Rural Libraries Promoting Walking and Walkability in Their Rural Communities

January 11, 2024 updated by: Oregon Health and Science University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
331

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Walking only (Step It Up!)
A group-based, weekly walking program (Step It Up) where participants walk for up to 45 minutes.
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.
Experimental: Combined (Step It Up! plus Change Club)
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!)
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.
Other: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Physical activity
Time Frame: Change from baseline physical activity at 6 months, 12 months, and 24 months.
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.
Cardio respiratory fitness
Time Frame: Change from baseline cardio respiratory fitness at 6 months, 12 months, and 24 months.
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.
Collective Efficacy
Time Frame: Change from baseline collective efficacy at 6 months, 12 months, and 24 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Height
Time Frame: Baseline
Researchers will measure the height of participants in inches.
Baseline
Hip circumference
Time Frame: Change from baseline hip circumference at 6 months, 12 months, and 24 months.
Researchers will measure the hip circumference of participants in inches.
Change from baseline hip circumference at 6 months, 12 months, and 24 months.
Resting heart rate
Time Frame: Change from baseline resting heart rate at 6 months, 12 months, and 24 months.
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.
Weight
Time Frame: Change from baseline weight at 6 months, 12 months, and 24 months.
Researchers will measure the weight of participants in pounds.
Change from baseline weight at 6 months, 12 months, and 24 months.
Blood pressure
Time Frame: Change from baseline blood pressure at 6 months, 12 months, and 24 months.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oregon Health and Science University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Texas A&M University
University of North Carolina, Greensboro

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cynthia K Perry, PhD, Oregon Health & Science University School of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 25, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 28, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00024665

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data will become available once all manuscripts have been published.

IPD Sharing Access Criteria

Data will be made available through a data sharing agreement.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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