Recruiting

Health Promotion

Sponsor:

McMaster University

Code:

NCT05008159

Conditions

Mobility Limitation

Health Related Quality of Life

Healthy Aging

Health Inequity

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Accepted

Interventions

3 month community-based mobility and health intervention

Study Details

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

Conditions

Mobility Limitation

Health Related Quality of Life

Healthy Aging

Health Inequity

Study ID

NCT05008159

Start date

May 27, 2022

Status verified date

May, 2024

Completion date

Mar, 2025

Anticipated

Primary completion date

Mar, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Accepted

Inclusion criteria:

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

Exclusion criteria:

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

As a pragmatic trial, we have chosen broad inclusion criteria to reflect the characteristics of individuals who may join a program such as this outside of a research study. Thus, we will not exclude individuals based on the presence of existing chronic disease, comorbidities, or other factors that may impact attendance.

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: The EMBOLDEN program

3 month community-based mobility and healthy aging intervention

no intervention: Usual care

Interventions

3 month community-based mobility and health intervention

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

Primary outcome measure

  • Physical mobility [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Caroline J Moore, BSc(Hons)

905-525-9140camoore@mcmaster.ca

Rebecca Ganann, RN, PhD

905-525-9140ganann@mcmaster.ca

Locations

Community

Recruiting

Hamilton, Ontario(ON), Canada

Contacts

More Information

Sponsor

McMaster University

Last update posted

May 3, 2024

Last verified

May, 2024

Keywords

  • Physical Mobility
  • Aging
  • Community-based intervention
  • Public and community engagement
  • Physical activity
  • Healthy eating
  • Social participation
  • System navigation
  • Life-space
  • Community mobility
  • Community integration

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2024-05-03.