Clinical trial NCT05008159: A Community-based Program That Supports Physical Activity, Healthy Eating, Social Participation and System Navigation in Older Adults
Official title: The Enhancing Physical and Community Mobility in Older Adults With Health Inequities Using Community Co-design of a Multifaceted Intervention Incorporating Physical Activity, Healthy Eating, Social Participation, and System Navigation (EMBOLDEN) Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mobility Limitation
Health Related Quality of Life
Healthy Aging
Health Inequity
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
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: The Labarge Centre for Mobility in Aging
name: Canadian Institutes of Health Research (CIHR)
name: Public Health Agency of Canada (PHAC)
First posted: 2021-08-17
Enrollment: 500
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Type II hybrid effectiveness-implementation RCT
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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)

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.

Primary outcomes:
measure: Physical mobility
timeFrame: 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.
Secondary outcomes:
measure: Community mobility
timeFrame: 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.
measure: Life Space mobility
timeFrame: 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.
measure: Physical activity
timeFrame: 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.
measure: Healthy eating and nutritional risk
timeFrame: 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.
measure: Health-related quality of life
timeFrame: 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.
measure: Health-related quality of life
timeFrame: 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.
measure: Loneliness
timeFrame: 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.
measure: Depression
timeFrame: 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.
measure: Collective efficacy
timeFrame: 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.
measure: Food security
timeFrame: 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.
measure: Community Belonging
timeFrame: 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.
measure: Healthcare and social service utilization
timeFrame: 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.
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Community
state: Ontario(ON)
city: Toronto
country: Canada
facility: Downtown East Community
state: Ontario(ON)
Study officials:
affiliation: McMaster University
name: Rebecca Ganann, PhD
role: PRINCIPAL_INVESTIGATOR
References: