Clinical trial NCT05726487: Physical Activity Intervention for Black Women With Asthma
Official title: ACTION (physicAl aCtiviTy In minOrity womeN With Asthma) Intervention: Efficacy to Implementation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asthma
Keywords: Black women
Asthma Control Questionnaire
Physical Activity
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: University of Illinois at Chicago
name: University of Texas at Austin
First posted: 2023-02-14
Enrollment: 224
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Physical inactivity is associated with poor asthma control and quality of life, and greater health care utilization. Rates of physical inactivity, asthma, and asthma mortality among Black women are higher than those of their White counterparts. Our formative work identified barriers to PA among Black women with asthma including a lack of social support, self-efficacy, unsafe neighborhood and fear related to experiences with life-threatening asthma exacerbations. Given the unique barriers to PA and high rates of physical inactivity that are associated with poor asthma outcomes in Black women, there is an urgent need to optimize PA interventions for this population. The proposed study uses our theory-driven intervention (ACTION: A lifestyle physiCal acTivity Intervention for minOrity womeN with asthma) to deliver a 24-week lifestyle physical activity intervention designed for and by urban Black women with asthma. Participants will be recruited through two urban health care systems that care for a diverse urban Black populations. Participants will be randomized to one of two groups: 1) ACTION intervention (group sessions, physical activity self-monitoring and text-based support for goal-setting), or 2) education control (an individual asthma education session and text messages related to asthma education). Participants will be followed for an additional 24-weeks after the intervention to assess for the maintenance of intervention effects on asthma health outcomes. We are proposing an efficacy study that focuses on asthma outcomes (Aim 1A/B), explores behavioral mechanisms of the intervention (Aim 2) and assesses factors that influence its reach and implementation potential (Aim 3). This trial will provide the first ever evidence of the efficacy of a lifestyle physical activity intervention among urban Black women with asthma, a population that is understudied yet plagued by low levels of PA and poor health outcomes. Our study has high potential to advance clinical treatment of asthma, and further the mechanistic understanding of physical activity interventions in minority populations living in low-resourced urban environments.


Eligibility criteria: Inclusion Criteria:

* Self-identify as female and Black or African-American
* 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:

* Plans to relocate outside of the Chicagoland area during the study period
* 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

Primary outcomes:
measure: Asthma Control Questionnaire
timeFrame: 24-weeks
Secondary outcomes:
measure: Asthma Control Questionnaire
timeFrame: 48-weeks
measure: Mini-asthma quality of life questionnaire
timeFrame: 24- and 48-weeks
measure: Asthma exacerbations
timeFrame: 24- and 48-weeks
measure: Healthcare Utilization (ED, urgent care, and hospitalizations)
timeFrame: 24- and 48-weeks
measure: Self-efficacy for walking scale
timeFrame: 24- and 48-weeks
measure: Social support for exercise
timeFrame: 24- and 48-weeks
measure: Self-regulation
timeFrame: 24- and 48-weeks
measure: Light Physical Activity
timeFrame: 24-weeks
measure: Moderate Physical Activity
timeFrame: 24-weeks
measure: Moderate-Vigorous Physical Activity
timeFrame: 24-weeks
measure: Vigorous Physical Activity
timeFrame: 24-weeks
measure: Daily Steps
timeFrame: 24-weeks
measure: PWMAQ
timeFrame: 24-weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois Chicago
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Sharmilee Nyenhuis, MD
role: PRINCIPAL_INVESTIGATOR
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