Trial Outcomes & Findings for Citizen Science to Promote Sustained Physical Activity in Low-Income Communities (NCT NCT03041415)
NCT ID: NCT03041415
Last Updated: 2022-08-12
Results Overview
Self-report using the Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire. CHAMPS is a self-report physical activity questionnaire that assesses weekly frequency and duration of various activities typically undertaken by midlife and older adults over the prior 4-week period. Self-reported walking for errands is one physical activity item assessed. The measure has been shown to have good test-retest reliability (stability) and construct and concurrent validity, and has been shown to be sensitive to change in a variety of adult populations. It has seven frequency categories (from less than 1 hour a week to 9 or more hours per week). The minimum value is 0 and the maximal value is variable.
COMPLETED
NA
300 participants
12 months
2022-08-12
Participant Flow
Participants were randomized in groups/clusters (affordable housing sites) to receive the assigned interventions.
Unit of analysis: Affordable housing sites
Participant milestones
| Measure |
ALED Alone Physical Activity (PA) Program
* The Active Living Every Day (ALED) comprehensive 12-week PA training and support program is appropriate for delivery by trained instructors from diverse backgrounds.
* Participants are taught self-regulatory skills aimed at increasing and sustaining regular physical activities such as walking.
ALED Alone Physical Activity Program: • 12-week class focused on teaching self-regulatory skills to increase regular PA
|
ALED + Our Voice PA Program
* The ALED physical activity program is combined with the Our Voice citizen science engagement program, which teaches participants how to assess the barriers and enablers of neighborhood physical activity using a simple mobile app.
* Residents then share their data and build consensus around major barriers and potential solutions, which they share with local decision makers.
ALED + Our Voice PA Program: • 12-week class focused on teaching self-regulatory skills to increase regular PA
• Neighborhood assessment, consensus-building, \& advocacy program in which participants are taught skills to promote neighborhood-level changes in support of regular Physical activity
|
|---|---|---|
|
Overall Study
STARTED
|
140 5
|
160 5
|
|
Overall Study
COMPLETED
|
123 5
|
145 5
|
|
Overall Study
NOT COMPLETED
|
17 0
|
15 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Citizen Science to Promote Sustained Physical Activity in Low-Income Communities
Baseline characteristics by cohort
| Measure |
ALED Alone Physical Activity Program
n=140 Participants
* The Active Living Every Day (ALED) comprehensive 12-week PA training and support program is appropriate for delivery by trained instructors from diverse backgrounds.
* Participants are taught self-regulatory skills aimed at increasing and sustaining regular physical activities such as walking.
ALED Alone Physical Activity Program: • 12-week class focused on teaching self-regulatory skills to increase regular PA
|
ALED + Our Voice PA Program
n=160 Participants
* The ALED physical activity program is combined with the Our Voice citizen science engagement program, which teaches participants how to assess the barriers and enablers of neighborhood physical activity using a simple mobile app.
* Residents then share their data and build consensus around major barriers and potential solutions, which they share with local decision makers.
ALED + Our Voice PA Program: • 12-week class focused on teaching self-regulatory skills to increase regular PA
• Neighborhood assessment, consensus-building, \& advocacy program in which participants are taught skills to promote neighborhood-level changes in support of regular Physical activity
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
48 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
92 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
92 Participants
n=99 Participants
|
116 Participants
n=107 Participants
|
208 Participants
n=206 Participants
|
|
Age, Continuous
|
69.04 years
STANDARD_DEVIATION 10.91 • n=99 Participants
|
69.93 years
STANDARD_DEVIATION 9.74 • n=107 Participants
|
69.52 years
STANDARD_DEVIATION 10.29 • n=206 Participants
|
|
Sex: Female, Male
Female
|
102 Participants
n=99 Participants
|
119 Participants
n=107 Participants
|
221 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
121 Participants
n=99 Participants
|
124 Participants
n=107 Participants
|
245 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
28 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
87 Participants
n=99 Participants
|
88 Participants
n=107 Participants
|
175 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
19 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
140 Participants
n=99 Participants
|
160 Participants
n=107 Participants
|
300 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Participants who completed the protocol are included in the analysis
Self-report using the Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire. CHAMPS is a self-report physical activity questionnaire that assesses weekly frequency and duration of various activities typically undertaken by midlife and older adults over the prior 4-week period. Self-reported walking for errands is one physical activity item assessed. The measure has been shown to have good test-retest reliability (stability) and construct and concurrent validity, and has been shown to be sensitive to change in a variety of adult populations. It has seven frequency categories (from less than 1 hour a week to 9 or more hours per week). The minimum value is 0 and the maximal value is variable.
