Mobility LimitationEMBOLDENNCT05008159
A Community-based Program That Supports Physical Activity, Healthy Eating, Social Participation and System Navigation in Older Adults
A study testing 3 month community-based mobility and health intervention in people with Mobility Limitation and Health Related Quality of Life, run by McMaster University at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mobility Limitation, Health Related Quality of Life, Healthy Aging
- What is being tested?
- 3 month community-based mobility and health intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 2 sitesCanada
- Study dates
- 27 May 2022to Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Community-dwelling older adults (55 years of age and older) living in a neighbourhood selected for the study.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
Community
Hamilton, Ontario(ON)
Caroline Moore, 9055259140 ext. 22305, camoore@mcmaster.ca
- Not yet recruiting
Downtown East Community
Toronto, Ontario(ON)
Caroline Moore, 9055259140 ext. 22305, camoore@mcmaster.ca
About this study
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
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
Read the 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.
- Being tested
- 3 month community-based mobility and health intervention
- 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
- Medical subject headings
- Mobility Limitation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 month community-based mobility and health interventionBehavioural
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:
- 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
| Study group | Role | What they receive |
|---|---|---|
| The EMBOLDEN program | Experimental | 3 month community-based mobility and healthy aging intervention Receives: Behavioral: 3 month community-based mobility and health intervention |
| Usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical mobility
Change in total weekly minutes spent in light, moderate-to-vigorous physical activity and sedentary activity as measured by an accelerometer worn over 7-day periods.
Measured: 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 (12)
Community mobility
Change in community mobility as measured by GPS-derived quantity of out of home activities
Measured: 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.
Life Space mobility
Change in life space mobility as measured by Life Space Index (LSI)which is a self-reported measure of community mobility with strong psychometric properties . Scores range from 0-120, where a score of 120 characterizes the highest possible level of life-space (i.e. going out of town without assistance). A change of 5 to 10 points on the LSI is considered clinically meaningful.
Measured: 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.
Physical activity
Change in self-reported physical activity as measured by the Physical Activity Scale for the Elderly (PASE).
PASE assesses the types of activities typically chosen by older adults (walking, recreational activities, exercise, housework, yard work, and caring for others. It uses frequency, duration, and intensity level of activity over the previous week to assign a score, ranging from 0 to 793, with higher scores indicating greater physical activity.
Measured: 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.
Healthy eating and nutritional risk
Change in healthy eating and nutritional risk as measured by Seniors in the community: risk evaluation for eating and nutrition, Version II (SCREEN-II). Scores range from 0 to 64. Lower scores on SCREEN II indicate increased risk for impaired nutritional states. Scores <50 indicate high nutrition risk.
Measured: 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.
Health-related quality of life
Change in health-related quality of life as measured by the 12-Item Short Form Survey (SF-12). Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Measured: 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.
Health-related quality of life
Change in health-related quality of life as measured by the EQ-5D-5L. Scores range from -0.281 to 1, where values lower than 0 represent states considered to be worse than death. The instrument also includes a visual analogue scale (EQ-VAS) which provides a single global rating of self-perceived health and is scored on a 0 to 100 mm scale representing "the worst…" and "the best health you can imagine", respectively.
Measured: 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.
Loneliness
Change in loneliness as measured by the 6-item De Jong Gierveld Loneliness scale. The total scale score is the sum of the item scores, ranging from 0 (not lonely) to 11 (extremely lonely). A score of 3 or higher is an indication of loneliness.
Measured: 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.
Depression
Change in depression as measured by the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 score can range from 0 to 27, since each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day).
Major depression is diagnosed if 5 or more of the 9 depressive symptom criteria have been present at least "more than half the days" in the past 2 weeks, and 1 of the symptoms is depressed mood or anhedonia. Other depression is diagnosed if 2, 3, or 4 depressive symptoms have been present at least "more than half the days" in the past 2 weeks, and 1 of the symptoms is depressed mood or anhedonia. One of the 9 symptom criteria ("thoughts that you would be better off dead or of hurting yourself in some way") counts if present at all, regardless of duration. As with the original PRIME-MD, before making a final diagnosis, the clinician is expected to rule out physical causes of depression, normal bereavement, and history of a manic episode.
Measured: 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.
