Trial Outcomes & Findings for Promoting Physical Activity in Rural Communities (NCT NCT03683173)
NCT ID: NCT03683173
Last Updated: 2024-01-08
Results Overview
* Participants will wear an accelerometer to measure physical activity. * The outcome measure will measure the weekly minutes of moderate to vigorous physical activity. * Physical activity was measured using the Freedson Adult cutpoint categories from 1998. Each count was measured every 60 seconds/per minute. * Sedentary: 0-99 counts per minute * Light: 100-1951 counts per minute * Moderate: 1952-5724 counts per minute * Vigorous: 5725-9498 counts per minute * Very vigorous: 9499 and up counts per minute
COMPLETED
NA
1241 participants
Baseline and 18-month follow-up
2024-01-08
Participant Flow
14 communities in southeastern Missouri were randomized to either the intervention group or the control group. Participants from these communities were consented and enrolled and the participant flow indicates the participants that started and completed the trial.
Unit of analysis: communities
Participant milestones
| Measure |
Multilevel Intervention
Participants will receive the multilevel intervention consisting of community events, walking group formation, and short messaging service.
Intervention: Participants in the intervention arm may receive community events, partake in walking groups, and receive short messaging service.
|
Control
Does not receive the multilevel intervention.
|
|---|---|---|
|
Enrolled and Completed Baseline Survey
STARTED
|
627 7
|
614 7
|
|
Enrolled and Completed Baseline Survey
COMPLETED
|
627 7
|
614 7
|
|
Enrolled and Completed Baseline Survey
NOT COMPLETED
|
0 0
|
0 0
|
|
Completed Follow-up
STARTED
|
627 7
|
614 7
|
|
Completed Follow-up
COMPLETED
|
240 7
|
238 7
|
|
Completed Follow-up
NOT COMPLETED
|
387 0
|
376 0
|
Reasons for withdrawal
| Measure |
Multilevel Intervention
Participants will receive the multilevel intervention consisting of community events, walking group formation, and short messaging service.
Intervention: Participants in the intervention arm may receive community events, partake in walking groups, and receive short messaging service.
|
Control
Does not receive the multilevel intervention.
|
|---|---|---|
|
Completed Follow-up
Unavailable
|
235
|
217
|
|
Completed Follow-up
Refused
|
69
|
59
|
|
Completed Follow-up
Disconnected phone
|
65
|
95
|
|
Completed Follow-up
Health issue/deceased
|
10
|
4
|
|
Completed Follow-up
Moved away
|
8
|
1
|
Baseline Characteristics
Promoting Physical Activity in Rural Communities
Baseline characteristics by cohort
| Measure |
Multilevel Intervention
n=627 Participants
Participants will receive the multilevel intervention consisting of community events, walking group formation, and short messaging service.
Intervention: Participants in the intervention arm may receive community events, partake in walking groups, and receive short messaging service.
|
Control
n=614 Participants
Does not receive the multilevel intervention.
|
Total
n=1241 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<=18 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Customized
Between 18 and 65 years
|
406 Participants
n=5 Participants
|
393 Participants
n=7 Participants
|
799 Participants
n=5 Participants
|
|
Age, Customized
>65 years
|
218 Participants
n=5 Participants
|
219 Participants
n=7 Participants
|
437 Participants
n=5 Participants
|
|
Age, Customized
Missing or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Man
|
202 Participants
n=5 Participants
|
197 Participants
n=7 Participants
|
399 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Woman
|
424 Participants
n=5 Participants
|
417 Participants
n=7 Participants
|
841 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Refused
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
615 Participants
n=5 Participants
|
604 Participants
n=7 Participants
|
1219 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
521 Participants
n=5 Participants
|
512 Participants
n=7 Participants
|
1033 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
81 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multi-racial
|
18 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not reported or missing
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
627 participants
n=5 Participants
|
614 participants
n=7 Participants
|
1241 participants
n=5 Participants
|
|
Household income before taxes
Less than $10,000
|
49 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Household income before taxes
$10,000 to under $15,000
|
46 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Household income before taxes
$15,000 to under $20,000
|
35 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Household income before taxes
$20,000 to under $25,000
|
43 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Household income before taxes
$25,000 to under $35,000
|
60 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Household income before taxes
$35,000 to under $50,000
|
77 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
|
Household income before taxes
$50,000 to under $75,000
|
95 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
177 Participants
n=5 Participants
|
|
Household income before taxes
$75,000 to under $100,000
|
53 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Household income before taxes
$100,000 to under $150,000
|
40 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Household income before taxes
$150,000 to under $200,000
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Household income before taxes
$200,000 or more
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Household income before taxes
Missing or Not Reported
|
104 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
186 Participants
n=5 Participants
|
|
Town
Piedmont
|
56 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Town
Doniphan
|
0 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Town
