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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05677906
Other study ID # STUDY00024665
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date April 25, 2023
Est. completion date December 31, 2025

Study information

Verified date December 2023
Source Oregon Health and Science University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators will randomize 20 rural libraries to implement either a group-based walking (standard approach) or a group-based walking combined with a civic engagement program (combined approach). Each rural library will enroll between 15-20 participants. The investigators will compare the change in physical activity between participants in each group.


Description:

The goals of this study are: 1. Increase the capacity of rural libraries to deliver evidence-based health promotion programs 2. Compare the effects of a group-based walking program with a combined group-based plus civic engagement program on physical activity, cardiovascular fitness and collective efficacy among rural residents. 3. Evaluate program implementation


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 331
Est. completion date December 31, 2025
Est. primary completion date September 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age 18 or older - Inactive (defined as engaging in physical activity <3 days per week) - Ability to walk for at least 20 minutes - Living within the rural community served by the local library - Ability to travel to the local library/location of walking group. Exclusion criteria: - Participation/intention to participate in other lifestyle modification pro-gram(s) - Cognitive impairment - Inability to communicate due to severe uncorrected hearing loss or speech disorder or severe visual impairment (if precludes completion of assessments and/or intervention)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Walking only (Step It Up!)
Participants will meet weekly for 60 minutes and walk together as a group. Participants will progressively build up to walking for 45 minutes at a brisk pace. Walks will start with a check-in and end with stretching as a group.
Combined (Step It Up! plus Civic Engagement)
Participants in the combined groups will meet weekly for 90 minutes with group members. They will participate in a group walk for 60 minutes followed by 30 minutes of civic engagement aimed at improving walkability in the community

Locations

Country Name City State
United States Oregon Health & Science University Portland Oregon

Sponsors (3)

Lead Sponsor Collaborator
Oregon Health and Science University Texas A&M University, University of North Carolina, Greensboro

Country where clinical trial is conducted

United States, 

References & Publications (3)

Lenstra N. The role of public librarians in supporting physical activity: challenging the "Jacks of All Trades but Masters of None" librarian syndrome. Advances in Library Administration and Organization. 2018;39:185-205.

Perry CK, Campbell LP, Currier J, Farris PE, Wenzel ES, Medysky ME, Zell A, McDonell M, Shannon J, Winters-Stone K. An Evidence-Based Walking Program in Oregon Communities: Step It Up! Survivors. Prev Chronic Dis. 2020 Dec 10;17:E156. doi: 10.5888/pcd17.200231. — View Citation

Seguin RA, Sriram U, Connor LM, Silver AE, Niu B, Bartholomew AN. A Civic Engagement Approach to Encourage Healthy Eating and Active Living in Rural Towns: The HEART Club Pilot Project. Am J Health Promot. 2018 Sep;32(7):1591-1601. doi: 10.1177/0890117117748122. Epub 2018 Feb 1. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Physical activity Participants will be asked to wear an accelerometer for >10 hours/day for seven days at the wrist to measure physical activity. An accelerometer is a small device worn at the wrist that records acceleration, the change in velocity of a participant over time. Change from baseline physical activity at 6 months, 12 months, and 24 months.
Primary Cardio respiratory fitness Participants will be asked to complete a six-minute walk test to measure cardiorespiratory fitness. The distance walked in 6 minutes will be recorded. Change from baseline cardio respiratory fitness at 6 months, 12 months, and 24 months.
Primary Collective Efficacy Participants will be asked to complete a survey regarding collective-efficacy, the Collective Efficacy Scale (Sampson and colleagues, 1997), which measures how well communities work together to make things happen. Change from baseline collective efficacy at 6 months, 12 months, and 24 months
Secondary Height Researchers will measure the height of participants in inches. Baseline
Secondary Hip circumference Researchers will measure the hip circumference of participants in inches. Change from baseline hip circumference at 6 months, 12 months, and 24 months.
Secondary Resting heart rate Researchers will measure resting heart rate of participants by using heart rate monitor. Change from baseline resting heart rate at 6 months, 12 months, and 24 months.
Secondary Weight Researchers will measure the weight of participants in pounds. Change from baseline weight at 6 months, 12 months, and 24 months.
Secondary Blood pressure Researchers will measure the both diastolic and systolic blood pressure of participants using a sphygmomanometer. Change from baseline blood pressure at 6 months, 12 months, and 24 months.
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