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NCT Number: NCT05726487

Physical Activity Intervention for Black Women With Asthma

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago, Chicago, Illinois, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACTION Intervention

Behavioral

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

Other

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.

Primary outcomes

  1. Asthma Control Questionnaire

    Time frame: 24-weeks

    Validated questionnaire

Secondary outcomes

  1. Asthma Control Questionnaire

    Time frame: 48-weeks

    Validated questionnaire

  2. Mini-asthma quality of life questionnaire

    Time frame: 24- and 48-weeks

    Validated questionnaire

  3. Asthma exacerbations

    Time frame: 24- and 48-weeks

    Self-reported measure

  4. Healthcare Utilization (ED, urgent care, and hospitalizations)

    Time frame: 24- and 48-weeks

    Self-reported measure

  5. Self-efficacy for walking scale

    Time frame: 24- and 48-weeks

    Survey

  6. Social support for exercise

    Time frame: 24- and 48-weeks

    Survey

  7. Self-regulation

    Time frame: 24- and 48-weeks

    Measured by exercise self-regulation questionnaire (SRQ-E) and step goals achieved

  8. Light Physical Activity

    Time frame: 24-weeks

    Physical activity measure. Measured by Actigraph GT3XP-BTLE waist-based Accelerometer.

  9. Moderate Physical Activity

    Time frame: 24-weeks

    Physical activity measure. Measured by Actigraph GT3XP-BTLE waist-based Accelerometer.

  10. Moderate-Vigorous Physical Activity

    Time frame: 24-weeks

    Physical activity measure. Measured by Actigraph GT3XP-BTLE waist-based Accelerometer.

  11. Vigorous Physical Activity

    Time frame: 24-weeks

    Physical activity measure. Measured by Actigraph GT3XP-BTLE waist-based Accelerometer.

  12. Daily Steps

    Time frame: 24-weeks

    Physical activity measure. Measured by Actigraph GT3XP-BTLE waist-based Accelerometer

  13. PWMAQ

    Time frame: 24-weeks

    Physical activity measure. Validated questionnaire

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • University of Illinois at Chicago
  • University of Texas at Austin

Registry information

Official study title

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

Acronym: ACTION E2I

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 14, 2023
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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