This trial is active, not recruiting.

Conditions asthma, children, physical activity
Treatment asthma physical activity intervention
Sponsor Montefiore Medical Center
Collaborator Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Start date October 2012
End date August 2017
Trial size 250 participants
Trial identifier NCT01873755, 2012-443, 5K23HD065742


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose health services research
two schools will receive intervention
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 Outcomes

change in physical activity levels
time frame: baseline, 6, 9, 12 months follow-up

Secondary Outcomes

change in Body Mass Index
time frame: baseline, 6, 9 and 12 months

Eligibility Criteria

Male or female participants from 7 years up to 12 years old.

Inclusion Criteria: - children with active asthma attending 2nd-4th grades in Bronx Exclusion Criteria: - other medical conditions preventing participation in physical activity

Additional Information

Official title Addressing Barriers to Physical Activity in Inner-City Schoolchildren With Asthma
Principal investigator Marina Reznik, MD, MS
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Montefiore Medical Center.