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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03683173
Other study ID # R01CA211323
Secondary ID R01CA211323
Status Completed
Phase N/A
First received
Last updated
Start date December 17, 2018
Est. completion date December 24, 2022

Study information

Verified date January 2024
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 in less of the intervention (e.g., one level of the intervention).


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.


Recruitment information / eligibility

Status Completed
Enrollment 1241
Est. completion date December 24, 2022
Est. primary completion date December 24, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Intervention
Participants in the intervention arm may receive community events, partake in walking groups, and receive short messaging service.

Locations

Country Name City State
United States Washington University in St. Louis Saint Louis Missouri

Sponsors (2)

Lead Sponsor Collaborator
Washington University School of Medicine National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
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
Baseline and 18-month follow-up
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).
Baseline and 18-month follow-up.
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