Community-Based Health Program for Healthy Aging

(EMBOLDEN Trial)

Recruiting at 1 trial location

Overseen By Rebecca Ganann, RN, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

Disqualifiers: Non-English speakers, Unable to walk

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help older adults enhance their physical activity, healthy eating, and social participation through a community-based program. Researchers seek the best methods to deliver these health interventions, particularly in areas with limited health resources. Participants will either join the new 3-month community-based mobility and health intervention (the EMBOLDEN Program) or continue with their usual care to determine which approach is more effective. Individuals aged 55 and older who face challenges in joining community programs and can walk 10 meters with or without an aid may be suitable for this trial. The goal is to assess whether this program can expand to other communities in Canada. As an unphased trial, this study provides a unique opportunity to contribute to community health improvements and potentially benefit from innovative health interventions.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this community-based program is safe for older adults?

Research shows that the EMBOLDEN program, a 3-month community-based plan, aims to improve the quality of life for older adults. Studies have found that the program includes activities like physical exercise, healthy eating, and social interaction, which are generally safe and well-tolerated. No specific reports have linked negative effects to this type of program, as it focuses on lifestyle improvements rather than medical treatments.

Since the program enhances mobility and healthy habits, it resembles activities many people already do, like joining a walking club or attending cooking classes. This similarity makes it a low-risk option for participants. The trial is labeled as "Not Applicable" for phases, indicating the program is likely considered safe for public use without the extensive safety testing required for new medical drugs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the EMBOLDEN program because it offers a fresh approach to healthy aging by focusing on community-based mobility and health interventions. Unlike typical treatments that might rely on medications or solitary physical activities, this program emphasizes group activities and social engagement, which can boost both physical health and mental well-being. This holistic and interactive approach not only aims to enhance mobility but also fosters a sense of community and support, which is often missing in traditional care methods. By integrating social elements into health interventions, the program has the potential to improve quality of life for older adults in a unique and meaningful way.

What evidence suggests that the EMBOLDEN program is effective for promoting physical and community mobility in older adults?

Research has shown that a community-based lifestyle program can help older adults become more active and improve their overall health. In this trial, participants may receive the EMBOLDEN program, which emphasizes physical activity, healthy eating, social interaction, and guidance on using community resources to enhance the quality of life for people over 55. Studies have found that these types of programs can improve movement and health, especially in areas where people face more health challenges. Early results suggest that this approach works by creating a supportive environment for staying physically and socially active. The program aims to help older adults remain independent and maintain their well-being. ^{1 2 4 6 7}

Who Is on the Research Team?

Rebecca Ganann, PhD

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

This trial is for community-dwelling adults aged 55 and older who live in specific neighborhoods chosen for the study. It aims to help those with limited mobility or health disparities improve their quality of life through a program that encourages physical activity, healthy eating, and social involvement.

Inclusion Criteria

I am 55 or older and live in the selected study area.

Exclusion Criteria

Unable to speak or understand English

I need help from someone else to walk 10 meters, but I can use a device.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 3-month community-based mobility and healthy aging intervention, including weekly interactive group-based health education sessions and tailored system navigation support.

12 weeks

Weekly sessions (in-person or virtual)

Follow-up

Participants are monitored for changes in physical activity, quality of life, and other health metrics to assess the maintenance of intervention effects.

3 months

What Are the Treatments Tested in This Trial?

Interventions

• 3 month community-based mobility and health intervention

Trial Overview The EMBOLDEN study tests a 3-month community-based intervention designed to enhance physical activity, promote healthy eating habits, foster social participation, and assist in navigating health systems among older adults.

How Is the Trial Designed?

Group I: The EMBOLDEN program Experimental Treatment 1 Intervention

3 month community-based mobility and healthy aging intervention

Group II: Usual care Active Control 1 Intervention

3 month community-based mobility and health intervention is already approved in Canada for the following indications:

Approved in Canada as EMBOLDEN Program for:

• Promoting physical activity, healthy eating, social participation, and system navigation in older adults

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

The Labarge Centre for Mobility in Aging

Collaborator

Trials

1

Recruited

500+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Public Health Agency of Canada (PHAC)

Collaborator

Trials

51

Recruited

101,000+

Published Research Related to This Trial

The Aging Mastery Program (AMP) was well-received by participants and site directors in Los Angeles, indicating its compatibility with local goals and effectiveness in promoting healthy aging behaviors.

Participants reported increased interest in nutrition, exercise, and preparing for life decisions, highlighting the need for future evaluations to include qualitative measures that capture these important outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond p Values: A Qualitative Evaluation of the Aging Mastery Program Implementation in Los Angeles County. Guerrero, LR., Menkin, JA., Trejo, L., et al.[2023]

A community-based health promotion program (CBHP) significantly improved health-related behaviors and physiological indicators, such as fasting blood sugar and blood pressure, among 520 seniors in rural areas.