Outcome measures
| Measure |
ALED Alone Physical Activity Program
n=123 Participants
* The Active Living Every Day (ALED) comprehensive 12-week PA training and support program is appropriate for delivery by trained instructors from diverse backgrounds.
* Participants are taught self-regulatory skills aimed at increasing and sustaining regular physical activities such as walking.
ALED Alone Physical Activity Program: • 12-week class focused on teaching self-regulatory skills to increase regular PA
|
ALED + Our Voice PA Program
n=145 Participants
* The ALED physical activity program is combined with the Our Voice citizen science engagement program, which teaches participants how to assess the barriers and enablers of neighborhood physical activity using a simple mobile app.
* Residents then share their data and build consensus around major barriers and potential solutions, which they share with local decision makers.
ALED + Our Voice PA Program: • 12-week class focused on teaching self-regulatory skills to increase regular PA
• Neighborhood assessment, consensus-building, \& advocacy program in which participants are taught skills to promote neighborhood-level changes in support of regular Physical activity
|
|---|---|---|
|
Weekly Walking Minutes
|
189.5 minutes/week
Standard Deviation 227.7
|
206.7 minutes/week
Standard Deviation 198.7
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Participants who completed the protocol are included in the analysis
Self-report using the Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire. CHAMPS is a self-report physical activity questionnaire that assesses weekly frequency and duration of various activities typically undertaken by midlife and older adults over the prior 4-week period. Self-reported walking for errands is one physical activity item assessed. The measure has been shown to have good test-retest reliability (stability) and construct and concurrent validity, and has been shown to be sensitive to change in a variety of adult populations. It has seven frequency categories (from less than 1 hour a week to 9 or more hours per week). The minimum value is 0 and the maximal value is variable.
Outcome measures
| Measure |
ALED Alone Physical Activity Program
n=123 Participants
* The Active Living Every Day (ALED) comprehensive 12-week PA training and support program is appropriate for delivery by trained instructors from diverse backgrounds.
* Participants are taught self-regulatory skills aimed at increasing and sustaining regular physical activities such as walking.
ALED Alone Physical Activity Program: • 12-week class focused on teaching self-regulatory skills to increase regular PA
|
ALED + Our Voice PA Program
n=145 Participants
* The ALED physical activity program is combined with the Our Voice citizen science engagement program, which teaches participants how to assess the barriers and enablers of neighborhood physical activity using a simple mobile app.
* Residents then share their data and build consensus around major barriers and potential solutions, which they share with local decision makers.
ALED + Our Voice PA Program: • 12-week class focused on teaching self-regulatory skills to increase regular PA
• Neighborhood assessment, consensus-building, \& advocacy program in which participants are taught skills to promote neighborhood-level changes in support of regular Physical activity
|
|---|---|---|
|
Total Physical Activity
|
596.2 minutes/week
Standard Deviation 443.9
|
562.0 minutes/week
Standard Deviation 389.2
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Participants who completed the protocol are included in the analysis
Self-report using the Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire, supported via accelerometer (Actigraph). CHAMPS is A self-report physical activity questionnaire that assesses weekly frequency and duration of various activities typically undertaken by midlife and older adults over the prior 4-week period. Self-reported walking for errands is one physical activity item assessed. The measure has been shown to have good test-retest reliability (stability) and construct and concurrent validity, and has been shown to be sensitive to change in a variety of adult populations. It has seven frequency categories (from less than 1 hour a week to 9 or more hours per week). The minimum value is 0 and the maximal value is variable.
Outcome measures
| Measure |
ALED Alone Physical Activity Program
n=123 Participants
* The Active Living Every Day (ALED) comprehensive 12-week PA training and support program is appropriate for delivery by trained instructors from diverse backgrounds.
* Participants are taught self-regulatory skills aimed at increasing and sustaining regular physical activities such as walking.
ALED Alone Physical Activity Program: • 12-week class focused on teaching self-regulatory skills to increase regular PA
|
ALED + Our Voice PA Program
n=145 Participants
* The ALED physical activity program is combined with the Our Voice citizen science engagement program, which teaches participants how to assess the barriers and enablers of neighborhood physical activity using a simple mobile app.
* Residents then share their data and build consensus around major barriers and potential solutions, which they share with local decision makers.
ALED + Our Voice PA Program: • 12-week class focused on teaching self-regulatory skills to increase regular PA
• Neighborhood assessment, consensus-building, \& advocacy program in which participants are taught skills to promote neighborhood-level changes in support of regular Physical activity
|
|---|---|---|
|
Moderate-to-Vigorous Physical Activity
|
117.4 minutes/week
Standard Deviation 232.6
|
108.8 minutes/week
Standard Deviation 139.4
|
Adverse Events
ALED Alone Physical Activity Program
ALED + Our Voice PA Program
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place