Trial Outcomes & Findings for physicAl aCtiviTy In minOrity womeN With Asthma Intervention (NCT NCT03265665)
NCT ID: NCT03265665
Last Updated: 2022-02-23
Results Overview
The total number of participants recruited and consented in the study.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
53 participants
Primary outcome timeframe
24 weeks
Results posted on
2022-02-23
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
24-week Data Collection
STARTED
|
25
|
28
|
|
24-week Data Collection
COMPLETED
|
19
|
21
|
|
24-week Data Collection
NOT COMPLETED
|
6
|
7
|
|
36-week Data Collection
STARTED
|
23
|
26
|
|
36-week Data Collection
COMPLETED
|
17
|
18
|
|
36-week Data Collection
NOT COMPLETED
|
6
|
8
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
24-week Data Collection
Withdrawal by Subject
|
2
|
2
|
|
24-week Data Collection
Lost to Follow-up
|
4
|
5
|
|
36-week Data Collection
Lost to Follow-up
|
6
|
8
|
Baseline Characteristics
physicAl aCtiviTy In minOrity womeN With Asthma Intervention
Baseline characteristics by cohort
| Measure |
ACTION Intervention
n=25 Participants
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.
|
Enhanced Usual Care
n=28 Participants
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.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.87 years
STANDARD_DEVIATION 11 • n=5 Participants
|
43.84 years
STANDARD_DEVIATION 14 • n=7 Participants
|
43.38 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Body Mass Index
|
35.97 kg/m^2
STANDARD_DEVIATION 7 • n=5 Participants
|
36.86 kg/m^2
STANDARD_DEVIATION 12 • n=7 Participants
|
36.44 kg/m^2
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Household Income (<$30,000/year)
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Insurance status (medicare/medicaid/medical assistance)
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Marital status (Single/divorced/widowed)
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Forced Expiratory Volume in 1 second
|
2.06 Liters
STANDARD_DEVIATION 0.68 • n=5 Participants
|
2.04 Liters
STANDARD_DEVIATION 0.58 • n=7 Participants
|
2.04 Liters
STANDARD_DEVIATION 0.63 • n=5 Participants
|
|
Forced Expiratory Volume in 1 second % predicted
|
58.64 % predicted
STANDARD_DEVIATION 29 • n=5 Participants
|
66.85 % predicted
STANDARD_DEVIATION 24 • n=7 Participants
|
62.74 % predicted
STANDARD_DEVIATION 27 • n=5 Participants
|
|
Unscheduled office visits in past 6 mo (Yes)
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Emergency Department visit(s) in the past 6 mo (yes)
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Asthma control Questionnaire(ACQ-6)
|
1.69 units on a scale
STANDARD_DEVIATION 0.98 • n=5 Participants
|
1.83 units on a scale
STANDARD_DEVIATION 0.86 • n=7 Participants
|
1.76 units on a scale
STANDARD_DEVIATION 0.91 • n=5 Participants
|
|
Asthma quality of life (AQLQ)
|
4.66 units on a scale
STANDARD_DEVIATION 1.2 • n=5 Participants
|
4.6 units on a scale
STANDARD_DEVIATION 0.91 • n=7 Participants
|
4.63 units on a scale
STANDARD_DEVIATION 1.03 • n=5 Participants
|
|
Daily steps
|
4737.97 steps/day
STANDARD_DEVIATION 1726.55 • n=5 Participants
|
4958.94 steps/day
STANDARD_DEVIATION 2241.91 • n=7 Participants
|
4853.98 steps/day
STANDARD_DEVIATION 1991.44 • n=5 Participants
|
|
Light Physical Activity
|
576.86 minutes/day
STANDARD_DEVIATION 59.92 • n=5 Participants
|
272.77 minutes/day
STANDARD_DEVIATION 62.01 • n=7 Participants
|
274.17 minutes/day
STANDARD_DEVIATION 70.96 • n=5 Participants
|
|
Moderate Physical Activity
|
15.78 minutes/day
STANDARD_DEVIATION 18.30 • n=5 Participants
|
16.67 minutes/day
STANDARD_DEVIATION 16.56 • n=7 Participants
|
16.23 minutes/day
STANDARD_DEVIATION 16.74 • n=5 Participants
|
|
Vigorous Physical Activity
|
0.63 minutes/day
STANDARD_DEVIATION 2.48 • n=5 Participants
|
0.19 minutes/day
STANDARD_DEVIATION 0.76 • n=7 Participants
|
0.34 minutes/day
STANDARD_DEVIATION 1.70 • n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksThe total number of participants recruited and consented in the study.
