physicAl aCtiviTy In minOrity womeN With Asthma Intervention

NCT ID: NCT03265665

Last Updated: 2022-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2019-09-30

Brief Summary

The ACTION intervention: physicAl aCtiviTy In minOrity womeN with asthma is a 3lifestyle physical activity intervention refined to be applicable for sedentary African American (AA) women with asthma. The main outcome of this study is to test the feasibility, acceptability and estimate the efficacy of the ACTION intervention in a randomized controlled pilot of 80 AA women with asthma within a pragmatic community setting at 24-weeks.

Detailed Description

Asthma is a highly prevalent chronic disease that disproportionately impacts African American (AA) women. AA women have poorer asthma-related quality of life and higher rates of asthma exacerbations, healthcare utilization and mortality compared to Caucasian women. Further, AA women are less physically active than any other subgroup of adults, which may help explain the asthma health disparities, found between AA and Caucasian women. Physical inactivity among individuals with asthma is associated with poor asthma control and respiratory function, greater health care utilization, and poorer quality of life. Given the connection between poor asthma outcomes and physical inactivity, addressing physical activity (PA) among sedentary AA women with asthma is imperative. Physical activity demonstrated improvement in asthma outcomes specifically asthma control, quality of life and healthcare utilization. Despite these benefits, fewer than 25% of AA women with asthma engage in regular physical activity. The ACTION intervention: physicAl aCtiviTy In minOrity womeN with asthma is a lifestyle PA intervention refined to be applicable for sedentary AA women with asthma.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ACTION Intervention

Women in the ACTION intervention will attend 1 asthma education/physical activity session and 5 group sessions in community location convenient to participants during the adoptive phase (24-weeks) and 1 group session during the maintenance phase (12-weeks). Each session will last approximately 2 hours. Participants will be given Fitbit Charge HR to monitor their daily steps and will be sent motivational, educational and reminder text messages up to 3 times per week.

Group Type: EXPERIMENTAL

ACTION Intervention

Intervention Type: BEHAVIORAL

The intervention is based on the Women's Lifestyle Physical Activity Program, a culturally sensitive lifestyle physical activity intervention for African American (AA) women. There are 2 phases to the intervention: Adoptive (24 weeks) and Maintenance (12 weeks). 3 motivational/reminder texts will be made each week during the adoption phase. 5 Group sessions(adoptive): Participants will be given individualized step goals, watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking. 1 Group session (maintenance): watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking, reinforce barriers and facilitators to walking. An interventionist will lead a discussion on role-modeling and encouraging problem solving. Each intervention group will have 10 women with 1 interventionist. Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks.

Enhanced usual care

Women in the Enhanced usual care arm will attend 1 asthma education/physical activity session and be given a Fitbit Charge HR to monitor their daily steps. They will be given a static step goal to achieve. Only reminder text messages for data collection visits will be sent.

Group Type: OTHER

Enhanced usual care

Intervention Type: OTHER

Participants will attend 1 two hour asthma education/physical activity session at community location near them. Participants will review basic asthma topics in a didactic session and will include exercising with asthma and exercise-induced asthma. Participants will be given Fitbit and provided instructions on how to use it. Participants may receive 2 newsletters with information on asthma and reminder texts regarding data collection visits.

Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks.

Interventions

ACTION Intervention

The intervention is based on the Women's Lifestyle Physical Activity Program, a culturally sensitive lifestyle physical activity intervention for African American (AA) women. There are 2 phases to the intervention: Adoptive (24 weeks) and Maintenance (12 weeks). 3 motivational/reminder texts will be made each week during the adoption phase. 5 Group sessions(adoptive): Participants will be given individualized step goals, watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking. 1 Group session (maintenance): watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking, reinforce barriers and facilitators to walking. An interventionist will lead a discussion on role-modeling and encouraging problem solving. Each intervention group will have 10 women with 1 interventionist. Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks.

Intervention Type: BEHAVIORAL

Enhanced usual care

Participants will attend 1 two hour asthma education/physical activity session at community location near them. Participants will review basic asthma topics in a didactic session and will include exercising with asthma and exercise-induced asthma. Participants will be given Fitbit and provided instructions on how to use it. Participants may receive 2 newsletters with information on asthma and reminder texts regarding data collection visits.

Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks.

Intervention Type: OTHER

Other Intervention Names

Group sessions

Eligibility Criteria

Inclusion Criteria

• Self-identify as female and black or AA
• Age 18-70
• Sub-optimally controlled persistent asthma based on Asthma Control Test (ACT <20)
• Wiling to enroll and provide written-informed consent
• Willing to be randomly assigned to treatment or control group

Exclusion Criteria

• Unable to ambulate without human assistance (ie. use of a wheelchair, scooter)
• History of significant mental illness (e.g. uncontrolled bipolar disorder, psychoses)
• Currently pregnant, planning to become pregnant over the next 3 months
• Diagnosis of COPD (emphysema or chronic bronchitis) suggested by patient report of doctor diagnosis or smoking history (>20 pack years)
• Poorly controlled high blood pressure (BP >180/100 at baseline visit)
• 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
• Participation in ACTION focus groups (Aim 1) or pre-pilot (Aim 2) of the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Sharmilee Nyenhuis

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sharmilee M Nyenhuis, MD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

University of Illinois Hospital and Health Sciences System

Chicago, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

K01HL133370

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2016-0466

Identifier Type: -

Identifier Source: org_study_id