Back to resultsAddressing Barriers to Physical Activity in Inner-City Schoolchildren With Asthma
Primary Purpose
Asthma, Children, Physical Activity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
asthma physical activity intervention
Sponsored by
About this trial
This is an interventional health services research trial for Asthma focused on measuring asthma, children, physical activity, school
Eligibility Criteria
Inclusion Criteria:
- children with active asthma attending 2nd-4th grades in Bronx
Exclusion Criteria:
- other medical conditions preventing participation in physical activity
Sites / Locations
- Children's Hospital at Montefiore, Albert Einstein College of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
asthma physical activity intervention
Arm Description
two schools will receive intervention
Outcomes
Primary Outcome Measures
change in physical activity levels
physical activity levels will be measured with accelerometers
Secondary Outcome Measures
change in Body Mass Index
BMI will be assessed by measuring height and weight of children
Full Information
NCT ID
NCT01873755
First Posted
June 4, 2013
Last Updated
May 29, 2023
Sponsor
Montefiore Medical Center
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT01873755
Brief Title
Addressing Barriers to Physical Activity in Inner-City Schoolchildren With Asthma
Official Title
Addressing Barriers to Physical Activity in Inner-City Schoolchildren With Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 5, 2012 (Actual)
Primary Completion Date
May 28, 2014 (Actual)
Study Completion Date
June 20, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Children, Physical Activity
Keywords
asthma, children, physical activity, school
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
208 (Actual)
8. Arms, Groups, and Interventions
Arm Title
asthma physical activity intervention
Arm Type
Experimental
Arm Description
two schools will receive intervention
Intervention Type
Behavioral
Intervention Name(s)
asthma physical activity intervention
Intervention Description
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 Measure Information:
Title
change in physical activity levels
Description
physical activity levels will be measured with accelerometers
Time Frame
baseline, 6, 9, 12 months follow-up
Secondary Outcome Measure Information:
Title
change in Body Mass Index
Description
BMI will be assessed by measuring height and weight of children
Time Frame
baseline, 6, 9 and 12 months
Other Pre-specified Outcome Measures:
Title
change in days with asthma symptoms
Description
days with asthma symptoms will be assessed by parental self-report
Time Frame
baseline, 6, 9, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
children with active asthma attending 2nd-4th grades in Bronx
Exclusion Criteria:
other medical conditions preventing participation in physical activity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marina Reznik, MD, MS
Organizational Affiliation
Children's Hospital at Montefiore, Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital at Montefiore, Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24796650
Citation
Walker TJ, Reznik M. In-school asthma management and physical activity: children's perspectives. J Asthma. 2014 Oct;51(8):808-13. doi: 10.3109/02770903.2014.920875. Epub 2014 May 14.
Results Reference
result
PubMed Identifier
25454012
Citation
Reznik M, Bauman LJ, Okelo SO, Halterman JS. Asthma identification and medication administration forms in New York City schools. Ann Allergy Asthma Immunol. 2015 Jan;114(1):67-68.e1. doi: 10.1016/j.anai.2014.10.006. Epub 2014 Oct 24. No abstract available.
Results Reference
result
PubMed Identifier
25729770
Citation
Jaramillo Y, Reznik M. Do United States' teachers know and adhere to the national guidelines on asthma management in the classroom? A systematic review. ScientificWorldJournal. 2015;2015:624828. doi: 10.1155/2015/624828. Epub 2015 Feb 2.
Results Reference
result
PubMed Identifier
29309846
Citation
Kornblit A, Cain A, Bauman LJ, Brown NM, Reznik M. Parental Perspectives of Barriers to Physical Activity in Urban Schoolchildren With Asthma. Acad Pediatr. 2018 Apr;18(3):310-316. doi: 10.1016/j.acap.2017.12.011. Epub 2018 Jan 5.
Results Reference
result
PubMed Identifier
29084455
Citation
Cain A, Reznik M. The Principal and Nurse Perspective on Gaps in Asthma Care and Barriers to Physical Activity in New York City Schools: A Qualitative Study. Health Educ Behav. 2018 Jun;45(3):410-422. doi: 10.1177/1090198117736351. Epub 2017 Oct 31.
Results Reference
result
PubMed Identifier
28696842
Citation
Reznik M, Islamovic F, Choi J, Leu CS, Rowlands AV. Factors associated with in-school physical activity among urban children with asthma. J Asthma. 2018 May;55(5):492-501. doi: 10.1080/02770903.2017.1340482. Epub 2017 Jul 21.
Results Reference
result
PubMed Identifier
27031532
Citation
Cain A, Reznik M. Asthma management in New York City schools: A classroom teacher perspective. J Asthma. 2016 Sep;53(7):744-50. doi: 10.3109/02770903.2015.1135946. Epub 2016 May 17.
Results Reference
result
PubMed Identifier
27013055
Citation
Reznik M, Halterman JS. School asthma policies and teachers' confidence and attitudes about their role in asthma management. Ann Allergy Asthma Immunol. 2016 May;116(5):473-5. doi: 10.1016/j.anai.2016.03.005. Epub 2016 Mar 22. No abstract available.
Results Reference
result
PubMed Identifier
31314614
Citation
Reznik M, Greenberg E, Cain A, Halterman JS, Ivanna Avalos M. Improving teacher comfort and self-efficacy in asthma management. J Asthma. 2020 Nov;57(11):1237-1243. doi: 10.1080/02770903.2019.1640732. Epub 2019 Jul 17.
Results Reference
derived
Learn more about this trial
Addressing Barriers to Physical Activity in Inner-City Schoolchildren With Asthma
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