Physical Activity Intervention for Black Women With Asthma

Study Overview
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Brief Summary
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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.

Official Title
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ACTION (physicAl aCtiviTy In minOrity womeN With Asthma) Intervention: Efficacy to Implementation

Conditions
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Asthma

Intervention / Treatment
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* Behavioral: ACTION Intervention
* Other: Education Control


Participation Criteria
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Eligibility Criteria
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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 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 Currently pregnant, planning to become pregnant over the next 12 months 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACTION Intervention<br>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) | Behavioral: ACTION Intervention<br>* 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.<br>|
| Other: Education Control<br>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) | Other: Education Control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Control Questionnaire | Validated questionnaire | 24-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Control Questionnaire | Validated questionnaire | 48-weeks | 
| Mini-asthma quality of life questionnaire | Validated questionnaire | 24- and 48-weeks | 
| Asthma exacerbations | Self-reported measure | 24- and 48-weeks | 
| Healthcare Utilization (ED, urgent care, and hospitalizations) | Self-reported measure | 24- and 48-weeks | 
| Self-efficacy for walking scale | Survey | 24- and 48-weeks | 
| Social support for exercise | Survey | 24- and 48-weeks | 
| Self-regulation | Measured by exercise self-regulation questionnaire (SRQ-E) and step goals achieved | 24- and 48-weeks | 
| Light Physical Activity | Physical activity measure. Measured by Actigraph GT3XP-BTLE waist-based Accelerometer. | 24-weeks | 
| Moderate Physical Activity | Physical activity measure. Measured by Actigraph GT3XP-BTLE waist-based Accelerometer. | 24-weeks | 
| Moderate-Vigorous Physical Activity | Physical activity measure. Measured by Actigraph GT3XP-BTLE waist-based Accelerometer. | 24-weeks | 
| Vigorous Physical Activity | Physical activity measure. Measured by Actigraph GT3XP-BTLE waist-based Accelerometer. | 24-weeks | 
| Daily Steps | Physical activity measure. Measured by Actigraph GT3XP-BTLE waist-based Accelerometer | 24-weeks | 
| PWMAQ | Physical activity measure. Validated questionnaire | 24-weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Black women, Asthma Control Questionnaire, Physical Activity