Physical ActivityNCT03683173
Promoting Physical Activity in Rural Communities
A study testing Intervention in people with Physical Activity, run by Washington University School of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,241 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2018to 24 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participants not located in targeted communities
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St. Louis
St Louis, Missouri, 63130
About this study
Official title: Multilevel Approaches for Promoting Physical Activity in Rural Communities
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).
Read the 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.
- Conditions
- Physical Activity
- Being tested
- Intervention
- Keywords
- Physical Activity, Rural, Cancer Prevention
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
Participants in the intervention arm may receive community events, partake in walking groups, and receive short messaging service.
| Study group | Role | What they receive |
|---|---|---|
| Multilevel Intervention | Experimental | Participants will receive the multilevel intervention consisting of community events, walking group formation, and short messaging service. Receives: Behavioral: Intervention |
| Control | No intervention | Does not receive the multilevel intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and 18-month follow-up
Secondary outcomes (1)
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).
Measured: Baseline and 18-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start17 Dec 2018
- Primary completion24 Dec 2022
- Study completion24 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Ross Brownson, Washington University School of Medicine
- Investigators
- Ross C Brownson, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03683173
- Sponsor's protocol ID
- R01CA211323
- Other IDs
- R01CA211323
- Status last verified
- Jan 2024
- First submitted
- 18 Sep 2018
- Last updated
- 8 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40951381Serrano 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.
PubMed 36268648Gilbert 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.
PubMed 35272263Beck 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.
PubMed 30700262
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multilevel Approaches for Promoting Physical Activity in Rural Communities
- ClinicalTrials.gov ID
- NCT03683173
- Acronym / sponsor ID
- R01CA211323
- Conditions
- Physical Activity
- Keywords
- Physical Activity, Rural, Cancer Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,241 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- 24 Dec 2022 (actual)
- Study completion
- 24 Dec 2022 (actual)
- First posted
- 25 Sep 2018 (actual)
- Results
- Posted 8 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multilevel Intervention | Experimental | Behavioral: InterventionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Participants not located in targeted communities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionParticipants in the intervention arm may receive community events, partake in walking groups, and receive short messaging service. | Behavioural | Multilevel Intervention |
Primary outcome
Change in Objective Physical Activity Measured by Accelerometer Measured at Baseline and 18-month Follow-up
Time frame: 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
1 secondary outcome
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
Time frame: Baseline and 18-month follow-up.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40951381Beck 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.
- Derived from this study: PubMed 36268648Serrano 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.
- Derived from this study: PubMed 35272263Gilbert 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.
- Derived from this study: PubMed 30700262Beck 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ross C Brownson, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Physical Activity, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Objective Physical Activity Measured by Accelerometer Measured at Baseline and 18-month Follow-up (time frame: Baseline and 18-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03683173, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2024.