Walk On! National Council on Aging Innovation Lab

NCT07368907 | Recruiting

• 2 other identifiers: IRB0013800290ACIL0001
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-site, one-arm type-2 hybrid-effectiveness implementation trial. The goal of this clinical trial is to learn if the Walk On! program helps prevent falls in older adults who have trouble moving around or feel socially isolated. Researchers want to know:

1. 1.What are the best ways for organizations to offer the Walk On! program and keep it running for older adults in their community?
2. 2.Does Walk On! help prevent falls in older adults?
3. 3.Join group walking sessions led by a trained facilitator
4. 4.Meet twice a week for 12 weeks (24 sessions)
5. 5.Take part in simple tests before and after the program to see if there are any changes in older adults' function, confidence in not falling, or loneliness.

Conditions

Falls Prevention

Keywords

Mobility Limitation; Implementation Science; Community-based

Outcome Measures

Primary Outcomes (5)

• Adoption of Program

  Number of community-based organizations that deliver of one full 12-week round of Walk On! to a minimum of 8 participants who have not previously participated in the program. Data Source: community-based organization's site attendance records.

  Week 12

• Fall Incidence

  Number of falls in past 12 weeks (3 months), including number of injurious falls. Data Source(s): Self-report, pre- and post-program assessment surveys. Number of Survey Items: 2. Total Score range: open-ended, 0 to no upper limit (higher score indicates more falls).

  baseline

• Fall Incidence

  Number of falls in past 12 weeks (3 months), including number of injurious falls. Data Source(s): Self-report, pre- and post-program assessment surveys. Number of Survey Items: 2. Total Score range: open-ended, 0 to no upper limit (higher score indicates more falls).

  week 12

• Fall self-efficacy

  Confidence in performing daily activities without falling; fear of falling Data Source(s): Self-report, pre- and post-program assessments (Confidence in performing daily activities without falling; fear of falling) Number of Survey Items: 11 Total Score range: 11 to 44 (higher score indicates more confidence in performing daily activities without falling; less fear of falling)

  baseline

• Fall self-efficacy

  Confidence in performing daily activities without falling; fear of falling. Data Source(s): Self-report, pre- and post-program assessments (Confidence in performing daily activities without falling; fear of falling). Number of Survey Items: 11. Total Score range: 11 to 44 (higher score indicates more confidence in performing daily activities without falling; less fear of falling).

  week 12

Secondary Outcomes (2)

• Loneliness

  baseline, week 12

• Mobility

  baseline, week 12

Other Outcomes (1)

• Sustainment of Program

  week 36

Study Arms (1)

Walk On! Program

EXPERIMENTAL

This study uses a single-group model in which all participating Community-Based Organizations (CBOs) receive the same implementation support for Walk On! intervention adoption and delivery. All older adult participants enrolled will receive the intervention. All activities will be unblinded. Intervention participants will be older adults, including those with mobility limitations, recruited from the local community. All intervention activities will take place in person within a community setting. The intervention will focus on improving walking endurance, strength, and balance. The intervention will be delivered by trained facilitators based at CBOs. All facilitators will receive comprehensive training and implementation support as part of this study.

Behavioral: Walk On! Program

Interventions

Walk On! Program BEHAVIORAL

24 sessions (twice weekly for 60 minutes over 12 weeks) with a focus on improving walking endurance, strength, and balance in older adults, including those with mobility limitations. All intervention activities will take place in person within a community setting. The intervention will be delivered by trained facilitators based at community-based organizations. All facilitators will receive comprehensive training and implementation support as part of this study.

Walk On! Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than or equal to 60 years
• Able to provide own transportation to the program each week
• No planned extended travel or time away during the 12 week program period
• English speaking with intact verbal and written communication skills
• Free of current fracture
• Able to ambulate independently, with or without an assistive device (i.e., cane or walker)

You may not qualify if:

• Serious or unstable medical or psychiatric condition that would prevent participation in research study
• Lack of decision-making capacity
• Participated in an evidence-based falls prevention program within the past 12 months
• Age greater than or equal to 18 years
• English speaking
• Not interested in offering a Walk On! program
• Unwilling and/or unable to participate in implementation activities

Sponsors & Collaborators

• National Council on Aging (NCOA): collaborator
• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27101, United States

RECRUITING

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jaime M Hughes, MSW, MPH, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaime M Hughes, MSW, MPH, PhD

CONTACT

336-716-0835; jaime.hughes@wfusm.edu

Laura W Jakiela, MS

CONTACT

336-716-3168; laura.jakiela@advocatehealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study uses a single-group interventional model in which all participating Community-Based Organizations (CBOs) receive the same implementation support to promote program adoption. All older adult participants enrolled will receive the intervention. All activities will be unblinded. All intervention activities will take place in person within a community setting. Intervention participants will be older adults, including those with mobility limitations, recruited from the local community. The intervention will focus on improving walking endurance, strength, and balance. The intervention will be delivered by trained facilitators based at CBOs. All facilitators will receive comprehensive training and implementation support as part of this study.

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: January 27, 2026
• Study Start: April 6, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)