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Addressing Barriers to Physical Activity in Inner-City Schoolchildren With Asthma

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ClinicalTrials.gov Identifier: NCT01873755
Recruitment Status : Active, not recruiting
First Posted : June 10, 2013
Last Update Posted : August 14, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Marina Reznik, Montefiore Medical Center

Brief Summary:
This proposal will address the existent gaps in the literature by identifying barriers and facilitators to participation in physical activity in inner-city minority elementary schoolchildren with asthma, more that half of whom are also overweight; developing and refining a school-based intervention in partnership with the community to improve physical activity; and conducting a pilot randomized controlled trial of the intervention to determine feasibility and obtain preliminary data for a future large-scale trial.

Condition or disease Intervention/treatment Phase
Asthma Children Physical Activity Behavioral: asthma physical activity intervention Not Applicable

Detailed Description:
Four schools have been recruited for pilot wait-listed cluster randomized clinical trial to determine feasibility for a large-scaled trial. Community-based participatory research approach was utilized to develop an intervention that will be delivered to two schools. Two control schools will receive intervention during year 2 of the study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Addressing Barriers to Physical Activity in Inner-City Schoolchildren With Asthma
Study Start Date : December 2012
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: asthma physical activity intervention
two schools will receive intervention
Behavioral: asthma physical activity intervention
School- and community-based intervention includes several components: a classroom-based physical activity program, asthma awareness week at the school, asthma education for parents and students enrolled in the study, collaboration with child's physician to ensure proper medical treatment of child's asthma asthma education for school personnel




Primary Outcome Measures :
  1. change in physical activity levels [ Time Frame: baseline, 6, 9, 12 months follow-up ]
    physical activity levels will be measured with accelerometers


Secondary Outcome Measures :
  1. change in Body Mass Index [ Time Frame: baseline, 6, 9 and 12 months ]
    BMI will be assessed by measuring height and weight of children


Other Outcome Measures:
  1. change in days with asthma symptoms [ Time Frame: baseline, 6, 9, 12 months ]
    days with asthma symptoms will be assessed by parental self-report



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Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children with active asthma attending 2nd-4th grades in Bronx

Exclusion Criteria:

  • other medical conditions preventing participation in physical activity

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): NCT01873755


Locations
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United States, New York
Children's Hospital at Montefiore, Albert Einstein College of Medicine
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Marina Reznik, MD, MS Children's Hospital at Montefiore, Albert Einstein College of Medicine

Publications of Results:

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Responsible Party: Marina Reznik, PI, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01873755     History of Changes
Other Study ID Numbers: 2012-443
5K23HD065742 ( U.S. NIH Grant/Contract )
First Posted: June 10, 2013    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Marina Reznik, Montefiore Medical Center:
asthma
children
physical activity
school

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