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| ID | Type | Description | Link |
|---|---|---|---|
| K01HL133370 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACTION Intervention | Experimental | 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. |
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| Enhanced usual care | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACTION Intervention | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Intervention-Recruitment | The total number of participants recruited and consented in the study. | 24 weeks |
| Feasibility of Intervention-Withdrawals | Number of participants that withdrew from the study | 24 weeks |
| Feasibility of Lifestyle PA Intervention | Number of participants that completed 24-week outcomes assessment | 24 weeks |
| Acceptability of Lifestyle PA Intervention | Unabbreviated scale title: ACTION Satisfaction Scale. Acceptability was measured using a 7-point Likert scale with 1 representing not satisfied and 7 representing very satisfied. Higher scores mean more satisfied with the intervention. The range is from 1-7. | 24-weeks |
| Acceptability of Lifestyle PA Intervention-Qualitative Data | Intervention participants were asked open-ended questions about their satisfaction with the study. Responses were written down by the participant and data collector. It is not possible to summarize the data collected from the open-ended questions in tabular form as it is qualitative data. | 24-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Light Physical Activity Levels | as measured by accelerometer and using proprietary Actilife software | 24 weeks |
| Asthma Quality of Life Questionnaire (AQLQ) | The Asthma Quality of Life Questionnaire (AQLQ) is a 32-item questionnaire. It has 4 domains: symptoms (12 items), activity limitation (6 generic and 5 patient-specific items), emotional function (5 items), and environmental stimuli (4 items). The AQLQ items are each scored on a 7-point Likert scale, with 1 representing maximal impairment and 7 representing no impairment. Scores range 1-7, with higher scores indicating better quality of life. A total score was calculated by summing all responses for each question and then dividing by the number of items in the questionnaire (n=32). Subdomains were not reported/used. |
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Inclusion Criteria:
Exclusion Criteria: • Plans to relocate outside of the Chicagoland area during the study period.
The focus population for this study is sedentary African-American (AA) women with asthma. All participants included in the study will self-identify themselves as female and AA. This study population was chosen as AA women are disproportionately impacted by physical inactivity and asthma compared to Caucasian men and women and AA men.
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| Name | Affiliation | Role |
|---|---|---|
| Sharmilee M Nyenhuis, MD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois Hospital and Health Sciences System | Chicago | Illinois | 60612 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | ACTION Intervention | Women in the ACTION intervention will attend 1 asthma education/physical activity session and 5 group sessions 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. 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. |
| FG001 | 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. Enhanced usual care: Participants will attend 1 two hour asthma education/physical activity session. 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 will 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 24-week Data Collection |
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| 36-week Data Collection |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of Intervention-Recruitment | The total number of participants recruited and consented in the study. | Posted | Number | participants | 24 weeks |
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36 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ACTION Intervention | Women in the ACTION intervention will attend 1 asthma education/physical activity session and 5 group sessions 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. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| skin rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sharmilee Nyenhuis | University of Illinois at Chicago | 3124131655 | snyenhui@uic.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 23, 2021 | Dec 18, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Enhanced usual care | 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. |
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| 24 weeks |
| Asthma Control Questionnaire (ACQ-6) | Unabbreviated scale title: Asthma control questionnaire (ACQ) The ACQ score correlates with a measure of asthma control based on the GINA/NIH criteria. ACQ includes 6 questions on symptoms, activity limitation and beta2-agonist use. Each question is scored from 0 to 6 with the total score being the average of the questions. The ACQ score ranges between 0 (well controlled) and 6 (extremely poorly controlled). Recent studies show that a score of 1.5 or more on the 6-item Asthma Control Questionnaire (ACQ) indicates that a patient has inadequate asthma control.Higher scores mean poorer asthma control. | 24 weeks |
| Daily Step Counts | as measured by accelerometer | 24 weeks |
| Moderate Physical Activity Levels | as measured by accelerometer and using proprietary Actilife software | 24 weeks |
| Vigorous Physical Activity Levels | as measured by accelerometer and using proprietary Actilife software | 24 weeks |
| NOT COMPLETED |
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| BG001 | 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. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
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| Household Income (<$30,000/year) | Count of Participants | Participants |
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| Insurance status (medicare/medicaid/medical assistance) | Count of Participants | Participants |
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| Marital status (Single/divorced/widowed) | Count of Participants | Participants |
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| Forced Expiratory Volume in 1 second | Mean | Standard Deviation | Liters |
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| Forced Expiratory Volume in 1 second % predicted | Mean | Standard Deviation | % predicted |
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| Unscheduled office visits in past 6 mo (Yes) | Count of Participants | Participants |
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| Emergency Department visit(s) in the past 6 mo (yes) | Count of Participants | Participants |
