Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 3068 for:    Recruiting, Not yet recruiting, Available Studies | Physical

Promoting Physical Activity in Rural Populations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03683173
Recruitment Status : Recruiting
First Posted : September 25, 2018
Last Update Posted : July 17, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Ross Brownson, Washington University School of Medicine

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).

Condition or disease Intervention/treatment Phase
Physical Activity Behavioral: Intervention Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Multilevel Approaches for Promoting Physical Activity in Rural Populations
Actual Study Start Date : December 17, 2018
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Multilevel Intervention
Participants will receive the multilevel intervention consisting of community events, walking group formation, and short messaging service.
Behavioral: Intervention
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.



Primary Outcome Measures :
  1. Change in objective physical activity measured by accelerometer and global positioning device measured at baseline and 9-month follow-up [ Time Frame: The change in physical activity will be assessed between baseline and 9-month follow-up. ]
    Participants will wear an accelerometer and global positioning device to measure physical activity.

  2. Change in objective physical activity measured by accelerometer and global positioning device measured at 9-month and 18-month follow-up [ Time Frame: The change in physical activity will be assessed at 9-month and 18-month follow-up. ]
    Participants will wear an accelerometer and global positioning device to measure physical activity.


Secondary Outcome Measures :
  1. Change in subjective physical activity measured by the Global Physical Activity Questionnaire at baseline and 9-month follow-up [ Time Frame: Each participant will complete questionnaire via a telephone survey at baseline and 9-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 (e.g., work, travel, recreation). 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 (i.e., no moderate physical activity in a week) to over 150 minutes per week (i.e., meeting recommendations) for moderate physical activity, and 0 minutes per week (i.e., no vigorous physical activity in a week) to over 75 minutes per week (i.e., meeting recommendations).

  2. Change in subjective physical activity measured by the Global Physical Activity Questionnaire at 9-month and 18-month follow-up [ Time Frame: Each participant will complete questionnaire via a telephone survey at 9-month and 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 (e.g., work, travel, recreation). 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 (i.e., no moderate physical activity in a week) to over 150 minutes per week (i.e., meeting recommendations) for moderate physical activity, and 0 minutes per week (i.e., no vigorous physical activity in a week) to over 75 minutes per week (i.e., meeting recommendations).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03683173


Contacts
Layout table for location contacts
Contact: Alan M Beck, PhD 314-935-0125 alan.beck@wustl.edu

Locations
Layout table for location information
United States, Missouri
Washington University in St. Louis Recruiting
Saint Louis, Missouri, United States, 63130
Contact: Alan M Beck, PhD    314-935-0125    alan.beck@wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Ross C Brownson, PhD Washington University School of Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Ross Brownson, Professor, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03683173     History of Changes
Other Study ID Numbers: R01CA211323 ( U.S. NIH Grant/Contract )
R01CA211323 ( U.S. NIH Grant/Contract )
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ross Brownson, Washington University School of Medicine:
Physical Activity
Rural
Cancer Prevention