Perryville
|
81 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Town
Dexter
|
0 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Town
Poplar Bluff
|
181 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
|
Town
Sikeston
|
0 Participants
n=5 Participants
|
174 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
|
Town
Mountain View
|
31 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Town
Portageville
|
0 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Town
Kennett
|
87 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Town
West Plains
|
0 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Town
Charleston
|
75 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Town
Caruthersville
|
0 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Town
Jackson
|
116 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Town
Farmington
|
0 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Highest education level
Grades 1 - 8 (Elementary)
|
7 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Highest education level
Grades 9 - 11 (Some High School)
|
27 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Highest education level
Completed High School or GED equivalent
|
168 Participants
n=5 Participants
|
161 Participants
n=7 Participants
|
329 Participants
n=5 Participants
|
|
Highest education level
Some college or vocational program
|
124 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
252 Participants
n=5 Participants
|
|
Highest education level
Completed Associate degree (2-year program)
|
91 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
|
Highest education level
Completed Bachelors degree (4-year program)
|
137 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
253 Participants
n=5 Participants
|
|
Highest education level
Completed Masters degree
|
53 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Highest education level
Beyond Masters degree
|
20 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Highest education level
Missing or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 18-month follow-upPopulation: Only 56 participants (28 enrolled in the Multilevel Intervention Arm and 28 enrolled in the Control Arm) had valid data at baseline and at the 18-month follow-up.
* Participants will wear an accelerometer to measure physical activity. * The outcome measure will measure the weekly minutes of moderate to vigorous physical activity. * Physical activity was measured using the Freedson Adult cutpoint categories from 1998. Each count was measured every 60 seconds/per minute. * Sedentary: 0-99 counts per minute * Light: 100-1951 counts per minute * Moderate: 1952-5724 counts per minute * Vigorous: 5725-9498 counts per minute * Very vigorous: 9499 and up counts per minute
Outcome measures
| Measure |
Multilevel Intervention
n=28 Participants
Participants will receive the multilevel intervention consisting of community events, walking group formation, and short messaging service.
Intervention: Participants in the intervention arm may receive community events, partake in walking groups, and receive short messaging service.
|
Control
n=28 Participants
Does not receive the multilevel intervention.
|
|---|---|---|
|
Change in Objective Physical Activity Measured by Accelerometer Measured at Baseline and 18-month Follow-up
Baseline
|
63.46 minutes per week
Standard Deviation 84.58
|
96.94 minutes per week
Standard Deviation 85.32
|
|
Change in Objective Physical Activity Measured by Accelerometer Measured at Baseline and 18-month Follow-up
18-month follow-up
|
74.02 minutes per week
Standard Deviation 97.63
|
76.13 minutes per week
Standard Deviation 72.79
|
SECONDARY outcome
Timeframe: Baseline and 18-month follow-up.Population: The number of participants analyzed includes only those who completed the questionnaire at the indicated time point.
* Will use the Global Physical Activity Questionnaire to determine the number of participants who met the physical activity recommendations at baseline and at the 18-month follow-up. * The Global Physical Activity Questionnaire measures time spent in vigorous and moderate intensity physical activity in the domains of work, travel, and recreation. Participants will answer yes or no to their involvement in a given intensity (e.g., vigorous or moderate) in a given domain. If the participant answers 'yes' they will be asked on how many days do they partake in the activity, and for how many hours and/or minutes do they partake in the activity. A higher score equates to more physical activity. The range is from 0 minutes per week (no moderate physical activity in a week) to over 150 minutes per week (meeting recommendations) for moderate physical activity, and 0 minutes per week (no vigorous physical activity in a week) to over 75 minutes per week (meeting recommendations).
Outcome measures
| Measure |
Multilevel Intervention
n=606 Participants
Participants will receive the multilevel intervention consisting of community events, walking group formation, and short messaging service.
Intervention: Participants in the intervention arm may receive community events, partake in walking groups, and receive short messaging service.
|
Control
n=596 Participants
Does not receive the multilevel intervention.
|
|---|---|---|
|
Number of Participants Who Met the Subjective Physical Activity Recommendations as Measured by the Global Physical Activity Questionnaire at Baseline and 18-month Follow-up
Baseline
|
292 Participants
|
287 Participants
|
|
Number of Participants Who Met the Subjective Physical Activity Recommendations as Measured by the Global Physical Activity Questionnaire at Baseline and 18-month Follow-up
18-month follow-up
|
118 Participants
|
102 Participants
|
Adverse Events
Multilevel Intervention
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Diana Parra Perez, Ph.D.
Washington University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place