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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

Tracking Information
First Submitted Date  ICMJE June 4, 2013
First Posted Date  ICMJE June 10, 2013
Last Update Posted Date August 14, 2019
Study Start Date  ICMJE December 2012
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2013)
change in physical activity levels [ Time Frame: baseline, 6, 9, 12 months follow-up ]
physical activity levels will be measured with accelerometers
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01873755 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2013)
change in Body Mass Index [ Time Frame: baseline, 6, 9 and 12 months ]
BMI will be assessed by measuring height and weight of children
Original Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2013)
change in Body Mass Index [ Time Frame: baseline, 6, 9 and 12 months ]
BMI will be assessed by measuring heeght and weight of children
Current Other Pre-specified Outcome Measures
 (submitted: June 6, 2013)
change in days with asthma symptoms [ Time Frame: baseline, 6, 9, 12 months ]
days with asthma symptoms will be assessed by parental self-report
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Addressing Barriers to Physical Activity in Inner-City Schoolchildren With Asthma
Official Title  ICMJE Addressing Barriers to Physical Activity in Inner-City Schoolchildren With Asthma
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Asthma
  • Children
  • Physical Activity
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: asthma physical activity intervention
two schools will receive intervention
Intervention: Behavioral: asthma physical activity intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 6, 2013)
250
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • other medical conditions preventing participation in physical activity
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01873755
Other Study ID Numbers  ICMJE 2012-443
5K23HD065742 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Marina Reznik, Montefiore Medical Center
Study Sponsor  ICMJE Montefiore Medical Center
Collaborators  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Principal Investigator: Marina Reznik, MD, MS Children's Hospital at Montefiore, Albert Einstein College of Medicine
PRS Account Montefiore Medical Center
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP