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Completed

NCT Number: NCT01873755

Addressing Barriers to Physical Activity in Inner-City Schoolchildren With Asthma

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.

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Key information

Conditions

Asthma Behavior Bronchial Diseases Children Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Motor Activity Physical Activity Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

The Bronx, New York, 10467, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • other medical conditions preventing participation in physical activity

Treatment and study plan

asthma physical activity intervention

Behavioral

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

  1. change in physical activity levels

    Time frame: baseline, 6, 9, 12 months follow-up

    physical activity levels will be measured with accelerometers

Secondary outcomes

  1. change in Body Mass Index

    Time frame: baseline, 6, 9 and 12 months

    BMI will be assessed by measuring height and weight of children

Other outcomes

  1. change in days with asthma symptoms

    Time frame: baseline, 6, 9, 12 months

    days with asthma symptoms will be assessed by parental self-report

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 10, 2013
Registry last updated
May 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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