NCT05008159

Brief Summary

Physical mobility and social participation are needed to maintain independence and quality of life for adults over 55 years of age. Despite the known benefits of physical activity and dietary change programs for older adults, the best ways to deliver these interventions are not well understood. The goal of the EMBOLDEN study is to promote physical and community mobility in older adults who experience difficulties taking up community programs and reside in areas of high health inequity. Building on existing best practices, the investigators will implement and evaluate an innovative co-designed community-based program to promote physical activity, healthy eating, social participation, and system navigation. The potential for spreading this program throughout Hamilton and adapted to other Canadian communities will also be explored

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 17, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

May 27, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

May 3, 2024

Status Verified

May 1, 2024

Enrollment Period

2.8 years

First QC Date

July 29, 2021

Last Update Submit

May 1, 2024

Conditions

Mobility LimitationHealth Related Quality of LifeHealthy AgingHealth Inequity

Keywords

Physical MobilityAgingCommunity-based interventionPublic and community engagementPhysical activityHealthy eatingSocial participationSystem navigationLife-spaceCommunity mobilityCommunity integration

Outcome Measures

Primary Outcomes (1)

  • Physical mobility

    Change in total weekly minutes spent in light, moderate-to-vigorous physical activity and sedentary activity as measured by an accelerometer worn over 7-day periods.

    Between baseline and 3-months. An additional comparison will be made at 6-months to examine whether potential changes are maintained in the post-intervention phase.

Secondary Outcomes (12)

  • Community mobility

    Between baseline and 3-months. An additional comparison will be made at 6-months to examine whether potential changes are maintained in the post-intervention phase.

  • Life Space mobility

    Between baseline and 3-months. An additional comparison will be made at 6-months to examine whether potential changes are maintained in the post-intervention phase.

  • Physical activity

    Between baseline and 3-months. An additional comparison will be made at 6-months to examine whether potential changes are maintained in the post-intervention phase.

  • Healthy eating and nutritional risk

    Between baseline and 3-months. An additional comparison will be made at 6-months to examine whether potential changes are maintained in the post-intervention phase.

  • Health-related quality of life

    Between baseline and 3-months. An additional comparison will be made at 6-months to examine whether potential changes are maintained in the post-intervention phase.

  • +7 more secondary outcomes

Study Arms (2)

The EMBOLDEN program

EXPERIMENTAL

3 month community-based mobility and healthy aging intervention

Behavioral: 3 month community-based mobility and health intervention

Usual care

NO INTERVENTION

Interventions

3 month community-based mobility and health interventionBEHAVIORAL

12 weekly GROUP (10-15 adults per cohort) sessions + 3 INDIVIDUAL tailored system navigation sessions at beginning, midpoint, and end of program. The 3-month GROUP program will include the following fixed components: i) weekly interactive group-based health education sessions focused on: * increasing knowledge, skills, and behaviours related to physical activity, healthy eating, and available community supports for older adults; * socialization to foster peer and community connections, co-learning, and decrease social isolation * skill-building to support independence and quality of life; and ii) INDIVIDUAL tailored system navigation support

The EMBOLDEN program

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Community-dwelling older adults (55 years of age and older) living in a neighbourhood selected for the study.

You may not qualify if:

  • Unable to speak or understand English
  • Unable to walk 10 meters without physical assistance from another person (assistive devices permitted)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Community

Hamilton, Ontario(ON), Canada

RECRUITING

Downtown East Community

Toronto, Ontario(ON), Canada

NOT YET RECRUITING

Related Publications (1)

  • Ganann R, Phillips SM, Neil-Sztramko SE, Fisher K, Alvarez E, Kuspinar A, Newbold KB, Moore C, MacNeil M, Keller H, Teggart K, Thabane L, Agarwal G, Sherifali D, Adams J, Alshaikhahmed A. Study protocol for the randomized controlled trial of EMBOLDEN: a multifaceted intervention aimed at Enhancing physical and community MoBility in OLDEr adults with health inequities using commuNity co-design. Front Public Health. 2025 Apr 24;13:1555222. doi: 10.3389/fpubh.2025.1555222. eCollection 2025.

    PMID: 40342494DERIVED

MeSH Terms

Conditions

Mobility LimitationMotor Activity

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Rebecca Ganann, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline J Moore, BSc(Hons)

CONTACT

905-525-9140camoore@mcmaster.ca

Rebecca Ganann, RN, PhD

CONTACT

905-525-9140ganann@mcmaster.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants and interventionists are not blinded. All data collectors will be independent of the study and blinded to treatment allocation. Statisticians will be blinded to treatment allocation.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Type II hybrid effectiveness-implementation RCT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2021

First Posted

August 17, 2021

Study Start

May 27, 2022

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

May 3, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)