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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01873755
Other study ID # 2012-443
Secondary ID 5K23HD065742
Status Completed
Phase N/A
First received
Last updated
Start date December 5, 2012
Est. completion date June 20, 2014

Study information

Verified date May 2023
Source Montefiore Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 208
Est. completion date June 20, 2014
Est. primary completion date May 28, 2014
Accepts healthy volunteers No
Gender All
Age group 7 Years to 12 Years
Eligibility Inclusion Criteria: - children with active asthma attending 2nd-4th grades in Bronx Exclusion Criteria: - other medical conditions preventing participation in physical activity

Study Design


Related Conditions & MeSH terms


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

Locations

Country Name City State
United States Children's Hospital at Montefiore, Albert Einstein College of Medicine Bronx New York

Sponsors (2)

Lead Sponsor Collaborator
Montefiore Medical Center Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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 — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other change in days with asthma symptoms days with asthma symptoms will be assessed by parental self-report baseline, 6, 9, 12 months
Primary change in physical activity levels physical activity levels will be measured with accelerometers baseline, 6, 9, 12 months follow-up
Secondary change in Body Mass Index BMI will be assessed by measuring height and weight of children baseline, 6, 9 and 12 months
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