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

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McMaster University

Status

Enrolling

Conditions

Health Inequity
Mobility Limitation
Healthy Aging
Health Related Quality of Life

Treatments

Behavioral: 3 month community-based mobility and health intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT05008159
EMBOLDEN

Details and patient eligibility

About

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

Full 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.

Enrollment

500 estimated patients

Sex

All

Ages

55+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

500 participants in 2 patient groups

The EMBOLDEN program
Experimental group
Description:
3 month community-based mobility and healthy aging intervention
Treatment:
Behavioral: 3 month community-based mobility and health intervention
Usual care
No Intervention group

Trial contacts and locations

2

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Central trial contact

Caroline J Moore, BSc(Hons); Rebecca Ganann, RN, PhD

Data sourced from clinicaltrials.gov

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