NCT00304304

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Feb 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

February 17, 2016

Status Verified

February 1, 2016

Enrollment Period

10 months

First QC Date

March 16, 2006

Last Update Submit

February 14, 2016

Conditions

Asthma

Keywords

child care centersasthma triggerscommunity-based research

Outcome Measures

Primary Outcomes (1)

  • 6 month post-intervention: quality of CCC asthma policy

    Did CCC have appropriate policy

    6 months

Secondary Outcomes (1)

  • 6 month post-intervention changes in asthma outcomes

    6 months

Study Arms (2)

Intervention - asthma education

ACTIVE COMPARATOR

CCC received asthma education in the first 6 months of the study

Behavioral: Asthma education

Wait-list control

PLACEBO COMPARATOR

CCC received asthma education in second 6 months of study

Behavioral: Asthma education

Interventions

Asthma educationBEHAVIORAL

Research assistant worked with CCC staff on asthma prevention

Intervention - asthma educationWait-list control

Eligibility Criteria

Age1 Year - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami Mailman Center for Child Development

Miami, Florida, 33101, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Jeffrey P Brosco, MD PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Clinical Pediatrics

Study Record Dates

First Submitted

March 16, 2006

First Posted

March 17, 2006

Study Start

February 1, 2006

Primary Completion

December 1, 2006

Study Completion

June 1, 2007

Last Updated

February 17, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)