Physical Activity Intervention for Black Women With Asthma
NCT ID: NCT05726487
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
224 participants
INTERVENTIONAL
2023-05-04
2026-12-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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ACTION Intervention
Orientation (week 0): 1 group session Induction phase (weeks 1-12): 8 weekly then 2 bi-weekly goal setting via text with health coach + 2 group sessions (week 5, 9) Adoptive phase (weeks 13-24): 2 monthly goal setting with remote health coach + 3 group sessions (week 13, 17, 21) Maintenance phase (weeks 25-48): 1 group session Outcome assessment (12-, 24-, and 48-weeks)
ACTION Intervention
Participants in the ACTION Intervention arm of the study will have group sessions, physical activity self-monitoring, text-based support for goal setting. Following this intervention participants will be followed for an additional 24-weeks to assess for the maintenance of intervention effects on asthma health outcomes.
Education Control
Orientation (week 0): 1 individual asthma education session Education texts: weekly (weeks 1-8), then bi-weekly (week 9-12), then monthly (weeks 13-24) Outcome assessments (12-, 24-, 48-weeks)
Education Control
Participants in the Education Control arm of the study will receive and individual asthma education session and text messages related to asthma education. Following this intervention participants will be followed for an additional 24-weeks to assess for the maintenance of intervention effects on asthma health outcomes.
Interventions
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ACTION Intervention
Participants in the ACTION Intervention arm of the study will have group sessions, physical activity self-monitoring, text-based support for goal setting. Following this intervention participants will be followed for an additional 24-weeks to assess for the maintenance of intervention effects on asthma health outcomes.
Education Control
Participants in the Education Control arm of the study will receive and individual asthma education session and text messages related to asthma education. Following this intervention participants will be followed for an additional 24-weeks to assess for the maintenance of intervention effects on asthma health outcomes.
Eligibility Criteria
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Inclusion Criteria
* Age \>/= 18
* Physician-diagnosed persistent asthma that is sub-optimally controlled based on Asthma Control Test (ACT \< 20) OR history in the past year of an asthma exacerbation (a need for systemic corticosteroids or hospital admission or emergency treatment for worsening asthma)
* Willing to enroll and provide written-informed consent
* Willing to be randomly assigned to treatment or control group
* Low- active: engages in less than 150 minutes per week of moderate-to- vigorous physical activity
* Has a smartphone and texts every day or almost everyday
Exclusion Criteria
* Unable to ambulate without the use of a wheelchair or scooter
* Diagnosis of COPD (emphysema or chronic bronchitis) suggested by patient report of doctor diagnosis or smoking history (≥ 20 pack years)
* Current tobacco smoker
* A contraindication to exercise as indicated by the Physical Activity Readiness Questionnaire unless written permission by a health care provider
* Significant medical (e.g., unstable heart disease, uncontrolled high blood pressure, active cancer treatment in past 1 year, end-stage organ failure) or psychiatric (e.g., active bipolar disorder, psychosis) comorbidities
* Participation in another physical activity or asthma research program
* Asthma exacerbation, defined by an urgent care visit for asthma in the last 4 weeks, or need for acute course of systemic corticosteroids for asthma in the last 4 weeks
* Family/household member of another study participant or staff member
* Inability to speak, read or understand English
* Investigator discretion for safety or protocol adherence reasons
* Unable or unwilling to provide complete accelerometry data at the baseline assessment after two opportunities to wear the monitor
18 Years
FEMALE
Yes
Sponsors
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University of Illinois at Chicago
OTHER
University of Texas at Austin
OTHER
University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Sharmilee Nyenhuis, MD
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
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University of Illinois Chicago
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Countries
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References
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Other Identifiers
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IRB22-0911
Identifier Type: -
Identifier Source: org_study_id