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

Primary Purpose

Asthma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ACTION Intervention
Education Control
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Black women, Asthma Control Questionnaire, Physical Activity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Illinois ChicagoRecruiting
  • University of ChicagoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

ACTION Intervention

Education Control

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Asthma Control Questionnaire
Validated questionnaire

Secondary Outcome Measures

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

Full Information

First Posted
January 11, 2023
Last Updated
August 11, 2023
Sponsor
University of Chicago
Collaborators
University of Illinois at Chicago, University of Texas at Austin
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1. Study Identification

Unique Protocol Identification Number
NCT05726487
Brief Title
Physical Activity Intervention for Black Women With Asthma
Acronym
ACTION E2I
Official Title
ACTION (physicAl aCtiviTy In minOrity womeN With Asthma) Intervention: Efficacy to Implementation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 4, 2023 (Actual)
Primary Completion Date
December 30, 2025 (Anticipated)
Study Completion Date
June 3, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
University of Illinois at Chicago, University of Texas at Austin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Black women, Asthma Control Questionnaire, Physical Activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
224 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sharmilee Nyenhuis, MD
Phone
(773) 834-7121
Email
snyenhuis@bsd.uchicago.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharmilee Nyenhuis, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Sharp, BSN, MA, PhD
Phone
312-413-5621
Email
sharpl@uic.edu
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharmilee Nyenhuis, MD
Phone
773-834-7121
Email
snyenhuis@bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Ellen Davis, MS
Phone
(773) 795-0445
Email
ellen.davis@bsd.uchicago.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Physical Activity Intervention for Black Women With Asthma

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