Physical Activity Intervention for Black Women With Asthma (ACTION E2I)

June 3, 2026 updated by: University of Chicago

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

224

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Chicago, Illinois, United States, 60607
        • University of Illinois Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
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
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
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

University of Illinois at Chicago
University of Texas at Austin

Investigators

  • Principal Investigator: Sharmilee Nyenhuis, MD, University of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2023

Primary Completion (Actual)

May 8, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

January 11, 2023

First Submitted That Met QC Criteria

February 2, 2023

First Posted (Actual)

February 14, 2023

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB22-0911

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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