Physical Activity
Conditions
Keywords
Physical Activity, Rural, Cancer Prevention
Brief summary
The purpose of the study is to test a multilevel intervention's impact on increasing physical activity among rural residents. It is expected that participants who participate in more of the intervention (e.g., all levels) will increase their physical activity more than the control group and individuals who participate in less of the intervention (e.g., one level of the intervention).
Detailed description
The study will test the independent and moderating effects of a multilevel intervention and the community environment on physical activity among rural residents. The multilevel intervention consists of community, interpersonal, and intrapersonal aspects. The community level intervention consists of community events. The interpersonal level intervention consists of walking group formation. The intrapersonal level intervention consists of cues provided by short message service messages (i.e., text messaging). A dose response relationship is expected in the intervention communities.
Interventions
BEHAVIORALIntervention
Participants in the intervention arm may receive community events, partake in walking groups, and receive short messaging service.
Sponsors
National Cancer Institute (NCI)
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults (18+) * No cognitive impairments * Able to physically active * Willing to complete telephone survey at three time points * Located in targeted communities in southeast Missouri
Exclusion criteria
* Participants not located in targeted communities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Objective Physical Activity Measured by Accelerometer Measured at Baseline and 18-month Follow-up | Baseline and 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 and 18-month follow-up. | * 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). |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 627 |
| Control Does not receive the multilevel intervention. | 614 |
| Total | 1,241 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Completed Follow-up | Disconnected phone | 65 | 95 |
| Completed Follow-up | Health issue/deceased | 10 | 4 |
| Completed Follow-up | Moved away | 8 | 1 |
| Completed Follow-up | Refused | 69 | 59 |
| Completed Follow-up | Unavailable | 235 | 217 |
Baseline characteristics
| Characteristic | Control | Total | Multilevel Intervention |
|---|---|---|---|
| Age, Customized <=18 years | 1 Participants | 2 Participants | 1 Participants |
| Age, Customized >65 years | 219 Participants | 437 Participants | 218 Participants |
| Age, Customized Between 18 and 65 years | 393 Participants | 799 Participants | 406 Participants |
| Age, Customized Missing or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 20 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 604 Participants | 1219 Participants | 615 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Highest education level Beyond Masters degree | 27 Participants | 47 Participants | 20 Participants |
| Highest education level Completed Associate degree (2-year program) | 69 Participants | 160 Participants | 91 Participants |
| Highest education level Completed Bachelors degree (4-year program) | 116 Participants | 253 Participants | 137 Participants |
| Highest education level Completed High School or GED equivalent | 161 Participants | 329 Participants | 168 Participants |
| Highest education level Completed Masters degree | 59 Participants | 112 Participants | 53 Participants |
| Highest education level Grades 1 - 8 (Elementary) | 15 Participants | 22 Participants | 7 Participants |
| Highest education level Grades 9 - 11 (Some High School) | 37 Participants | 64 Participants | 27 Participants |
| Highest education level Missing or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Highest education level Some college or vocational program | 128 Participants | 252 Participants | 124 Participants |
| Household income before taxes $100,000 to under $150,000 | 45 Participants | 85 Participants | 40 Participants |
| Household income before taxes $10,000 to under $15,000 | 48 Participants | 94 Participants | 46 Participants |
| Household income before taxes $150,000 to under $200,000 | 5 Participants | 14 Participants | 9 Participants |
| Household income before taxes $15,000 to under $20,000 | 45 Participants | 80 Participants | 35 Participants |
| Household income before taxes $200,000 or more | 14 Participants | 30 Participants | 16 Participants |
| Household income before taxes $20,000 to under $25,000 | 36 Participants | 79 Participants | 43 Participants |
| Household income before taxes $25,000 to under $35,000 | 55 Participants | 115 Participants | 60 Participants |
| Household income before taxes $35,000 to under $50,000 | 78 Participants | 155 Participants | 77 Participants |
| Household income before taxes $50,000 to under $75,000 | 82 Participants | 177 Participants | 95 Participants |
| Household income before taxes $75,000 to under $100,000 | 71 Participants | 124 Participants | 53 Participants |
| Household income before taxes Less than $10,000 | 53 Participants | 102 Participants | 49 Participants |
| Household income before taxes Missing or Not Reported | 82 Participants | 186 Participants | 104 Participants |
| Race/Ethnicity, Customized American Indian/Alaska Native | 7 Participants | 10 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian or Pacific Islander | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 78 Participants | 159 Participants | 81 Participants |
| Race/Ethnicity, Customized Multi-racial | 10 Participants | 28 Participants | 18 Participants |
| Race/Ethnicity, Customized Not reported or missing | 7 Participants | 9 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 512 Participants | 1033 Participants | 521 Participants |
| Region of Enrollment United States | 614 participants | 1241 participants | 627 participants |
| Sex/Gender, Customized Man | 197 Participants | 399 Participants | 202 Participants |
| Sex/Gender, Customized Refused | 0 Participants | 1 Participants | 1 Participants |
| Sex/Gender, Customized Woman | 417 Participants | 841 Participants | 424 Participants |
| Town Caruthersville | 61 Participants | 61 Participants | 0 Participants |
| Town Charleston | 0 Participants | 75 Participants | 75 Participants |
| Town Dexter | 56 Participants | 56 Participants | 0 Participants |
| Town Doniphan | 93 Participants | 93 Participants | 0 Participants |
| Town Farmington | 76 Participants | 76 Participants | 0 Participants |
| Town Jackson | 0 Participants | 116 Participants | 116 Participants |
| Town Kennett | 0 Participants | 87 Participants | 87 Participants |
| Town Mountain View | 0 Participants | 31 Participants | 31 Participants |
| Town Perryville | 0 Participants | 81 Participants | 81 Participants |
| Town Piedmont | 0 Participants | 56 Participants | 56 Participants |
| Town Poplar Bluff | 0 Participants | 181 Participants | 181 Participants |
| Town Portageville | 30 Participants | 30 Participants | 0 Participants |
| Town Sikeston | 174 Participants | 174 Participants | 0 Participants |
| Town West Plains | 124 Participants | 124 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 627 | 4 / 614 |
| other Total, other adverse events | 0 / 627 | 0 / 614 |
| serious Total, serious adverse events | 0 / 627 | 0 / 614 |
Outcome results
Primary
Change in Objective Physical Activity Measured by Accelerometer Measured at Baseline and 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
Time frame: Baseline and 18-month follow-up
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 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 |
| Multilevel Intervention | 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 |
| Control | Change in Objective Physical Activity Measured by Accelerometer Measured at Baseline and 18-month Follow-up | Baseline | 96.94 minutes per week | Standard Deviation 85.32 |
| Control | Change in Objective Physical Activity Measured by Accelerometer Measured at Baseline and 18-month Follow-up | 18-month follow-up | 76.13 minutes per week | Standard Deviation 72.79 |
Secondary
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
* 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).
Time frame: Baseline and 18-month follow-up.
Population: The number of participants analyzed includes only those who completed the questionnaire at the indicated time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 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 |
| 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 | 18-month follow-up | 118 Participants |
| Control | 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 | 287 Participants |
| Control | 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 | 102 Participants |