AsthmaNCT01873755
Addressing Barriers to Physical Activity in Inner-City Schoolchildren With Asthma
A study testing asthma physical activity intervention in people with Asthma and Children, run by Montefiore Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Asthma, Children, Physical Activity
- What is being tested?
- asthma physical activity intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2012to 20 Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children with active asthma attending 2nd-4th grades in Bronx
Who cannot join
- other medical conditions preventing participation in physical activity
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital at Montefiore, Albert Einstein College of Medicine
The Bronx, New York, 10467
About this study
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.
Read the 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.
- Conditions
- Asthma, Children, Physical Activity
- Being tested
- asthma physical activity intervention
- Keywords
- asthma, children, physical activity, school
- Medical subject headings
- Asthma, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
asthma physical activity interventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| asthma physical activity intervention | Experimental | two schools will receive intervention Receives: Behavioral: asthma physical activity intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in physical activity levels
physical activity levels will be measured with accelerometers
Measured: baseline, 6, 9, 12 months follow-up
Secondary outcomes (1)
change in Body Mass Index
BMI will be assessed by measuring height and weight of children
Measured: baseline, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2013 (estimated)
- Study start5 Dec 2012
- Primary completion28 May 2014
- Study completion20 Jun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Marina Reznik, MD, MS, Principal investigator, Children's Hospital at Montefiore, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01873755
- Sponsor's protocol ID
- 2012-443
- Other IDs
- 5K23HD065742
- Status last verified
- May 2023
- First submitted
- 4 Jun 2013
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 24796650Reznik 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.
PubMed 25454012Jaramillo 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.
PubMed 25729770Kornblit 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.
PubMed 29309846Cain 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.
PubMed 29084455Reznik 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.
PubMed 28696842Cain 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.
PubMed 27031532Reznik 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.
PubMed 27013055Reznik 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.
PubMed 40008092Reznik 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.
PubMed 31314614
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Barriers to Physical Activity in Inner-City Schoolchildren With Asthma
- ClinicalTrials.gov ID
- NCT01873755
- Acronym / sponsor ID
- 2012-443
- Conditions
- Asthma, Children, Physical Activity
- Keywords
- asthma, children, physical activity, school
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 5 Dec 2012 (actual)
- Primary completion
- 28 May 2014 (actual)
- Study completion
- 20 Jun 2014 (actual)
- First posted
- 10 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| asthma physical activity intervention | Experimental | Behavioral: asthma physical activity interventiontwo schools will receive intervention |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children with active asthma attending 2nd-4th grades in Bronx
Key exclusion criteria (1 listed)
- other medical conditions preventing participation in physical activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| asthma physical activity interventionSchool- 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 | Behavioural | asthma physical activity intervention |
Primary outcome
change in physical activity levels
Time frame: baseline, 6, 9, 12 months follow-up
physical activity levels will be measured with accelerometers
1 secondary outcome
change in Body Mass Index
Time frame: baseline, 6, 9 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Results publication: PubMed 24796650Walker 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.
- Results publication: PubMed 25454012Reznik 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.
- Results publication: PubMed 25729770Jaramillo 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.
- Results publication: PubMed 29309846Kornblit 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.
- Results publication: PubMed 29084455Cain 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.
- Results publication: PubMed 28696842Reznik 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.
- Results publication: PubMed 27031532Cain 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.
- Results publication: PubMed 27013055Reznik 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.
- Derived from this study: PubMed 40008092Reznik 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.
- Derived from this study: PubMed 31314614Reznik 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marina Reznik, MD, MS principal investigator
Children's Hospital at Montefiore, Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing asthma physical activity intervention in people with Asthma and Children, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in physical activity levels (time frame: baseline, 6, 9, 12 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01873755, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.