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ACTION E2I: Physical Activity Intervention for Black Women With Asthma

Sponsor
University of Chicago (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05726487
Collaborator
University of Illinois at Chicago (Other), University of Texas at Austin (Other)
224
Enrollment
2
Arms
48.9
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: ACTION Intervention
  • Other: Education Control
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
224 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
ACTION (physicAl aCtiviTy In minOrity womeN With Asthma) Intervention: Efficacy to Implementation
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2026
Anticipated Study Completion Date :
Mar 1, 2027

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Asthma Control Questionnaire [24-weeks]

    Validated questionnaire

Secondary Outcome Measures

  1. Asthma Control Questionnaire [48-weeks]

    Validated questionnaire

  2. Mini-asthma quality of life questionnaire [24- and 48-weeks]

    Validated questionnaire

  3. Asthma exacerbations [24- and 48-weeks]

    Self-reported measure

  4. Healthcare Utilization (ED, urgent care, and hospitalizations) [24- and 48-weeks]

    Self-reported measure

  5. Self-efficacy for walking scale [24- and 48-weeks]

    Survey

  6. Social support for exercise [24- and 48-weeks]

    Survey

  7. Self-regulation [24- and 48-weeks]

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

  8. Light Physical Activity [24-weeks]

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

  9. Moderate Physical Activity [24-weeks]

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

  10. Moderate-Vigorous Physical Activity [24-weeks]

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

  11. Vigorous Physical Activity [24-weeks]

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

  12. Daily Steps [24-weeks]

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

  13. PWMAQ [24-weeks]

    Physical activity measure. Validated questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Chicago
ClinicalTrials.gov Identifier:
NCT05726487
Other Study ID Numbers:
  • IRB22-0911
First Posted:
Feb 14, 2023
Last Update Posted:
Feb 14, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Chicago
Black women
Asthma Control Questionnaire
Physical Activity
Additional relevant MeSH terms:
Asthma

Study Results

No Results Posted as of Feb 14, 2023