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

Trial Summary

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 data supports the idea that Community-Based Health Program for Healthy Aging is an effective treatment?

The available research shows that the Community-Based Health Program for Healthy Aging, also known as the EMBOLDEN Program, is designed to improve mobility and health in older adults. It focuses on physical activity, nutrition, social participation, and helping people navigate community systems. While the specific data on its effectiveness isn't detailed in the provided information, similar community-based programs have shown benefits. For example, the Lifestyle Interventions and Independence for Elders (LIFE) trial reduced mobility issues by up to 28% in older adults. This suggests that community-based programs like EMBOLDEN could also be effective in improving mobility and health in older adults. ^{1 2 3 4 5}

What safety data exists for the Community-Based Health Program for Healthy Aging?

The provided research does not directly address safety data for the Community-Based Health Program for Healthy Aging or its related interventions like the EMBOLDEN Program. The studies focus on program design, implementation, and effectiveness, but do not specifically report on safety outcomes. Further investigation into specific safety evaluations or trials would be needed to provide a comprehensive answer. ^{1 2 3 6 7}

Is the 3-month community-based mobility and health intervention a promising treatment for healthy aging?

Yes, the 3-month community-based mobility and health intervention, also known as the EMBOLDEN Program, is promising for healthy aging. It helps older adults improve their physical activity, nutrition, social participation, and ability to navigate health systems, especially for those facing barriers in accessing community programs. Community-based approaches like this have shown improvements in health behaviors and access to health services, making them effective for promoting health and preventing disease. ^{1 2 3 6 8}

What is the purpose of this trial?

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

Research Team

Rebecca Ganann, PhD

Principal Investigator

McMaster University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. Canada 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. [2023]

2. England 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. [2023]

3. United States 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. [2022]

4. Switzerland 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. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

The effectiveness of a community-based health promotion program for rural elders: a quasi-experimental design. [2014]

6. United States pubmed.ncbi.nlm.nih.gov

Beyond p Values: A Qualitative Evaluation of the Aging Mastery Program Implementation in Los Angeles County. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

Characteristics of community-based exercise programs for community-dwelling older adults in rural/regional areas: a scoping review. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Effectiveness of Community-Based Health Promotion Interventions in Urban Areas: A Systematic Review. [2021]