A Phase 1/2 interventional study of Walking only (Step It Up!) and Combined (Step It Up! plus Civic Engagement) in Physical Activity, sponsored by Oregon Health and Science University. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-16.
Sponsored by Oregon Health and Science University · Phase 1/2, Interventional, and Prevention
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.
The goals of this study are:
Oregon Health and Science University is the lead sponsor of 676 studies on the registry; 136 are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 36 (73%) have results posted.
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Exclusion criteria:
A group-based, weekly walking program (Step It Up) where participants walk for up to 45 minutes.
Other: Walking only (Step It Up!)
A group-based, weekly walking program (Step It Up) where participants walk for up to 45 minutes. Participants also spend 30 minutes each week in a civic engagement program (the Change Club) improving walkability in the community
Other: Walking only (Step It Up!) · Other: Combined (Step It Up! plus Civic Engagement)
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.
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
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.
Time frame: Change from baseline physical activity at 6 months, 12 months, and 24 months.
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.
Time frame: Change from baseline cardio respiratory fitness at 6 months, 12 months, and 24 months.
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.
Time frame: Change from baseline collective efficacy at 6 months, 12 months, and 24 months
Height
Researchers will measure the height of participants in inches.
Time frame: Baseline
Hip circumference
Researchers will measure the hip circumference of participants in inches.
Time frame: Change from baseline hip circumference at 6 months, 12 months, and 24 months.
Resting heart rate
Researchers will measure resting heart rate of participants by using heart rate monitor.
Time frame: Change from baseline resting heart rate at 6 months, 12 months, and 24 months.
Weight
Researchers will measure the weight of participants in pounds.
Time frame: Change from baseline weight at 6 months, 12 months, and 24 months.
Blood pressure
Researchers will measure the both diastolic and systolic blood pressure of participants using a sphygmomanometer.
Time frame: Change from baseline blood pressure at 6 months, 12 months, and 24 months.
Plan to share: Yes — The proposed research will involve the collection of qualitative and quantitative data. The investigators will not share the qualitative data due to the potential to compromise participant identity and related ethical concerns. Quantitative data from the participants will include demographic, anthropometric, physiologic, and behavioral data. Identifiers will be removed from the final datasets prior to release for sharing. However, given the small populations of the targeted communities, data will only be made available through a data sharing agreement to prevent the possibility of identity disclosure. This agreement will ensure that the data are used for research purposes only, that it will be kept secure, and that it will be destroyed or returned following analysis completion.
This study is active, not recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Oregon Health and Science University