


Enrollment: 2000
Study Start Date: February 2006
Study Completion Date: June 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

Responsible Party: Jeffrey P. Brosco, Professor, Clinical Pediatrics, University of Miami
ClinicalTrials.gov Identifier: NCT00304304     History of Changes
Other Study ID Numbers: 20057395
First Submitted: March 16, 2006
First Posted: March 17, 2006
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