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Accepted for/Published in: JMIR Research Protocols

Date Submitted: Dec 21, 2023
Open Peer Review Period: Dec 20, 2023 - Dec 22, 2023
Date Accepted: Dec 22, 2023
(closed for review but you can still tweet)

The final, peer-reviewed published version of this preprint can be found here:

Physical Activity Intervention for Urban Black Women With Asthma: Protocol for a Randomized Controlled Efficacy Study

Davis E, Townsend E, Cavaliar A, Chen YF, Edwards-Hart D, Kitsiou S, Kowalczyk W, Mansur I, Okpara E, Powell K, Press VG, Ramirez T, Salvo D, Sharp LK, Wright B, Nyenhuis S

Physical Activity Intervention for Urban Black Women With Asthma: Protocol for a Randomized Controlled Efficacy Study

JMIR Res Protoc 2024;13:e55700

DOI: 10.2196/55700

PMID: 38324365

PMCID: 10882465

A Physical Activity Intervention for Urban Black Women with Asthma: Protocol for a Randomized Controlled Efficacy Study

  • Ellen Davis; 
  • Elizabeth Townsend; 
  • Aero Cavaliar; 
  • Yi-Fan Chen; 
  • Dameka Edwards-Hart; 
  • Spyros Kitsiou; 
  • Wiktoria Kowalczyk; 
  • Iliana Mansur; 
  • Ebere Okpara; 
  • Karen Powell; 
  • Valerie G. Press; 
  • Toni Ramirez; 
  • Deborah Salvo; 
  • Lisa K. Sharp; 
  • Brittani Wright; 
  • Sharmilee Nyenhuis

ABSTRACT

Background:

Black women experience higher prevalence of poor asthma outcomes and physical inactivity than their white counterparts. Black women comprise a particularly vulnerable group of asthma patients, with some of the highest rates of asthma in adults, high healthcare utilization (emergency department [ED] visits, hospitalizations) and the highest crude asthma mortality rate of all race/ethnicity groups. Despite recommendations to engage in regular physical activity, fewer than 15% of Black women meet 2008 National Physical Activity Guidelines, the lowest of all racial subgroups of adults. Given the connection between physical inactivity and poor asthma outcomes, addressing physical activity among Black women with asthma is imperative.

Objective:

This 2-arm randomized controlled trial aims to: (1) determine the efficacy of a lifestyle walking intervention on asthma control compared to an education (control) group over 24-weeks, (2) examine the maintenance effects of the lifestyle walking intervention on asthma control at 48 weeks, (3) explore the behavioral mediators (e.g. self-efficacy, social support, self-regulation and daily physical activity levels) and contextual moderators (e.g. baseline asthma severity, neighborhood environment, co-morbid conditions, social determinants of health) that contribute to treatment responsiveness, and (4) assess the reach and implementation potential of the lifestyle walking intervention.

Methods:

The proposed study (ACTION: A lifestyle physiCal acTivity Intervention for minOrity womeN with asthma) delivers a 24-week lifestyle walking intervention designed for and by urban Black women with asthma. Participants (n=224) will be recruited through two urban health care systems that care for a diverse urban Black population. Patients will be randomized to one of two groups: 1) ACTION intervention (group sessions, physical activity self-monitoring-Fitbit and text-based support for step-goal setting), or 2) education control (an individual asthma education session and text messages related to asthma education). Outcome assessments will take place at baseline, 12-, 24- and 48-weeks. The primary outcome is change in asthma control from baseline to week 24 as assessed by the asthma control questionnaire-6 (ACQ-6). Secondary outcomes include asthma-related quality of life, healthcare utilization and asthma exacerbations and behavioral outcomes: self-efficacy, self-regulation, social support and physical activity.

Results:

his study was funded by National Institute of Minority Health Disparities in August 2022. We pilot-tested our recruitment and intervention procedures and began recruitment in April 2023 with the enrollment of our first participant in May 2023. The anticipated completion of the study is April 2027.

Conclusions:

Methods The proposed study (ACTION: A lifestyle physiCal acTivity Intervention for minOrity womeN with asthma) delivers a 24-week lifestyle walking intervention designed for and by urban Black women with asthma. Participants (n=224) will be recruited through two urban health care systems that care for a diverse urban Black population. Patients will be randomized to one of two groups: 1) ACTION intervention (group sessions, physical activity self-monitoring-Fitbit and text-based support for step-goal setting), or 2) education control (an individual asthma education session and text messages related to asthma education). Outcome assessments will take place at baseline, 12-, 24- and 48-weeks. The primary outcome is change in asthma control from baseline to week 24 as assessed by the asthma control questionnaire-6 (ACQ-6). Secondary outcomes include asthma-related quality of life, healthcare utilization and asthma exacerbations and behavioral outcomes: self-efficacy, self-regulation, social support and physical activity. Results This study was funded by National Institute of Minority Health Disparities in August 2022. We pilot-tested our recruitment and intervention procedures and began recruitment in April 2023 with the enrollment of our first participant in May 2023. The anticipated completion of the study is April 2027. Conclusions This study will deliver a new approach to physical activity interventions in Black women with asthma and help to provide guidance for addressing physical activity within this subgroup. This Commented [SK9]: what procedures? Recruitment, intervention delivery, other, all? Commented [ED10R9]: I added recruitment and intervention procedures. Dr. Nyenhuis please confirm study will also provide a potential framework for future studies in minoritized populations with other disease conditions associated with low levels of physical activity Clinical Trial: NCT05726487


 Citation

Please cite as:

Davis E, Townsend E, Cavaliar A, Chen YF, Edwards-Hart D, Kitsiou S, Kowalczyk W, Mansur I, Okpara E, Powell K, Press VG, Ramirez T, Salvo D, Sharp LK, Wright B, Nyenhuis S

Physical Activity Intervention for Urban Black Women With Asthma: Protocol for a Randomized Controlled Efficacy Study

JMIR Res Protoc 2024;13:e55700

DOI: 10.2196/55700

PMID: 38324365

PMCID: 10882465

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