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

May 29, 2023 updated by: Montefiore Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

208

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10467
        • Children's Hospital at Montefiore, Albert Einstein College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 12 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • other medical conditions preventing participation in physical activity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: asthma physical activity intervention
two schools will receive 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in physical activity levels
Time Frame: baseline, 6, 9, 12 months follow-up
physical activity levels will be measured with accelerometers
baseline, 6, 9, 12 months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in Body Mass Index
Time Frame: baseline, 6, 9 and 12 months
BMI will be assessed by measuring height and weight of children
baseline, 6, 9 and 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in days with asthma symptoms
Time Frame: baseline, 6, 9, 12 months
days with asthma symptoms will be assessed by parental self-report
baseline, 6, 9, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Collaborators

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

Investigators

  • Principal Investigator: Marina Reznik, MD, MS, Children's Hospital at Montefiore, Albert Einstein College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2012

Primary Completion (Actual)

May 28, 2014

Study Completion (Actual)

June 20, 2014

Study Registration Dates

First Submitted

June 4, 2013

First Submitted That Met QC Criteria

June 6, 2013

First Posted (Estimated)

June 10, 2013

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 29, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-443
  • 5K23HD065742 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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