Collective efficacy
Change in the process of engaging and sustaining self-management support in everyday settings measured by the Collective Efficacy of Networks questionnaire (CENS). Scores can range from 12-60, with higher scores indicating higher self-management support.
Measured: 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.
Food security
2 questions validated from the US Department of Agriculture 18-item Household Food Security Survey (HFSS) that identifies risk for food insecurity if the participants answer that either or both of the following two statements is 'often true' or 'sometimes true' (vs. 'never true').
Measured: 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.
Community Belonging
Change in sense of community belonging measured by social capital at the neighbourhood level. This is 1 question taken from the Canadian Community Health Survey: How would you describe your sense of belonging to your local community? Participants choose one of the following options: Very strong; Somewhat strong; Somewhat weak; Very weak.
Measured: 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.
Healthcare and social service utilization
Change in number of emergency room visits, number of hospitalizations, number of primary care and specialist visits.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start27 May 2022
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mobility LimitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Type II hybrid effectiveness-implementation RCT
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- The Labarge Centre for Mobility in Aging, Canadian Institutes of Health Research (CIHR), Public Health Agency of Canada (PHAC)
- Responsible party
- Sponsor
- Investigators
- Rebecca Ganann, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05008159
- Sponsor's protocol ID
- EMBOLDEN
- Acronym
- EMBOLDEN
- Status last verified
- May 2024
- First submitted
- 29 Jul 2021
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40342494
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05008159
- Acronym / sponsor ID
- EMBOLDEN / EMBOLDEN
- Keywords
- Physical Mobility, Aging, Community-based intervention, Public and community engagement, Physical activity, Healthy eating, Social participation, System navigation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- The Labarge Centre for Mobility in Aging, Canadian Institutes of Health Research (CIHR), Public Health Agency of Canada (PHAC)
- Study start
- 27 May 2022 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 17 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Type II hybrid effectiveness-implementation RCT
| Arm | Type | Receives |
|---|---|---|
| The EMBOLDEN program | Experimental | Behavioral: 3 month community-based mobility and health intervention3 month community-based mobility and healthy aging intervention |
| Usual care | No intervention | – |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Community-dwelling older adults (55 years of age and older) living in a neighbourhood selected for the study.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3 month community-based mobility and health intervention12 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 | Behavioural | The EMBOLDEN program |
Primary outcome
Physical mobility
Time frame: 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.
Change in total weekly minutes spent in light, moderate-to-vigorous physical activity and sedentary activity as measured by an accelerometer worn over 7-day periods.
12 secondary outcomes
Community mobility
Time frame: 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.
Life Space mobility
Time frame: 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.
Physical activity
Time frame: 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.
Healthy eating and nutritional risk
Time frame: 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.
Health-related quality of life
Time frame: 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.
Health-related quality of life
Time frame: 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.
Loneliness
Time frame: 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.
Depression
Time frame: 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.
Collective efficacy
Time frame: 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.
Food security
Time frame: 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.
Community Belonging
Time frame: 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.
Healthcare and social service utilization
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Derived from this study: PubMed 40342494Ganann 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.
- Individual participant dataSharing planned: No
Related trials for Mobility Limitation
Not yet recruiting
Supplementary Neuromuscular Rehabilitation During Acute Concussion Recovery
Concussion (Diagnosis), Gait Abnormality
Active, not recruiting
Comparative Effects of Cyriax Approach With and Without Mobilization With Movement in Shoulder Restriction With Rotator Cuff Tendinopathy
Rotator Cuff Tendinopathy
Not yet recruiting
Effects of Low-Load Blood Flow Restriction Resistance Training With and Without Hip Abductor Strengthening in Patients With Knee Osteoarthritis.(BFR)
Knee Osteoarthritis
Active, not recruiting
Effects of Blood Flow Restriction Training and Instrument-Assisted Soft Tissue Mobilization for Pain, Strength, Range of Motion, and Kinesiophobia Among ACL Reconstruction Patients.
ACL Reconstruction
Active, not recruiting
Randomized Clinical Trial to Improve Mobility After Hospitalization
Hypertension, Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Ganann, PhD principal investigator
McMaster University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3 month community-based mobility and health intervention in people with Mobility Limitation and Health Related Quality of Life, run by McMaster University at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caroline J Moore, BSc(Hons) (905-525-9140 ext. 22305, camoore@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical mobility (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05008159, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.