Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01CA211323 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multilevel Intervention | Experimental | Participants will receive the multilevel intervention consisting of community events, walking group formation, and short messaging service. |
|
| Control | No Intervention | Does not receive the multilevel intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention | Behavioral | Participants in the intervention arm may receive community events, partake in walking groups, and receive short messaging service. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Objective Physical Activity Measured by Accelerometer Measured at Baseline and 18-month Follow-up |
| Baseline and 18-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ross C Brownson, PhD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University in St. Louis | St Louis | Missouri | 63130 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40951381 | Derived | Beck AM, Serrano N, Duncan D, Eyler AA, Gilbert A, Naghiloo F, Reis R, Tabak RG, Brownson RC. Cluster randomized multilevel intervention for promoting physical activity in rural communities. Front Public Health. 2025 Aug 29;13:1577056. doi: 10.3389/fpubh.2025.1577056. eCollection 2025. | |
| 36268648 | Derived | Serrano N, Beck A, Salvo D, Eyler A, Reis R, Steensma JT, Gilbert A, Brownson RC. Examining the Associations of and Interactions Between Intrapersonal and Perceived Environmental Factors With Objectively Assessed Physical Activity Among Rural Midwestern Adults, USA. Am J Health Promot. 2023 May;37(4):511-515. doi: 10.1177/08901171221134797. Epub 2022 Oct 21. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Control | Does not receive the multilevel intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrolled and Completed Baseline Survey |
| |||||||||||||
| Completed Follow-up |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 | Change in Objective Physical Activity Measured by Accelerometer Measured at Baseline and 18-month Follow-up |
| 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. | Posted | Mean | Standard Deviation | minutes per week | Baseline and 18-month follow-up |
|
Adverse events were followed from start of intervention or control through completion of 18-month follow-up.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Diana Parra Perez, Ph.D. | Washington University School of Medicine | 314-286-1426 | parrad@wustl.edu |
Not provided
| 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 | Oct 26, 2023 | Oct 26, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline and 18-month follow-up. |
| 35272263 | Derived | Gilbert A, Beck A, Serrano N, Brownson RC. Objective Measures of Physical Activity in Rural Communities: Factors Associated With a Valid Wear and Lessons Learned. J Phys Act Health. 2022 Apr 1;19(4):267-274. doi: 10.1123/jpah.2021-0677. Epub 2022 Mar 10. |
| 30700262 | Derived | Beck AM, Eyler AA, Aaron Hipp J, King AC, Tabak RG, Yan Y, Reis RS, Duncan DD, Gilbert AS, Serrano NH, Brownson RC. A multilevel approach for promoting physical activity in rural communities: a cluster randomized controlled trial. BMC Public Health. 2019 Jan 30;19(1):126. doi: 10.1186/s12889-019-6443-8. |
| NOT COMPLETED |
|
|
| Control |
Does not receive the multilevel intervention. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | This data is based on a question to the participant that asked "With what gender do you identify?" | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Household income before taxes | Count of Participants | Participants |
|
| Town | Town that the participant reported living at the time of enrollment. | Count of Participants | Participants |
|
| Highest education level | Count of Participants | 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.
| OG001 | Control | Does not receive the multilevel intervention. |
|
|
| 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 |
| The number of participants analyzed includes only those who completed the questionnaire at the indicated time point. | Posted | Count of Participants | Participants | Baseline and 18-month follow-up. |
|
|
|
| 5 |
| 627 |
| 0 |
| 627 |
| 0 |
| 627 |
| EG001 | Control | Does not receive the multilevel intervention. | 4 | 614 | 0 | 614 | 0 | 614 |
Not provided
Not provided
Not provided
| 18-month follow-up |
|
|