Outcome measures
| Measure |
Screen Participants
n=152 Participants
This is the number of participants that were screened for eligibility in the study.
|
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.
|
|---|---|---|
|
Feasibility of Intervention-Recruitment
|
53 participants
|
—
|
PRIMARY outcome
Timeframe: 24 weeksNumber of participants that withdrew from the study
Outcome measures
| Measure |
Screen Participants
n=25 Participants
This is the number of participants that were screened for eligibility in the study.
|
Enhanced Usual Care
n=28 Participants
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.
|
|---|---|---|
|
Feasibility of Intervention-Withdrawals
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 24 weeksNumber of participants that completed 24-week outcomes assessment
Outcome measures
| Measure |
Screen Participants
n=23 Participants
This is the number of participants that were screened for eligibility in the study.
|
Enhanced Usual Care
n=26 Participants
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.
|
|---|---|---|
|
Feasibility of Lifestyle PA Intervention
|
19 Participants
|
21 Participants
|
PRIMARY outcome
Timeframe: 24-weeksPopulation: Acceptability of the intervention was measured in only intervention participants
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.
Outcome measures
| Measure |
Screen Participants
n=17 Participants
This is the number of participants that were screened for eligibility in the study.
|
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.
|
|---|---|---|
|
Acceptability of Lifestyle PA Intervention
|
6.88 units on a scale
Standard Deviation 0.33
|
—
|
PRIMARY outcome
Timeframe: 24-weeksPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 weeksPopulation: 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).
as measured by accelerometer and using proprietary Actilife software
Outcome measures
| Measure |
Screen Participants
n=16 Participants
This is the number of participants that were screened for eligibility in the study.
|
Enhanced Usual Care
n=15 Participants
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.
|
|---|---|---|
|
Light Physical Activity Levels
|
567.13 minutes per day
Standard Deviation 79.99
|
278.66 minutes per day
Standard Deviation 89.43
|
SECONDARY outcome
Timeframe: 24 weeksThe 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.
Outcome measures
| Measure |
Screen Participants
n=19 Participants
This is the number of participants that were screened for eligibility in the study.
|
Enhanced Usual Care
n=21 Participants
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.
|
|---|---|---|
|
Asthma Quality of Life Questionnaire (AQLQ)
|
5.24 score on a scale
Standard Deviation 1.35
|
4.70 score on a scale
Standard Deviation 1.06
|
SECONDARY outcome
Timeframe: 24 weeksUnabbreviated 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.
Outcome measures
| Measure |
Screen Participants
n=19 Participants
This is the number of participants that were screened for eligibility in the study.
|
Enhanced Usual Care
n=21 Participants
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.
|
|---|---|---|
|
Asthma Control Questionnaire (ACQ-6)
|
1.28 score on a scale
Standard Deviation 1.03
|
1.87 score on a scale
Standard Deviation 0.99
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: 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).
as measured by accelerometer
Outcome measures
| Measure |
Screen Participants
n=16 Participants
This is the number of participants that were screened for eligibility in the study.
|
Enhanced Usual Care
n=15 Participants
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.
|
|---|---|---|
|
Daily Step Counts
|
4372.73 steps/day
Standard Deviation 1884.90
|
5196.32 steps/day
Standard Deviation 1763.58
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: 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).
as measured by accelerometer and using proprietary Actilife software
Outcome measures
| Measure |
Screen Participants
n=16 Participants
This is the number of participants that were screened for eligibility in the study.
|
Enhanced Usual Care
n=15 Participants
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.
|
|---|---|---|
|
Moderate Physical Activity Levels
|
16.63 minutes per day
Standard Deviation 23.67
|
18.07 minutes per day
Standard Deviation 13.72
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: 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).
as measured by accelerometer and using proprietary Actilife software
Outcome measures
| Measure |
Screen Participants
n=16 Participants
This is the number of participants that were screened for eligibility in the study.
|
Enhanced Usual Care
n=15 Participants
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.
|
|---|---|---|
|
Vigorous Physical Activity Levels
|
0.37 minutes per day
Standard Deviation 1.28
|
1.14 minutes per day
Standard Deviation 3.03
|
Adverse Events
ACTION Intervention
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Enhanced Usual Care
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ACTION Intervention
n=25 participants at risk
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.
|
Enhanced Usual Care
n=28 participants at risk
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.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
skin rash
|
8.0%
2/25 • Number of events 2 • 36 weeks
|
3.6%
1/28 • Number of events 1 • 36 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place