- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03683173
Promoting Physical Activity in Rural Communities
January 5, 2024 updated by: Ross Brownson, Washington University School of Medicine
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).
Study Overview
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 Type
Interventional
Enrollment (Actual)
1241
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63130
- Washington University in St. Louis
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Multilevel Intervention
Participants will receive the multilevel intervention consisting of community events, walking group formation, and short messaging service.
|
Participants in the intervention arm may receive community events, partake in walking groups, and receive short messaging service.
|
No Intervention: Control
Does not receive the multilevel intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Objective Physical Activity Measured by Accelerometer Measured at Baseline and 18-month Follow-up
Time Frame: Baseline and 18-month follow-up
|
|
Baseline and 18-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
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
Time Frame: Baseline and 18-month follow-up.
|
|
Baseline and 18-month follow-up.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Ross C Brownson, PhD, Washington University School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 17, 2018
Primary Completion (Actual)
December 24, 2022
Study Completion (Actual)
December 24, 2022
Study Registration Dates
First Submitted
September 18, 2018
First Submitted That Met QC Criteria
September 20, 2018
First Posted (Actual)
September 25, 2018
Study Record Updates
Last Update Posted (Estimated)
January 8, 2024
Last Update Submitted That Met QC Criteria
January 5, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- R01CA211323 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Physical Activity
-
Istinye UniversityCompletedPhysical Activity | Youth | Physical Activity Barriers | Physical Activity FacilitatorsTurkey
-
Istanbul Kültür UniversityWithdrawnPhysical Activity Level | Physical Activity Awareness
-
Georgetown UniversityUniversity of PennsylvaniaCompletedPhysical Activity | Motor ActivityUnited States
-
Assistance Publique - Hôpitaux de ParisTerminatedPhysical Activity | Physical DisabilityFrance
-
University of Colorado, DenverCompletedPhysical Activity | Physical ImpairmentUnited States
-
PXL University CollegeHasselt UniversityNot yet recruitingPhysical Activity - Digital Phenotyping - Activity Tracking
-
University of ExtremaduraThe Spanish Ministry of Science, Innovation and UniversitiesRecruitingPhysical Activity | Cognition | Physical Fitness | AdolescentsSpain
-
AdventHealth Translational Research InstituteWake Forest UniversityRecruiting
-
Wake Forest University Health SciencesMayo Clinic; National Institute of Diabetes and Digestive and Kidney Diseases... and other collaboratorsRecruitingPhysical ActivityUnited States
-
Wake Forest University Health SciencesMayo Clinic; National Institute of Diabetes and Digestive and Kidney Diseases... and other collaboratorsRecruiting
Clinical Trials on Intervention
-
Biolux Research Holdings, Inc.TerminatedOrthodontic Tooth MovementCanada
-
University of California, San FranciscoNational Cancer Institute (NCI)CompletedColorectal Carcinoma | Healthy Subject | Health Status UnknownUnited States
-
University of FloridaCompletedSensitivityUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI); National Institute on Minority Health and...RecruitingHuman Papillomavirus InfectionUnited States
-
Ohio State University Comprehensive Cancer CenterCompleted
-
Mayo ClinicNational Cancer Institute (NCI)WithdrawnCancer Survivor | Peripheral Sensory Neuropathy
-
Nottingham Trent UniversityUnknownOverweight and ObesityUnited Kingdom
-
OHSU Knight Cancer InstituteOregon Health and Science UniversityRecruitingAnatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage IA Breast Cancer AJCC v8 | Anatomic Stage IB Breast Cancer AJCC v8 | Anatomic Stage II Breast Cancer AJCC v8 | Anatomic Stage IIA Breast Cancer AJCC v8 | Anatomic Stage IIB Breast Cancer AJCC v8 | Anatomic Stage IIIA Breast Cancer AJCC v8 | Prognostic... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...American Cancer Society, Inc.Completed
-
Vanderbilt UniversityAgency for Healthcare Research and Quality (AHRQ)Completed