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| Asthma control Questionnaire(ACQ-6) | Asthma control questionnaire (ACQ): The ACQ score correlates with a measure of asthma control based on the GINA/NIH criteria. ACQ includes 6 questions on symptoms, activity limitation and beta2-agonist use. Each question is scored from 0 to 6 with the total score being the average of the questions. The ACQ score ranges between 0 (well controlled) and 6 (extremely poorly controlled). Recent studies show that a score of 1.5 or more on the 7-item Asthma Control Questionnaire (ACQ) indicates that a patient has inadequate asthma control. | Mean | Standard Deviation | units on a scale |
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| Asthma quality of life (AQLQ) | The Asthma Quality of Life Questionnaire (AQLQ) is a 32-item questionnaire. It has 4 domains: symptoms (12 items), activity limitation (6 generic and 5 patient-specific items), emotional function (5 items), and environmental stimuli (4 items). The AQLQ items are each scored on a 7-point Likert scale, with 1 representing maximal impairment and 7 representing no impairment. Scores range 1-7, with higher scores indicating better quality of life. Total score is shown here as subdomains were not analyzed. | Mean | Standard Deviation | units on a scale |
|
| Daily steps | Mean | Standard Deviation | steps/day |
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| Light Physical Activity | Mean | Standard Deviation | minutes/day |
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| Moderate Physical Activity | Mean | Standard Deviation | minutes/day |
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| Vigorous Physical Activity | Mean | Standard Deviation | minutes/day |
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| Primary | Feasibility of Intervention-Withdrawals | Number of participants that withdrew from the study | Posted | Count of Participants | Participants | 24 weeks |
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| Primary | Feasibility of Lifestyle PA Intervention | Number of participants that completed 24-week outcomes assessment | Posted | Count of Participants | Participants | 24 weeks |
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| Primary | Acceptability of Lifestyle PA Intervention | Unabbreviated scale title: ACTION Satisfaction Scale. Acceptability was measured using a 7-point Likert scale with 1 representing not satisfied and 7 representing very satisfied. Higher scores mean more satisfied with the intervention. The range is from 1-7. | Acceptability of the intervention was measured in only intervention participants | Posted | Mean | Standard Deviation | units on a scale | 24-weeks |
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| Primary | Acceptability of Lifestyle PA Intervention-Qualitative Data | Intervention participants were asked open-ended questions about their satisfaction with the study. Responses were written down by the participant and data collector. It is not possible to summarize the data collected from the open-ended questions in tabular form as it is qualitative data. | Intervention satisfaction was only collected in those randomized to intervention group.It is not possible to summarize the data collected from the open-ended questions in tabular form. | Posted | 24-weeks |
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| Secondary | Light Physical Activity Levels | as measured by accelerometer and using proprietary Actilife software | The number of participants does not equal 19 (Intervention) and 21 (EUC) as we lost a number of accelerometers in the mail or did not have adequate amount of data (A minimum of 10 hours of wear time for at least three days over a 1 week period). | Posted | Mean | Standard Deviation | minutes per day | 24 weeks |
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| Secondary | Asthma Quality of Life Questionnaire (AQLQ) | The Asthma Quality of Life Questionnaire (AQLQ) is a 32-item questionnaire. It has 4 domains: symptoms (12 items), activity limitation (6 generic and 5 patient-specific items), emotional function (5 items), and environmental stimuli (4 items). The AQLQ items are each scored on a 7-point Likert scale, with 1 representing maximal impairment and 7 representing no impairment. Scores range 1-7, with higher scores indicating better quality of life. A total score was calculated by summing all responses for each question and then dividing by the number of items in the questionnaire (n=32). Subdomains were not reported/used. | Posted | Mean | Standard Deviation | score on a scale | 24 weeks |
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| Secondary | Asthma Control Questionnaire (ACQ-6) | Unabbreviated scale title: Asthma control questionnaire (ACQ) The ACQ score correlates with a measure of asthma control based on the GINA/NIH criteria. ACQ includes 6 questions on symptoms, activity limitation and beta2-agonist use. Each question is scored from 0 to 6 with the total score being the average of the questions. The ACQ score ranges between 0 (well controlled) and 6 (extremely poorly controlled). Recent studies show that a score of 1.5 or more on the 6-item Asthma Control Questionnaire (ACQ) indicates that a patient has inadequate asthma control.Higher scores mean poorer asthma control. | Posted | Mean | Standard Deviation | score on a scale | 24 weeks |
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| Secondary | Daily Step Counts | as measured by accelerometer | The number of participants does not equal 19 (Intervention) and 21 (EUC) as we lost a number of accelerometers in the mail or did not have adequate amount of data (A minimum of 10 hours of wear time for at least three days over a 1 week period). | Posted | Mean | Standard Deviation | steps/day | 24 weeks |
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| Secondary | Moderate Physical Activity Levels | as measured by accelerometer and using proprietary Actilife software | The number of participants does not equal 19 (Intervention) and 21 (EUC) as we lost a number of accelerometers in the mail or did not have adequate amount of data (A minimum of 10 hours of wear time for at least three days over a 1 week period). | Posted | Mean | Standard Deviation | minutes per day | 24 weeks |
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| Secondary | Vigorous Physical Activity Levels | as measured by accelerometer and using proprietary Actilife software | The number of participants does not equal 19 (Intervention) and 21 (EUC) as we lost a number of accelerometers in the mail or did not have adequate amount of data (A minimum of 10 hours of wear time for at least three days over a 1 week period). | Posted | Mean | Standard Deviation | minutes per day | 24 weeks |
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| 0 |
| 25 |
| 0 |
| 25 |
| 2 |
| 25 |
| EG001 | 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. Enhanced usual care: Participants will attend 1 two hour asthma education/physical activity session. 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 will 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. | 0 | 28 | 0 | 28 | 1 | 28 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |