Brief Summary
Physical activity (PA) is an important component of asthma management in children. Studies show that PA is associated with decreased severity of asthma symptoms, as well as improved disease control and quality of life. However, urban minority children with asthma face barriers to PA on multiple levels.The goal of this research project is to evaluate whether a multifaceted school-based intervention that addresses key barriers to physical activity reduces asthma morbidity among urban schoolchildren with asthma.
Brief Title
Evaluation of the Asthma Management Program to Promote Activity for Students in Schools (Asthma-PASS)
Detailed Description
Investigators will conduct a cluster-randomized controlled trial with 416 children ages 5-11 years with persistent or uncontrolled asthma from 26 Bronx schools. Schools will be randomly assigned to either (1) the Asthma-PASS intervention or an asthma management (AM) comparison group. Both groups will participate in an existing classroom-based daily activity program. Enrollment will occur over 4 consecutive school years with 6-8 schools joining the study each year. The investigators will assess the effectiveness of Asthma-PASS in reducing asthma morbidity, and improving PA as well as additional clinical and functional outcomes. The investigators will also identify potential mediators and moderators of the intervention effect. They will evaluate the process of intervention implementation by applying the RE-AIM framework.
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Asthma in Children
Eligibility Criteria
Inclusion Criteria:
* Physician-diagnosed asthma (based on parent report with validation from the child's physician).
* Mild persistent or more severe asthma, or asthma that is uncontrolled despite therapy
* Attending kindergarten through 5th grade in Bronx elementary schools
* Parent is able to speak and understand either English or Spanish.
* Consent from the primary caregiver, caregiver permission for child participation as well as assent from the child (for age 7 and above).
Exclusion Criteria:
* No access to a phone to conduct follow-up surveys.
* Family plans to leave the school or city in less than 6 months.
* The child has other significant medical conditions, such as congenital heart disease, cystic fibrosis, or other chronic lung disease.
* Child is unable to participate in routine PE classes as per physician-completed sports participation form.
* Children in foster care or other situations in which consent cannot be obtained from a guardian.
* Child is a participant in a concurrent asthma intervention study.
* Physician-diagnosed asthma (based on parent report with validation from the child's physician).
* Mild persistent or more severe asthma, or asthma that is uncontrolled despite therapy
* Attending kindergarten through 5th grade in Bronx elementary schools
* Parent is able to speak and understand either English or Spanish.
* Consent from the primary caregiver, caregiver permission for child participation as well as assent from the child (for age 7 and above).
Exclusion Criteria:
* No access to a phone to conduct follow-up surveys.
* Family plans to leave the school or city in less than 6 months.
* The child has other significant medical conditions, such as congenital heart disease, cystic fibrosis, or other chronic lung disease.
* Child is unable to participate in routine PE classes as per physician-completed sports participation form.
* Children in foster care or other situations in which consent cannot be obtained from a guardian.
* Child is a participant in a concurrent asthma intervention study.
Inclusion Criteria
Inclusion Criteria:
* Physician-diagnosed asthma (based on parent report with validation from the child's physician).
* Mild persistent or more severe asthma, or asthma that is uncontrolled despite therapy
* Attending kindergarten through 5th grade in Bronx elementary schools
* Parent is able to speak and understand either English or Spanish.
* Consent from the primary caregiver, caregiver permission for child participation as well as assent from the child (for age 7 and above).
* Physician-diagnosed asthma (based on parent report with validation from the child's physician).
* Mild persistent or more severe asthma, or asthma that is uncontrolled despite therapy
* Attending kindergarten through 5th grade in Bronx elementary schools
* Parent is able to speak and understand either English or Spanish.
* Consent from the primary caregiver, caregiver permission for child participation as well as assent from the child (for age 7 and above).
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
11 Years
Minimum Age
5 Years
NCT Id
NCT04576442
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2019-10930
Overall Status
Active, not recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Evaluation of the Asthma Management Program to Promote Activity for Students in Schools (Asthma-PASS)
Primary Outcomes
Outcome Description
Change from baseline in the number of SFDs will be assessed. Caregivers will report the number of days their child experienced no symptoms of asthma (defined as 24 hours with no coughing, wheezing, chest tightness, or shortness of breath) over the prior 14 day period. Symptom diaries provided as part of the study will be used to assist with recall. The trial will be successful if the intervention demonstrates a significantly greater improvement over time on SFDs at any of the 4 post-baseline assessments.
Outcome Measure
Change in the number of Symptom free days (SFDs)
Outcome Time Frame
Baseline, 3, 6, 9, and 12 months
Secondary Ids
Secondary Id
R33HL147908
Secondary Outcomes
Outcome Description
Physical activity will be assessed by the number of minutes the child engages in 'moderate-vigorous' physical activity based on measurements taken using the ActiGraph GT3X+ activity monitor, a small, tri-axial micro-electromechanical system (MEMS) based accelerometer. Measurements will be taken over 7 consecutive days at baseline, 3, 6 and 9 months using the activity monitor. Children will wear the monitor on their waist, secured using an elastic belt. The number of minutes the child is in 'moderate-vigorous' physical activity will be summarized by study arm.
Outcome Time Frame
Baseline, 3, 6 and 9 months
Outcome Measure
Physical activity
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Child
Locked Fields
Render the field
Maximum Age Number (converted to Years and rounded down)
11
Minimum Age Number (converted to Years and rounded down)
5
Investigators
Investigator Type
Principal Investigator
Investigator Name
Marina Reznik
Investigator Email
MREZNIK@montefiore.org
Investigator Phone
718-405-5260