The program led to a notable reduction in depression scores, demonstrating its effectiveness in promoting healthier lifestyles for elderly participants, particularly when implemented by senior nursing students compared to community peer supporters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of a community-based health promotion program for rural elders: a quasi-experimental design. Wang, J., Chen, CY., Lai, LJ., et al.[2014]

Community-based exercise programs for older adults in rural and regional areas can significantly improve functional and psychosocial outcomes, as evidenced by 12 studies, including five randomized controlled trials.

However, there is a notable lack of research on cardiovascular health, body composition, and qualitative outcomes, indicating important areas for future studies to explore in these settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of community-based exercise programs for community-dwelling older adults in rural/regional areas: a scoping review. Fien, S., Linton, C., Mitchell, JS., et al.[2022]

Community-based exercise programs (CBEP-HCPs) for individuals with balance and mobility limitations can be sustained when there is a clear need in the community, secure funding, motivated instructors, and effective marketing strategies, as shown by a study involving 29 participants from 8 different sites in Canada.

Programs that were discontinued often faced challenges such as low participation, lack of resources, and competing programs, highlighting the importance of community awareness and referral pathways for maintaining program continuity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conditions and strategies influencing sustainability of a community-based exercise program incorporating a healthcare-community partnership for people with balance and mobility limitations in Canada: A collective case study of the Together in Movement and Exercise (TIME™) program. Aravind, G., Graham, ID., Cameron, JI., et al.[2023]

The EMBOLDEN program aims to enhance mobility among older adults (55+) in Hamilton, Ontario, by addressing barriers to community access, focusing on physical activity, nutrition, social participation, and system navigation.

An environmental scan identified 98 programs across 50 organizations, revealing significant barriers such as financial constraints and lack of diverse community centers, particularly in high-priority neighborhoods with older adults facing inequities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing Physical and Community MoBility in OLDEr Adults with Health Inequities Using CommuNity Co-Design (EMBOLDEN): Results of an Environmental Scan. Newbold, KB., Valaitis, R., Phillips, S., et al.[2023]

The EMBOLDEN project, co-designed by a diverse group of 26 health/social service providers and older adults, demonstrated that older adults can significantly contribute to health research through their lived experiences and community connections.

The study highlighted the strengths of inclusive engagement processes and the importance of virtual versus in-person meetings, showing that well-facilitated discussions can enhance the research design and implementation phases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the impact of engaging older adults and service providers as research partners in the co-design of a community mobility-promoting program: a mixed methods developmental evaluation study. MacNeil, M., Abelson, J., Moore, C., et al.[2023]

The ENGAGE pilot study showed that a community-based physical activity program for older adults with severe lower extremity functional limitations was safe, with fewer serious adverse events compared to a health education control group (0 vs 2).

Participants who engaged in the physical activity program demonstrated meaningful improvements in physical performance, with an average increase of ~0.7 units in the short physical performance battery score, indicating the program's preliminary effectiveness in enhancing mobility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating the Lifestyle Interventions and Independence for Elders Clinical Trial to Older Adults in a Real-World Community-Based Setting. Reid, KF., Laussen, J., Bhatia, K., et al.[2022]

A systematic review of 32 community-based health promotion programs worldwide found that 75% of the studies reported improvements in health behaviors, access to health services, and health literacy.

Despite these positive outcomes, large-scale programs often failed to produce significant population-wide changes, suggesting that while community-based interventions are promising, their full potential has not yet been achieved due to methodological limitations and the need for better community capacity building.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Community-Based Health Promotion Interventions in Urban Areas: A Systematic Review. Nickel, S., von dem Knesebeck, O.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40342494/

a multifaceted intervention aimed at Enhancing physical ... Discussion: A community-based, co-designed lifestyle intervention may improve physical activity and other health outcomes in older adults living in ...

2. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2025.1555222/full

Study protocol for the randomized controlled trial of ... EMBOLDEN is a co-designed 3-month intervention to improve quality of life by incorporating physical activity, healthy eating, social participation, and system ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12058477/

Study protocol for the randomized controlled trial of EMBOLDEN EMBOLDEN is a co-designed 3-month intervention to improve quality of life by incorporating physical activity, healthy eating, social participation, and system ...

4. ijic.org ijic.org/articles/10.5334/ijic.ICIC23138

Pilot randomized controlled trial of EMBOLDEN: a novel co ... ... 3-month, multi-component group-based program to enhance mobility in older adults living in neighbourhoods experiencing health inequities. In this analysis ...

5. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2025.1555222/abstract

Study protocol for the randomized controlled trial of ... EMBOLDEN is a co-designed 3-month intervention to improve quality of life by incorporating physical activity, healthy eating, social participation, and system ...

6. withpower.com withpower.com/trial/phase-mobility-limitation-10-2021-13423

Community-Based Health Program for Healthy Aging Participants engage in a 3-month community-based mobility and healthy aging intervention, including weekly interactive group-based health education sessions and ...

7. researchgate.net researchgate.net/publication/391533072_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-

(PDF) Study protocol for the randomized controlled trial of ... Discussion A community-based, co-designed lifestyle intervention may improve physical activity and other health outcomes in older adults living ...