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Physical ActivityPhase 1/2NCT05677906

Rural Libraries Promoting Walking and Walkability in Their Rural Communities

A Phase 1/2 study testing Walking only (Step It Up!) and Combined (Step It Up! plus Civic Engagement) in people with Physical Activity, run by Oregon Health and Science University at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Physical Activity
What is being tested?
Walking only (Step It Up!) and Combined (Step It Up! plus Civic Engagement)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
331 participants
Where
1 siteUnited States
Study dates
25 Apr 2023to 31 Dec 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Oregon Health & Science University

    Portland, Oregon, 97239

Other trials in United States

About this study

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.

Read the detailed 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
Being tested
Walking only (Step It Up!), Combined (Step It Up! plus Civic Engagement)
Keywords
rural populations, physical activity promotion
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Walking only (Step It Up!)Other

    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)Other

    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

Study groups in NCT05677906
Study groupRoleWhat they receive
Walking only (Step It Up!)Active comparatorA group-based, weekly walking program (Step It Up) where participants walk for up to 45 minutes.
Receives: Other: Walking only (Step It Up!)
Combined (Step It Up! plus Change Club)ExperimentalA 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
Receives: Other: Walking only (Step It Up!); Other: Combined (Step It Up! plus Civic Engagement)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change from baseline physical activity at 6 months, 12 months, and 24 months.

  2. 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.

    Measured: Change from baseline cardio respiratory fitness at 6 months, 12 months, and 24 months.

  3. 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.

    Measured: Change from baseline collective efficacy at 6 months, 12 months, and 24 months

Secondary outcomes (5)

  1. Height

    Researchers will measure the height of participants in inches.

    Measured: Baseline

  2. Hip circumference

    Researchers will measure the hip circumference of participants in inches.

    Measured: Change from baseline hip circumference at 6 months, 12 months, and 24 months.

  3. Resting heart rate

    Researchers will measure resting heart rate of participants by using heart rate monitor.

    Measured: Change from baseline resting heart rate at 6 months, 12 months, and 24 months.

  4. Weight

    Researchers will measure the weight of participants in pounds.

    Measured: Change from baseline weight at 6 months, 12 months, and 24 months.

  5. Blood pressure

    Researchers will measure the both diastolic and systolic blood pressure of participants using a sphygmomanometer.

    Measured: Change from baseline blood pressure at 6 months, 12 months, and 24 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2023
  2. Study start25 Apr 2023
  3. Primary completion30 Sep 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
331 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05677906
Sponsor's protocol ID
STUDY00024665
Status last verified
Dec 2023
First submitted
7 Dec 2022
Last updated
16 Jan 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • 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.

    PubMed 33301392

  • 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.

    PubMed 29390863

  • Seguin-Fowler RA, Graham ML, Eldridge GD, Folta SC, Szeszulski J, MacMillan Uribe AL, Marshall GA, Villarreal DL, Volpe LC, Maddock JE, Nelson ME. Implementation of and Recommendations From the Change Club Civic Engagement Curriculum Targeting Health Behavior Improvement. Am J Health Promot. 2026 Aug 17:8901171261478393. doi: 10.1177/08901171261478393. Online ahead of print.

    PubMed 42608888

  • Perry CK, Seguin-Fowler R, Maddock JE, Lenstra N, Dieckmann NF, Currier J, Andreyeva E, Winkle J, Trost SG. Rural libraries implementing walking groups or walking groups plus civic engagement for walkability in rural communities: a comparative effectiveness trial study protocol. BMC Public Health. 2023 Oct 2;23(1):1895. doi: 10.1186/s12889-023-16788-0.

    PubMed 37784086

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Walking only (Step It Up!) and Combined (Step It Up! plus Civic Engagement) in people with Physical Activity, run by Oregon Health and Science University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical activity (time frame: Change from baseline physical activity at 6 months, 12 months, and 24 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05677906, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2024.

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