A Community-based Program That Supports Physical Activity, Healthy Eating, Social Participation and System Navigation in Older Adults

NCT ID: NCT05008159

Last Updated: 2024-05-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-27
• Study Completion Date: 2025-03-31

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

Detailed Description

This is a randomized controlled trial employing a type II hybrid implementation-effectiveness design. This will enable the investigators to evaluate both clinical outcomes and important processes that impact the implementation of the co-designed intervention.

The intervention will consist of 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; this will include facilitated physical activity delivered by a certified exercise physiologist or certified personal trainer with experience and expertise working with older adults and interactive nutrition sessions; socialization to foster peer and community connections, co-learning, and decrease social isolation; and skill-building to support independence and quality of life; and ii) tailored system navigation support to increase access to and use of health and social services systems and address barriers or unmet needs

This trial has a pragmatic design in the following ways: i) recruiting a population with broad inclusion criteria, reflective of the general population of older adults; ii) conducting the study in existing community settings (when in-person delivery is feasible) and virtually, in partnership with organizations already delivering virtual supports due to the pandemic; iii) leveraging existing resources, staff, and service delivery organizations in the intervention arm that are available in usual care; iv) supporting flexibility delivery of the intervention (e.g., tailoring to participant group needs), as would be done through other community programs in usual care; v) flexibility in adherence to the intervention, in ways that are consistent with usual care; vi) selecting primary and secondary outcomes that are participant-relevant; and vii) using intention to treat analyses based on all available data.

The study will be delivered in community settings in urban neighbourhoods identified as areas of health inequities in the cities of Hamilton and Toronto, Ontario.

Conditions

Mobility Limitation; Health Related Quality of Life; Healthy Aging; Health Inequity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

The EMBOLDEN program

3 month community-based mobility and healthy aging intervention

Group Type: EXPERIMENTAL

3 month community-based mobility and health intervention

Intervention Type: BEHAVIORAL

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

Usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Labarge Centre for Mobility in Aging

UNKNOWN

Sponsor Role: collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Public Health Agency of Canada (PHAC)

OTHER_GOV

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rebecca Ganann, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

Community

Hamilton, Ontario(ON), Canada

Site Status: RECRUITING

Downtown East Community

Toronto, Ontario(ON), Canada

Site Status: NOT_YET_RECRUITING

Countries

Canada

Central Contacts

Caroline J Moore, BSc(Hons)

Role: CONTACT

camoore@mcmaster.ca

905-525-9140 ext. 22305

Rebecca Ganann, RN, PhD

Role: CONTACT

ganann@mcmaster.ca

905-525-9140 ext. 22456

Facility Contacts

Caroline Moore

Role: primary

camoore@mcmaster.ca

9055259140 ext. 22305

Caroline Moore

Role: primary

camoore@mcmaster.ca

9055259140 ext. 22305

References

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.

Reference Type: DERIVED

PMID: 40342494 (View on PubMed)

Other Identifiers

EMBOLDEN

Identifier Type: -

Identifier Source: org_study_id