Physical Activity Intervention for Black Women With Asthma

Asthma Clinical Trial

— ACTION E2I  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05726487
• Other study ID #: IRB22-0911
• Status: Recruiting
• Phase: N/A
• Start date: May 4, 2023
• Est. completion date: June 3, 2026

Study information

• Verified date: May 2024
• Source: University of Chicago
• Contact: Sharmilee Nyenhuis, MD
• Phone: (773) 834-7121
• Email: snyenhuis[@]bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 224
• Est. completion date: June 3, 2026
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois
United States	University of Illinois Chicago	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
University of Chicago	University of Illinois at Chicago, University of Texas at Austin

Country where clinical trial is conducted

United States, 

References & Publications (41)

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* Note: There are 41 references in all — Click here to view all references

Outcome

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