NCT05677906

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
331

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2023

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 10, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

April 25, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 16, 2024

Status Verified

December 1, 2023

Enrollment Period

2.4 years

First QC Date

December 7, 2022

Last Update Submit

January 11, 2024

Conditions

Keywords

rural populationsphysical activity promotion

Outcome Measures

Primary Outcomes (3)

  • 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.

  • 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.

  • 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 Outcomes (5)

  • Height

    Baseline

  • Hip circumference

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

  • Resting heart rate

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

  • Weight

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

  • Blood pressure

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

Study Arms (2)

Walking only (Step It Up!)

ACTIVE COMPARATOR

A group-based, weekly walking program (Step It Up) where participants walk for up to 45 minutes.

Other: Walking only (Step It Up!)

Combined (Step It Up! plus Change Club)

EXPERIMENTAL

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)

Interventions

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 Change Club)Walking only (Step It Up!)

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

Combined (Step It Up! plus Change Club)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (4)

  • 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.

    BACKGROUND
  • 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.

    PMID: 33301392BACKGROUND
  • 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.

    PMID: 29390863BACKGROUND
  • 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.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Cynthia K Perry, PhD

    Oregon Health & Science University School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2022

First Posted

January 10, 2023

Study Start

April 25, 2023

Primary Completion

September 30, 2025

Study Completion

December 31, 2025

Last Updated

January 16, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will share

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.

Time Frame
Data will become available once all manuscripts have been published.
Access Criteria
Data will be made available through a data sharing agreement.

Locations