NCT01873755

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
208

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Dec 2012

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

December 5, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 10, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2014

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2014

Completed
Last Updated

May 31, 2023

Status Verified

May 1, 2023

Enrollment Period

1.5 years

First QC Date

June 4, 2013

Last Update Submit

May 29, 2023

Conditions

Keywords

asthmachildrenphysical activityschool

Outcome Measures

Primary Outcomes (1)

  • change in physical activity levels

    physical activity levels will be measured with accelerometers

    baseline, 6, 9, 12 months follow-up

Secondary Outcomes (1)

  • change in Body Mass Index

    baseline, 6, 9 and 12 months

Other Outcomes (1)

  • change in days with asthma symptoms

    baseline, 6, 9, 12 months

Study Arms (1)

asthma physical activity intervention

EXPERIMENTAL

two schools will receive intervention

Behavioral: asthma physical activity intervention

Interventions

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

asthma physical activity intervention

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • other medical conditions preventing participation in physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital at Montefiore, Albert Einstein College of Medicine

The Bronx, New York, 10467, United States

Location

Related Publications (10)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • Reznik M, Islamovic F, Halterman JS, Leu CS, Zhang J, Ozuah PO. Multicomponent intervention for schoolchildren with asthma: Pilot cluster randomized controlled trial. J Allergy Clin Immunol Glob. 2025 Jan 18;4(2):100418. doi: 10.1016/j.jacig.2025.100418. eCollection 2025 May.

  • 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.

MeSH Terms

Conditions

AsthmaMotor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Marina Reznik, MD, MS

    Children's Hospital at Montefiore, Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2013

First Posted

June 10, 2013

Study Start

December 5, 2012

Primary Completion

May 28, 2014

Study Completion

June 20, 2014

Last Updated

May 31, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations